Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Immune Response of a HIV Candidate Vaccine After Administration of One Chloroquine Dose

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00972725
Recruitment Status : Completed
First Posted : September 7, 2009
Results First Posted : April 13, 2017
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition AIDS
Interventions Biological: GSK Biologicals' HIV vaccine (732461)
Drug: Chloroquine
Enrollment 28
Recruitment Details  
Pre-assignment Details Out of all the subjects planned for enrollment, only 28 were included in the analyses and hence started the study.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine. Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Period Title: Overall Study
Started 13 15
Completed 13 15
Not Completed 0 0
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group Total
Hide Arm/Group Description Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine. Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 13 15 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 15 participants 28 participants
25.1  (5.33) 24.3  (3.73) 24.67  (4.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
Female
7
  53.8%
10
  66.7%
17
  60.7%
Male
6
  46.2%
5
  33.3%
11
  39.3%
1.Primary Outcome
Title Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens
Hide Description Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by intracellular cytokine staining (ICS).
Time Frame At Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 13
Measure Type: Count of Participants
Unit of Measure: Participants
At least 1 antigen, Day 14
1
   7.7%
3
  23.1%
At least 2 antigens, Day 14
0
   0.0%
0
   0.0%
At least 3 antigens, Day 14
0
   0.0%
0
   0.0%
At least 4 antigens, Day 14
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Subjects With Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time Frame During the 7 Day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 15
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
13
 100.0%
14
  93.3%
Grade 3 Pain
1
   7.7%
2
  13.3%
Any Redness
3
  23.1%
6
  40.0%
Grade 3 Redness
0
   0.0%
1
   6.7%
Any Swelling
3
  23.1%
5
  33.3%
Grade 3 Swelling
0
   0.0%
2
  13.3%
3.Primary Outcome
Title Number of Subjects With Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 7 Day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 15
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue
9
  69.2%
14
  93.3%
Grade 3 Fatigue
3
  23.1%
3
  20.0%
Related Fatigue
9
  69.2%
11
  73.3%
Any Gastrointestinal
6
  46.2%
5
  33.3%
Grade 3 Gastrointestinal
1
   7.7%
0
   0.0%
Related Gastrointestinal
4
  30.8%
3
  20.0%
Any Headache
9
  69.2%
13
  86.7%
Grade 3 Headache
3
  23.1%
0
   0.0%
Related Headache
8
  61.5%
10
  66.7%
Any Temperature
8
  61.5%
10
  66.7%
Grade 3 Temperature
0
   0.0%
1
   6.7%
Related Temperature
7
  53.8%
9
  60.0%
4.Primary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame During the 32 Day (Days 2-29) post-chloroquine administration and during the 30 Day (Days 0-29) post-vaccine administration period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 15
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
8
  61.5%
13
  86.7%
Grade 3 AEs
3
  23.1%
2
  13.3%
Related AEs
5
  38.5%
8
  53.3%
5.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame During the entire study period (from Day 0 up to Day 360)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 15
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Number of Subjects With AEs of Specific Interest and Immune-Mediated Disorders (IMDs)
Hide Description Adverse events of specific interest include auto-immune diseases (AID) and immune mediated disorders such as neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events.
Time Frame During the entire study period (from Day 0 up to Day 360)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 15
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
7.Primary Outcome
Title Levels of Haematological and Biochemical Parameters
Hide Description Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.
Time Frame At Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 15
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Unknown
0
   0.0%
0
   0.0%
ALT, Below
0
   0.0%
0
   0.0%
ALT, Within
13
 100.0%
15
 100.0%
ALT, Above
0
   0.0%
0
   0.0%
ASA, Unknown
0
   0.0%
0
   0.0%
ASA, Below
0
   0.0%
0
   0.0%
ASA, Within
13
 100.0%
15
 100.0%
ASA, Above
0
   0.0%
0
   0.0%
BASO, Unknown
0
   0.0%
0
   0.0%
BASO, Below
3
  23.1%
4
  26.7%
BASO, Within
10
  76.9%
11
  73.3%
BASO, Above
0
   0.0%
0
   0.0%
CREA, Unknown
0
   0.0%
0
   0.0%
CREA, Below
0
   0.0%
0
   0.0%
CREA, Within
12
  92.3%
14
  93.3%
CREA, Above
1
   7.7%
1
   6.7%
EOS, Unknown
0
   0.0%
0
   0.0%
EOS, Below
1
   7.7%
1
   6.7%
EOS, Within
12
  92.3%
14
  93.3%
EOS, Above
0
   0.0%
0
   0.0%
HAEM, Unknown
0
   0.0%
0
   0.0%
HAEM, Below
1
   7.7%
0
   0.0%
HAEM, Within
12
  92.3%
15
 100.0%
HAEM, Above
0
   0.0%
0
   0.0%
HAEMO, Unknown
0
   0.0%
0
   0.0%
HAEMO, Below
0
   0.0%
0
   0.0%
HAEMO, Within
12
  92.3%
15
 100.0%
HAEMO, Above
1
   7.7%
0
   0.0%
LYMPH, Unknown
0
   0.0%
0
   0.0%
LYMPH, Below
1
   7.7%
3
  20.0%
LYMPH, Within
12
  92.3%
12
  80.0%
LYMPH, Above
0
   0.0%
0
   0.0%
MONO, Unknown
0
   0.0%
0
   0.0%
MONO, Below
0
   0.0%
0
   0.0%
MONO, Within
13
 100.0%
14
  93.3%
MONO, Above
0
   0.0%
1
   6.7%
NEU, Unknown
0
   0.0%
0
   0.0%
NEU, Below
2
  15.4%
0
   0.0%
NEU, Within
11
  84.6%
13
  86.7%
NEU, Above
0
   0.0%
2
  13.3%
PLA, Unknown
0
   0.0%
0
   0.0%
PLA, Below
0
   0.0%
0
   0.0%
PLA, Within
13
 100.0%
14
  93.3%
PLA, Above
0
   0.0%
1
   6.7%
RBC, Unknown
0
   0.0%
0
   0.0%
RBC, Below
0
   0.0%
0
   0.0%
RBC, Within
13
 100.0%
15
 100.0%
RBC, Above
0
   0.0%
0
   0.0%
UR, Unknown
0
   0.0%
0
   0.0%
UR, Below
0
   0.0%
0
   0.0%
UR, Within
13
 100.0%
15
 100.0%
UR, Above
0
   0.0%
0
   0.0%
WBC, Unknown
0
   0.0%
0
   0.0%
WBC, Below
0
   0.0%
0
   0.0%
WBC, Within
13
 100.0%
13
  86.7%
WBC, Above
0
   0.0%
2
  13.3%
8.Primary Outcome
Title Levels of Haematological and Biochemical Parameters
Hide Description Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.
Time Frame At Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 15
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Unknown
0
   0.0%
0
   0.0%
ALT, Below
0
   0.0%
0
   0.0%
ALT, Within
13
 100.0%
15
 100.0%
ALT, Above
0
   0.0%
0
   0.0%
ASA, Unknown
0
   0.0%
0
   0.0%
ASA, Below
0
   0.0%
0
   0.0%
ASA, Within
13
 100.0%
15
 100.0%
ASA, Above
0
   0.0%
0
   0.0%
BASO, Unknown
0
   0.0%
0
   0.0%
BASO, Below
3
  23.1%
1
   6.7%
BASO, Within
10
  76.9%
14
  93.3%
BASO, Above
0
   0.0%
0
   0.0%
CREA, Unknown
0
   0.0%
0
   0.0%
CREA, Below
1
   7.7%
1
   6.7%
CREA, Within
11
  84.6%
12
  80.0%
CREA, Above
1
   7.7%
2
  13.3%
EOS, Unknown
1
   7.7%
1
   6.7%
EOS, Below
1
   7.7%
1
   6.7%
EOS, Within
0
   0.0%
0
   0.0%
EOS, Above
1
   7.7%
0
   0.0%
HAEM, Unknown
0
   0.0%
0
   0.0%
HAEM, Below
0
   0.0%
0
   0.0%
HAEM, Within
13
 100.0%
15
 100.0%
HAEM, Above
0
   0.0%
0
   0.0%
HAEMO, Unknown
0
   0.0%
0
   0.0%
HAEMO, Below
0
   0.0%
0
   0.0%
HAEMO, Within
13
 100.0%
15
 100.0%
HAEMO, Above
0
   0.0%
0
   0.0%
LYMPH, Unknown
0
   0.0%
0
   0.0%
LYMPH, Below
0
   0.0%
0
   0.0%
LYMPH, Within
13
 100.0%
15
 100.0%
LYMPH, Above
0
   0.0%
0
   0.0%
MONO, Unknown
0
   0.0%
0
   0.0%
MONO, Below
0
   0.0%
0
   0.0%
MONO, Within
11
  84.6%
15
 100.0%
MONO, Above
2
  15.4%
0
   0.0%
NEU, Unknown
0
   0.0%
0
   0.0%
NEU, Below
2
  15.4%
1
   6.7%
NEU, Within
10
  76.9%
14
  93.3%
NEU, Above
1
   7.7%
0
   0.0%
PLA, Unknown
0
   0.0%
0
   0.0%
PLA, Below
0
   0.0%
0
   0.0%
PLA, Within
13
 100.0%
14
  93.3%
PLA, Above
0
   0.0%
1
   6.7%
RBC, Unknown
0
   0.0%
0
   0.0%
RBC, Below
0
   0.0%
0
   0.0%
RBC, Within
13
 100.0%
15
 100.0%
RBC, Above
0
   0.0%
0
   0.0%
UR, Unknown
0
   0.0%
0
   0.0%
UR, Below
0
   0.0%
0
   0.0%
UR, Within
12
  92.3%
15
 100.0%
UR, Above
1
   7.7%
0
   0.0%
WBC, Unknown
0
   0.0%
0
   0.0%
WBC, Below
0
   0.0%
0
   0.0%
WBC, Within
12
  92.3%
15
 100.0%
WBC, Above
1
   7.7%
0
   0.0%
9.Primary Outcome
Title Levels of Haematological and Biochemical Parameters
Hide Description Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.
Time Frame At Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 15
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Unknown
0
   0.0%
0
   0.0%
ALT, Below
0
   0.0%
0
   0.0%
ALT, Within
13
 100.0%
15
 100.0%
ALT, Above
0
   0.0%
0
   0.0%
ASA, Unknown
0
   0.0%
0
   0.0%
ASA, Below
0
   0.0%
0
   0.0%
ASA, Within
12
  92.3%
15
 100.0%
ASA, Above
1
   7.7%
0
   0.0%
BASO, Unknown
1
   7.7%
0
   0.0%
BASO, Below
2
  15.4%
2
  13.3%
BASO, Within
9
  69.2%
12
  80.0%
BASO, Above
1
   7.7%
1
   6.7%
CREA, Unknown
0
   0.0%
0
   0.0%
CREA, Below
0
   0.0%
0
   0.0%
CREA, Within
13
 100.0%
15
 100.0%
CREA, Above
0
   0.0%
0
   0.0%
EOS, Unknown
1
   7.7%
0
   0.0%
EOS, Below
0
   0.0%
0
   0.0%
EOS, Within
11
  84.6%
15
 100.0%
EOS, Above
1
   7.7%
0
   0.0%
HAEM, Unknown
1
   7.7%
0
   0.0%
HAEM, Below
0
   0.0%
0
   0.0%
HAEM, Within
12
  92.3%
15
 100.0%
HAEM, Above
0
   0.0%
0
   0.0%
HAEMO, Unknown
1
   7.7%
0
   0.0%
HAEMO, Below
0
   0.0%
0
   0.0%
HAEMO, Within
12
  92.3%
15
 100.0%
HAEMO, Above
0
   0.0%
0
   0.0%
LYMPH, Unknown
1
   7.7%
0
   0.0%
LYMPH, Below
1
   7.7%
1
   6.7%
LYMPH, Within
11
  84.6%
14
  93.3%
LYMPH, Above
0
   0.0%
0
   0.0%
MONO, Unknown
1
   7.7%
0
   0.0%
MONO, Below
0
   0.0%
0
   0.0%
MONO, Within
12
  92.3%
14
  93.3%
MONO, Above
0
   0.0%
1
   6.7%
NEU, Unknown
1
   7.7%
0
   0.0%
NEU, Below
3
  23.1%
0
   0.0%
NEU, Within
9
  69.2%
15
 100.0%
NEU, Above
0
   0.0%
0
   0.0%
PLA, Unknown
1
   7.7%
0
   0.0%
PLA, Below
0
   0.0%
0
   0.0%
PLA, Within
12
  92.3%
14
  93.3%
PLA, Above
0
   0.0%
1
   6.7%
RBC, Unknown
1
   7.7%
0
   0.0%
RBC, Below
0
   0.0%
0
   0.0%
RBC, Within
12
  92.3%
15
 100.0%
RBC, Above
0
   0.0%
0
   0.0%
UR, Unknown
0
   0.0%
0
   0.0%
UR, Below
1
   7.7%
0
   0.0%
UR, Within
12
  92.3%
15
 100.0%
UR, Above
0
   0.0%
0
   0.0%
WBC, Unknown
1
   7.7%
0
   0.0%
WBC, Below
1
   7.7%
0
   0.0%
WBC, Within
11
  84.6%
15
 100.0%
WBC, Above
0
   0.0%
0
   0.0%
10.Primary Outcome
Title Levels of Haematological and Biochemical Parameters
Hide Description Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.
Time Frame At Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 15
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, Unknown
0
   0.0%
0
   0.0%
ALT, Below
0
   0.0%
0
   0.0%
ALT, Within
13
 100.0%
15
 100.0%
ALT, Above
0
   0.0%
0
   0.0%
ASA, Unknown
0
   0.0%
0
   0.0%
ASA, Below
0
   0.0%
0
   0.0%
ASA, Within
13
 100.0%
15
 100.0%
ASA, Above
0
   0.0%
0
   0.0%
BASO, Unknown
0
   0.0%
0
   0.0%
BASO, Below
1
   7.7%
2
  13.3%
BASO, Within
12
  92.3%
13
  86.7%
BASO, Above
0
   0.0%
0
   0.0%
CREA, Unknown
0
   0.0%
0
   0.0%
CREA, Below
0
   0.0%
0
   0.0%
CREA, Within
13
 100.0%
15
 100.0%
CREA, Above
0
   0.0%
0
   0.0%
EOS, Unknown
0
   0.0%
0
   0.0%
EOS, Below
1
   7.7%
0
   0.0%
EOS, Within
11
  84.6%
14
  93.3%
EOS, Above
1
   7.7%
1
   6.7%
HAEM, Unknown
0
   0.0%
0
   0.0%
HAEM, Below
0
   0.0%
0
   0.0%
HAEM, Within
13
 100.0%
15
 100.0%
HAEM, Above
0
   0.0%
0
   0.0%
HAEMO, Unknown
0
   0.0%
0
   0.0%
HAEMO, Below
0
   0.0%
0
   0.0%
HAEMO, Within
13
 100.0%
15
 100.0%
HAEMO, Above
0
   0.0%
0
   0.0%
LYMPH, Unknown
0
   0.0%
0
   0.0%
LYMPH, Below
1
   7.7%
3
  20.0%
LYMPH, Within
11
  84.6%
12
  80.0%
LYMPH, Above
1
   7.7%
0
   0.0%
MONO, Unknown
0
   0.0%
0
   0.0%
MONO, Below
0
   0.0%
0
   0.0%
MONO, Within
13
 100.0%
14
  93.3%
MONO, Above
0
   0.0%
1
   6.7%
NEU, Unknown
0
   0.0%
0
   0.0%
NEU, Below
2
  15.4%
1
   6.7%
NEU, Within
10
  76.9%
14
  93.3%
NEU, Above
1
   7.7%
0
   0.0%
PLA, Unknown
0
   0.0%
0
   0.0%
PLA, Below
0
   0.0%
0
   0.0%
PLA, Within
13
 100.0%
14
  93.3%
PLA, Above
0
   0.0%
1
   6.7%
RBC, Unknown
0
   0.0%
0
   0.0%
RBC, Below
0
   0.0%
0
   0.0%
RBC, Within
13
 100.0%
15
 100.0%
RBC, Above
0
   0.0%
0
   0.0%
UR, Unknown
0
   0.0%
0
   0.0%
UR, Below
0
   0.0%
0
   0.0%
UR, Within
13
 100.0%
15
 100.0%
UR, Above
0
   0.0%
0
   0.0%
WBC, Unknown
0
   0.0%
0
   0.0%
WBC, Below
0
   0.0%
0
   0.0%
WBC, Within
12
  92.3%
15
 100.0%
WBC, Above
1
   7.7%
0
   0.0%
11.Secondary Outcome
Title Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
Hide Description Magnitude was defined as the frequency of CD8+ T cells group-specific antigen (Gag) proteins 17, 24; negative regulatory factor (Nef); reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co). Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est). Among the cytokines expressed were IL-2, TNF-α and INF-γ.
Time Frame At Day 0, 7, 14, 30 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 14
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
RT, D0 Number Analyzed 13 participants 14 participants
79.00
(54.00 to 140.00)
89.00
(40.00 to 225.00)
RT, D7 Number Analyzed 12 participants 13 participants
127.50
(49.00 to 227.00)
137.00
(70.00 to 168.00)
RT, D14 Number Analyzed 13 participants 13 participants
94.00
(53.00 to 214.00)
102.00
(40.00 to 187.00)
RT, D30 Number Analyzed 11 participants 13 participants
57.00
(48.00 to 117.00)
85.00
(14.00 to 113.00)
RT, D180 Number Analyzed 13 participants 14 participants
14.00
(14.00 to 44.00)
48.50
(33.00 to 71.00)
Nef, D0 Number Analyzed 13 participants 14 participants
75.00
(46.00 to 121.00)
71.00
(36.00 to 152.00)
Nef, D7 Number Analyzed 12 participants 13 participants
63.50
(30.00 to 146.00)
84.00
(44.00 to 130.00)
Nef, D14 Number Analyzed 13 participants 13 participants
123.00
(93.00 to 184.00)
99.00
(65.00 to 117.00)
Nef, D30 Number Analyzed 11 participants 13 participants
61.00
(38.00 to 116.00)
116.00
(74.00 to 146.00)
Nef, D180 Number Analyzed 13 participants 14 participants
39.00
(14.00 to 74.00)
66.00
(49.00 to 166.00)
P17, D0 Number Analyzed 13 participants 14 participants
104.00
(41.00 to 127.00)
76.00
(33.00 to 165.00)
P17, D7 Number Analyzed 12 participants 13 participants
109.50
(52.50 to 136.50)
88.00
(42.00 to 113.00)
P17, D14 Number Analyzed 13 participants 13 participants
124.00
(38.00 to 178.00)
84.00
(52.00 to 169.00)
P17, D30 Number Analyzed 11 participants 13 participants
18.00
(14.00 to 72.00)
98.00
(49.00 to 120.00)
P17, D180 Number Analyzed 13 participants 14 participants
55.00
(18.00 to 91.00)
80.00
(68.00 to 142.00)
P24, D0 Number Analyzed 13 participants 14 participants
68.00
(44.00 to 96.00)
77.50
(14.00 to 126.00)
P24, D7 Number Analyzed 12 participants 13 participants
93.50
(21.50 to 159.50)
54.00
(40.00 to 94.00)
P24, D14 Number Analyzed 13 participants 13 participants
83.00
(68.00 to 105.00)
91.00
(49.00 to 106.00)
P24, D30 Number Analyzed 11 participants 13 participants
120.00
(73.00 to 134.00)
81.00
(44.00 to 119.00)
P24, D180 Number Analyzed 13 participants 14 participants
62.00
(14.00 to 102.00)
45.00
(14.00 to 79.00)
Pool_F4co, D0 Number Analyzed 13 participants 14 participants
76.00
(36.00 to 120.00)
148.00
(73.00 to 201.00)
Pool_F4co, D7 Number Analyzed 12 participants 13 participants
218.50
(81.50 to 242.50)
129.00
(58.00 to 158.00)
Pool_F4co, D14 Number Analyzed 13 participants 13 participants
92.00
(55.00 to 129.00)
118.00
(76.00 to 168.00)
Pool_F4co, D30 Number Analyzed 11 participants 13 participants
68.00
(16.00 to 132.00)
122.00
(81.00 to 144.00)
Pool_F4co, D180 Number Analyzed 13 participants 14 participants
65.00
(14.00 to 156.00)
74.00
(50.00 to 98.00)
F4co_est, D0 Number Analyzed 13 participants 14 participants
373.00
(271.00 to 453.00)
398.00
(224.00 to 552.00)
F4co_est, D7 Number Analyzed 12 participants 13 participants
448.50
(240.00 to 619.00)
451.00
(329.00 to 534.00)
F4co_est, D14 Number Analyzed 13 participants 13 participants
478.00
(313.00 to 554.00)
450.00
(338.00 to 539.00)
F4co_est, D30 Number Analyzed 11 participants 13 participants
290.00
(246.00 to 429.00)
380.00
(241.00 to 555.00)
F4co_est, D180 Number Analyzed 13 participants 14 participants
226.00
(108.00 to 299.00)
287.50
(230.00 to 374.00)
12.Secondary Outcome
Title Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Hide Description Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS.
Time Frame At Day 0, 7, 14, 30 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 14
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
RT, CD40L+, D0 Number Analyzed 13 participants 14 participants
146.00
(42.00 to 228.00)
123.00
(1.00 to 179.00)
RT, CD40L+, D7 Number Analyzed 12 participants 13 participants
121.50
(1.00 to 272.00)
168.00
(89.00 to 389.00)
RT, CD40L+, D14 Number Analyzed 13 participants 13 participants
91.00
(11.00 to 177.00)
1.00
(1.00 to 83.00)
RT, CD40L+, D30 Number Analyzed 11 participants 13 participants
113.00
(1.00 to 238.00)
27.00
(1.00 to 190.00)
RT, CD40L+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 100.00)
52.50
(1.00 to 178.00)
RT, IL2+, D0 Number Analyzed 13 participants 14 participants
31.00
(1.00 to 42.00)
1.00
(1.00 to 79.00)
RT, IL2+, D7 Number Analyzed 12 participants 13 participants
32.50
(1.00 to 55.00)
1.00
(1.00 to 71.00)
RT, IL2+, D14 Number Analyzed 13 participants 13 participants
64.00
(1.00 to 87.00)
32.00
(1.00 to 60.00)
RT, IL2+, D30 Number Analyzed 11 participants 13 participants
3.00
(1.00 to 54.00)
1.00
(1.00 to 36.00)
RT, IL2+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 27.00)
1.00
(1.00 to 31.00)
RT, TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 28.00)
1.00
(1.00 to 1.00)
RT, TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 19.50)
34.00
(1.00 to 82.00)
RT, TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 21.00)
1.00
(1.00 to 30.00)
RT, TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 30.00)
1.00
(1.00 to 7.00)
RT, TNF+, D180, Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 43.00)
1.00
(1.00 to 40.00)
RT, IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 31.00)
1.00
(1.00 to 34.00)
RT, IFN+, D14 Number Analyzed 13 participants 13 participants
14.00
(1.00 to 30.00)
1.00
(1.00 to 1.00)
RT, IFN+, D30 Number Analyzed 11 participants 13 participants
4.00
(1.00 to 30.00)
1.00
(1.00 to 1.00)
RT, IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 20.00)
RT, CD40L+IL2+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
13.Secondary Outcome
Title Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Hide Description Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time Frame At Day 0, 7, 14, 30 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 14
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
RT, IL2+TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, IL2+TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, IL2+TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 20.00)
RT, IL2+TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, IL2+TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, IL2+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, IL2+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, IL2+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, IL2+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, IL2+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 31.50)
1.00
(1.00 to 20.00)
RT, TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 37.00)
RT, TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, IL2+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, IL2+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, IL2+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, IL2+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, IL2+TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 6.50)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
RT, CD40L+IL2+TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
14.Secondary Outcome
Title Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Hide Description Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS.
Time Frame At Day 0, 7, 14, 30 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 14
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
Nef, CD40L+, D0 Number Analyzed 13 participants 14 participants
155.00
(45.00 to 226.00)
72.50
(1.00 to 166.00)
Nef, CD40L+, D7 Number Analyzed 12 participants 13 participants
90.50
(33.50 to 157.00)
173.00
(30.00 to 280.00)
Nef, CD40L+, D14 Number Analyzed 13 participants 13 participants
122.00
(82.00 to 231.00)
10.00
(1.00 to 81.00)
Nef, CD40L+, D30 Number Analyzed 11 participants 13 participants
191.00
(1.00 to 373.00)
30.00
(1.00 to 107.00)
Nef, CD40L+, D180 Number Analyzed 13 participants 14 participants
134.00
(45.00 to 174.00)
43.50
(1.00 to 169.00)
Nef, IL2+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 55.00)
9.50
(1.00 to 70.00)
Nef, IL2+, D7 Number Analyzed 12 participants 13 participants
22.00
(1.00 to 43.50)
1.00
(1.00 to 30.00)
Nef, IL2+, D14 Number Analyzed 13 participants 13 participants
40.00
(1.00 to 78.00)
59.00
(1.00 to 74.00)
Nef, IL2+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 21.00)
1.00
(1.00 to 74.00)
Nef, IL2+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
26.50
(1.00 to 100.00)
Nef, TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 6.00)
Nef, TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 29.50)
4.00
(1.00 to 60.00)
Nef, TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 35.00)
1.00
(1.00 to 1.00)
Nef, TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 39.00)
1.00
(1.00 to 51.00)
Nef, TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 14.00)
1.00
(1.00 to 20.00)
Nef, IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 34.00)
1.00
(1.00 to 1.00)
Nef, IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 26.00)
1.00
(1.00 to 1.00)
Nef, IFN+, D30 Number Analyzed 11 participants 13 participants
2.00
(1.00 to 31.00)
1.00
(1.00 to 18.00)
Nef, IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 36.00)
Nef, CD40L+IL2+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 14.00)
Nef, CD40L+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 15.00)
Nef, CD40L+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
15.Secondary Outcome
Title Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Hide Description Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time Frame At Day 0, 7, 14, 30 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 14
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
Nef, IL2+TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 35.00)
Nef, IL2+TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, IL2+TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, IL2+TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 21.00)
1.00
(1.00 to 1.00)
Nef, IL2+TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, IL2+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, IL2+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, IL2+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, IL2+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, IL2+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+IL2+TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, IL2+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, IL2+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, IL2+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, IL2+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, IL2+TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Nef, CD40L+IL2+TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
16.Secondary Outcome
Title Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Hide Description Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time Frame At Day 0, 7, 14, 30 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 14
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
P17, CD40L+, D0 Number Analyzed 13 participants 14 participants
65.00
(1.00 to 191.00)
1.00
(1.00 to 158.00)
P17, CD40L+, D7 Number Analyzed 12 participants 13 participants
40.50
(1.00 to 142.00)
34.00
(1.00 to 128.00)
P17, CD40L+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 169.00)
1.00
(1.00 to 33.00)
P17, CD40L+, D30 Number Analyzed 11 participants 13 participants
7.00
(1.00 to 126.00)
13.00
(1.00 to 165.00)
P17, CD40L+, D180 Number Analyzed 13 participants 14 participants
44.00
(1.00 to 73.00)
4.50
(1.00 to 50.00)
P17, IL2+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 28.00)
1.00
(1.00 to 26.00)
P17, IL2+, D7 Number Analyzed 12 participants 13 participants
7.50
(1.00 to 34.00)
21.00
(1.00 to 34.00)
P17, IL2+, D14 Number Analyzed 13 participants 13 participants
25.00
(1.00 to 92.00)
33.00
(1.00 to 60.00)
P17, IL2+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 5.00)
1.00
(1.00 to 35.00)
P17, IL2+, D180 Number Analyzed 13 participants 14 participants
10.00
(1.00 to 61.00)
39.00
(1.00 to 67.00)
P17, TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 65.00)
1.00
(1.00 to 7.00)
P17, TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 45.50)
21.00
(1.00 to 68.00)
P17, TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 36.00)
1.00
(1.00 to 2.00)
P17, TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 50.00)
P17, TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 31.00)
1.00
(1.00 to 20.00)
P17, IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 28.50)
1.00
(1.00 to 1.00)
P17, IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 20.00)
P17, IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 22.00)
1.00
(1.00 to 34.00)
P17, IFN+, D180 Number Analyzed 13 participants 14 participants
3.00
(1.00 to 26.00)
1.00
(1.00 to 23.00)
P17, CD40L+IL2+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
17.Secondary Outcome
Title Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Hide Description Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time Frame At Day 0, 7, 14, 30 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 14
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
P17, IL2+TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, IL2+TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, IL2+TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, IL2+TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 16.00)
P17, IL2+TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, IL2+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, IL2+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, IL2+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, IL2+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, IL2+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 7.50)
1.00
(1.00 to 1.00)
P17, TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, IL2+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, IL2+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, IL2+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, IL2+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, IL2+TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
p17, CD40L+IL2+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P17, CD40L+IL2+TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
18.Secondary Outcome
Title Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Hide Description Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time Frame At Day 0, 7, 14, 30 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 14
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
P24, CD40L+, D0 Number Analyzed 13 participants 14 participants
178.00
(1.00 to 219.00)
103.50
(1.00 to 163.00)
P24, CD40L+, D7 Number Analyzed 12 participants 13 participants
61.50
(2.50 to 138.00)
37.00
(1.00 to 219.00)
P24, CD40L+, D14 Number Analyzed 13 participants 13 participants
100.00
(17.00 to 171.00)
30.00
(1.00 to 130.00)
P24, CD40L+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 179.00)
59.00
(1.00 to 133.00)
P24, CD40L+, D180 Number Analyzed 13 participants 14 participants
16.00
(1.00 to 210.00)
1.00
(1.00 to 37.00)
P24, IL2+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 14.00)
1.00
(1.00 to 37.00)
P24, IL2+, D7 Number Analyzed 12 participants 13 participants
7.50
(1.00 to 43.00)
1.00
(1.00 to 26.00)
P24, IL2+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 54.00)
1.00
(1.00 to 38.00)
P24, IL2+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 54.00)
32.00
(1.00 to 73.00)
P24, IL2+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 53.00)
1.00
(1.00 to 34.00)
P24, TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 55.00)
1.00
(1.00 to 1.00)
P24, TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 32.00)
27.00
(1.00 to 55.00)
P24, TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 41.00)
1.00
(1.00 to 1.00)
P24, TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 60.00)
1.00
(1.00 to 23.00)
P24, TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 21.00)
P24, IFN+, D0 Number Analyzed 13 participants 14 participants
5.00
(1.00 to 55.00)
1.00
(1.00 to 56.00)
P24, IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 35.00)
1.00
(1.00 to 1.00)
P24, IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 36.00)
1.00
(1.00 to 1.00)
P24, IFN+, D30 Number Analyzed 11 participants 13 participants
25.00
(1.00 to 44.00)
1.00
(1.00 to 42.00)
P24, IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 25.00)
1.00
(1.00 to 19.00)
P24, CD40L+IL2+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
19.Secondary Outcome
Title Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Hide Description Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time Frame At Day 0, 7, 14, 30 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 14
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
P24, IL2+TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, IL2+TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, IL2+TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, IL2+TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, IL2+TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, IL2+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, IL2+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, IL2+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, IL2+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, IL2+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 34.00)
P24, TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, IL2+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, IL2+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, IL2+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, IL2+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, IL2+TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
P24, CD40L+IL2+TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
20.Secondary Outcome
Title Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Hide Description Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).
Time Frame At Day 0, 7, 14, 30 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 14
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
Pool_F4co, CD40L+, D0 Number Analyzed 13 participants 14 participants
114.00
(1.00 to 264.00)
105.00
(1.00 to 256.00)
Pool_F4co, CD40L+, D7 Number Analyzed 12 participants 13 participants
141.50
(37.50 to 235.00)
185.00
(109.00 to 223.00)
Pool_F4co, CD40L+, D14 Number Analyzed 13 participants 13 participants
113.00
(78.00 to 181.00)
1.00
(1.00 to 69.00)
Pool_F4co, CD40L+, D30 Number Analyzed 11 participants 13 participants
84.00
(7.00 to 251.00)
69.00
(1.00 to 192.00)
Pool_F4co, CD40L+, D180 Number Analyzed 13 participants 14 participants
61.00
(42.00 to 107.00)
48.00
(1.00 to 173.00)
Pool_F4co, IL2+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 28.00)
22.00
(1.00 to 54.00)
Pool_F4co, IL2+, D7 Number Analyzed 12 participants 13 participants
26.00
(1.00 to 132.00)
3.00
(1.00 to 85.00)
Pool_F4co, IL2+, D14 Number Analyzed 13 participants 13 participants
31.00
(1.00 to 54.00)
32.00
(15.00 to 84.00)
Pool_F4co, IL2+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 88.00)
20.00
(1.00 to 68.00)
Pool_F4co, IL2+, D180 Number Analyzed 13 participants 14 participants
27.00
(1.00 to 89.00)
1.00
(1.00 to 57.00)
Pool_F4co, TNF+, D0 ] Number Analyzed 13 participants 14 participants
1.00
(1.00 to 32.00)
1.00
(1.00 to 23.00)
Pool_F4co, TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 28.50)
5.00
(1.00 to 33.00)
Pool_F4co, TNF+, D14 Number Analyzed 13 participants 13 participants
2.00
(1.00 to 32.00)
1.00
(1.00 to 72.00)
Pool_F4co, TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 14.00)
1.00
(1.00 to 35.00)
Pool_F4co, TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 17.00)
28.00
(1.00 to 78.00)
Pool_F4co, IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 15.00)
14.00
(1.00 to 33.00)
Pool_F4co, IFN+, D14 Number Analyzed 13 participants 13 participants
5.00
(1.00 to 33.00)
1.00
(1.00 to 27.00)
Pool_F4co, IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
17.00
(1.00 to 38.00)
Pool_F4co, IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 41.00)
1.00
(1.00 to 33.00)
Pool_F4co, CD40L+IL2+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 31.50)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 27.50)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
21.Secondary Outcome
Title Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Hide Description Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).
Time Frame At Day 0, 7, 14, 30 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 14
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
Pool_F4co, IL2+TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, IL2+TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, IL2+TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 28.00)
1.00
(1.00 to 1.00)
Pool_F4co, IL2+TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, IL2+TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, IL2+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, IL2+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, IL2+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, IL2+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, IL2+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 5.00)
1.00
(1.00 to 1.00)
Pool_F4co, TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 13.00)
1.00
(1.00 to 14.00)
Pool_F4co, TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 23.00)
Pool_F4co, TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+TNF+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+TNF+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 7.50)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+TNF+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+TNF+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+TNF+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, IL2+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, IL2+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, IL2+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, IL2+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, IL2+TNF+IFN+, D180 [ Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Pool_F4co, CD40L+IL2+TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
22.Secondary Outcome
Title Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Hide Description Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).
Time Frame At Day 0, 7, 14, 30 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 14
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
F4co_est, CD40L+, D0
608.00
(206.00 to 746.00)
301.00
(139.00 to 603.00)
F4co_est, CD40L+, D7
359.50
(238.00 to 603.50)
532.00
(191.00 to 834.00)
F4co_est, CD40L+, D14
375.00
(237.00 to 717.00)
201.00
(94.00 to 305.00)
F4co_est, CD40L+, D30
347.00
(21.00 to 783.00)
242.00
(71.00 to 693.00)
F4co_est, CD40L+, D180
278.00
(100.00 to 534.00)
150.00
(67.00 to 346.00)
F4co_est, IL2+, D0
77.00
(45.00 to 131.00)
64.00
(26.00 to 143.00)
F4co_est, IL2+, D7
129.00
(41.00 to 164.00)
84.00
(35.00 to 188.00)
F4co_est, IL2+, D14
122.00
(68.00 to 305.00)
141.00
(71.00 to 253.00)
F4co_est, IL2+, D30
22.00
(4.00 to 151.00)
73.00
(38.00 to 168.00)
F4co_est, IL2+, D180
85.00
(6.00 to 128.00)
127.50
(46.00 to 169.00)
F4co_est, TNF+, D0
112.00
(4.00 to 163.00)
9.50
(4.00 to 30.00)
F4co_est, TNF+, D7
57.50
(17.00 to 140.00)
176.00
(24.00 to 248.00)
F4co_est, TNF+, D14
55.00
(4.00 to 147.00)
4.00
(4.00 to 86.00)
F4co_est, TNF+, D30
4.00
(4.00 to 160.00)
67.00
(4.00 to 140.00)
F4co_est, TNF+, D180
4.00
(4.00 to 28.00)
14.50
(4.00 to 68.00)
F4co_est, IFN+, D0
60.00
(8.00 to 105.00)
58.50
(17.00 to 133.00)
F4co_est, IFN+, D7
36.00
(4.00 to 133.50)
29.00
(4.00 to 70.00)
F4co_est, IFN+, D14
56.00
(39.00 to 86.00)
21.00
(4.00 to 84.00)
F4co_est, IFN+, D30
52.00
(8.00 to 130.00)
22.00
(4.00 to 109.00)
F4co_est, IFN+, D180
30.00
(6.00 to 66.00)
23.50
(4.00 to 86.00)
F4co_est, CD40L+IL2+, D0
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+, D7
4.00
(4.00 to 9.50)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+, D14
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+, D30
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+, D180
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+TNF+, D0
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+TNF+, D7
4.00
(4.00 to 36.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+TNF+, D14
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+TNF+, D30
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+TNF+, D180
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IFN+, D0
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IFN+, D7
4.00
(4.00 to 23.50)
5.00
(4.00 to 24.00)
F4co_est, CD40L+IFN+, D14
4.00
(4.00 to 17.00)
4.00
(4.00 to 30.00)
F4co_est, CD40L+IFN+, D30
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IFN+, D180
4.00
(4.00 to 28.00)
4.00
(4.00 to 22.00)
23.Secondary Outcome
Title Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Hide Description Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).
Time Frame At Day 0, 7, 14, 30 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 14
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
F4co_est, IL2+TNF+, D0 Number Analyzed 13 participants 14 participants
4.00
(4.00 to 64.00)
28.00
(4.00 to 43.00)
F4co_est, IL2+TNF+, D7 Number Analyzed 12 participants 13 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 23.00)
F4co_est, IL2+TNF+, D14 Number Analyzed 13 participants 13 participants
4.00
(4.00 to 32.00)
4.00
(4.00 to 23.00)
F4co_est, IL2+TNF+, D30 Number Analyzed 11 participants 13 participants
4.00
(4.00 to 44.00)
4.00
(4.00 to 27.00)
F4co_est, IL2+TNF+, D180 Number Analyzed 13 participants 14 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, IL2+IFN+, D0 Number Analyzed 13 participants 14 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, IL2+IFN+, D7 Number Analyzed 12 participants 13 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, IL2+IFN+, D14 Number Analyzed 13 participants 13 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, IL2+IFN+, D30 Number Analyzed 11 participants 13 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, IL2+IFN+, D180 Number Analyzed 13 participants 14 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
4.00
(4.00 to 5.00)
4.00
(4.00 to 43.00)
F4co_est, TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
15.50
(4.00 to 50.00)
23.00
(4.00 to 40.00)
F4co_est, TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
4.00
(4.00 to 29.00)
4.00
(4.00 to 29.00)
F4co_est, TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
4.00
(4.00 to 27.00)
27.00
(4.00 to 78.00)
F4co_est, TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
4.00
(4.00 to 5.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+TNF+, D0 Number Analyzed 13 participants 14 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+TNF+, D7 Number Analyzed 12 participants 13 participants
4.00
(4.00 to 25.50)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+TNF+, D14 Number Analyzed 13 participants 13 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+TNF+, D30 Number Analyzed 11 participants 13 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+TNF+, D180 Number Analyzed 13 participants 14 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+IFN+, D0 Number Analyzed 13 participants 14 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+IFN+, D7 Number Analyzed 12 participants 13 participants
4.00
(4.00 to 30.50)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+IFN+, D14 Number Analyzed 13 participants 13 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+IFN+, D30 Number Analyzed 11 participants 13 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+IFN+, D180 Number Analyzed 13 participants 14 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
4.00
(4.00 to 9.50)
4.00
(4.00 to 4.00)
F4co_est, CD40+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, IL2+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, IL2+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, IL2+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, IL2+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, IL2+TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+TNF+IFN+, D0 Number Analyzed 13 participants 14 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+TNF+IFN+, D7 Number Analyzed 12 participants 13 participants
4.00
(4.00 to 9.50)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+TNF+IFN+, D14 Number Analyzed 13 participants 13 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+TNF+IFN+, D30 Number Analyzed 11 participants 13 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
F4co_est, CD40L+IL2+TNF+IFN+, D180 Number Analyzed 13 participants 14 participants
4.00
(4.00 to 4.00)
4.00
(4.00 to 4.00)
24.Secondary Outcome
Title Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
Hide Description Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by ICS.
Time Frame At Day 0, 7, 14, 30 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 14
Measure Type: Count of Participants
Unit of Measure: Participants
1 antigen, Day 0 Number Analyzed 13 participants 14 participants
12
  92.3%
11
  78.6%
1 antigen, Day 7 Number Analyzed 12 participants 13 participants
12
 100.0%
12
  92.3%
1 antigen, Day 14 Number Analyzed 13 participants 13 participants
12
  92.3%
12
  92.3%
1 antigen, Day 30 Number Analyzed 11 participants 13 participants
8
  72.7%
13
 100.0%
1 antigen, Day 180 Number Analyzed 13 participants 14 participants
13
 100.0%
14
 100.0%
2 antigens, Day 0 Number Analyzed 13 participants 14 participants
10
  76.9%
11
  78.6%
2 antigens, Day 7 Number Analyzed 12 participants 13 participants
11
  91.7%
11
  84.6%
2 antigens, Day 14 Number Analyzed 13 participants 13 participants
12
  92.3%
11
  84.6%
2 antigens, Day 30 Number Analyzed 11 participants 13 participants
7
  63.6%
13
 100.0%
2 antigens, Day 180 Number Analyzed 13 participants 14 participants
11
  84.6%
13
  92.9%
3 antigens, Day 0 Number Analyzed 13 participants 14 participants
6
  46.2%
4
  28.6%
3 antigens, Day 7 Number Analyzed 12 participants 13 participants
10
  83.3%
10
  76.9%
3 antigens, Day 14 Number Analyzed 13 participants 13 participants
10
  76.9%
10
  76.9%
3 antigens, Day 30 Number Analyzed 11 participants 13 participants
7
  63.6%
10
  76.9%
3 antigens, Day 180 Number Analyzed 13 participants 14 participants
10
  76.9%
9
  64.3%
4 antigens, Day 0 Number Analyzed 13 participants 14 participants
1
   7.7%
3
  21.4%
4 antigens, Day 7 Number Analyzed 12 participants 13 participants
6
  50.0%
8
  61.5%
4 antigens, Day 14 Number Analyzed 13 participants 13 participants
6
  46.2%
8
  61.5%
4 antigens, Day 30 Number Analyzed 11 participants 13 participants
7
  63.6%
6
  46.2%
4 antigens, Day 180 Number Analyzed 13 participants 14 participants
3
  23.1%
4
  28.6%
25.Secondary Outcome
Title Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
Hide Description Magnitude was defined as the frequency of CD4+ T cells group-specific antigen (Gag) proteins 17, 24, negative regulatory factor (Nef), reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co). Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est). Among the cytokines expressed were IL-2, TNF-α and INF-γ.
Time Frame At Day 0, 7, 14, 30 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 14
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
RT, Day 0 Number Analyzed 13 participants 14 participants
846.00
(616.00 to 1252.00)
1125.50
(373.00 to 2290.00)
RT, Day 7 Number Analyzed 12 participants 13 participants
2407.00
(1477.50 to 4566.00)
3286.00
(1788.00 to 5334.00)
RT, Day 14 Number Analyzed 13 participants 13 participants
3162.00
(1393.00 to 4433.00)
3461.00
(2931.00 to 3868.00)
RT, Day 30 Number Analyzed 11 participants 13 participants
2088.00
(54.00 to 4545.00)
2459.00
(1897.00 to 3334.00)
RT, Day 180 Number Analyzed 13 participants 14 participants
1205.00
(1037.00 to 2518.00)
1684.00
(919.00 to 2566.00)
Nef, Day 0 Number Analyzed 13 participants 14 participants
259.00
(206.00 to 310.00)
161.00
(98.00 to 589.00)
Nef, Day 7 Number Analyzed 12 participants 13 participants
586.50
(345.50 to 961.50)
739.00
(324.00 to 1292.00)
Nef, Day 14 Number Analyzed 13 participants 13 participants
890.00
(271.00 to 1362.00)
560.00
(227.00 to 1223.00)
Nef, Day 30 Number Analyzed 11 participants 13 participants
627.00
(84.00 to 1731.00)
386.00
(199.00 to 945.00)
Nef, Day 180 Number Analyzed 13 participants 14 participants
305.00
(245.00 to 518.00)
306.50
(162.00 to 785.00)
P17, Day 0 Number Analyzed 13 participants 14 participants
154.00
(121.00 to 264.00)
176.00
(135.00 to 417.00)
P17, Day 7 Number Analyzed 12 participants 13 participants
464.00
(119.00 to 835.50)
500.00
(127.00 to 1678.00)
P17, Day 14 Number Analyzed 13 participants 13 participants
453.00
(160.00 to 593.00)
503.00
(200.00 to 1224.00)
P17, Day 30 Number Analyzed 11 participants 13 participants
397.00
(44.00 to 1207.00)
346.00
(232.00 to 981.00)
P17, Day 180 Number Analyzed 13 participants 14 participants
278.00
(123.00 to 423.00)
523.00
(172.00 to 837.00)
P24, Day 0 Number Analyzed 13 participants 14 participants
477.00
(322.00 to 642.00)
434.00
(57.00 to 934.00)
P24, Day 7 Number Analyzed 12 participants 13 participants
872.50
(435.00 to 1700.00)
911.00
(549.00 to 1507.00)
P24, Day 14 Number Analyzed 13 participants 13 participants
1198.00
(582.00 to 1653.00)
827.00
(492.00 to 1569.00)
P24, Day 30 Number Analyzed 11 participants 13 participants
641.00
(152.00 to 1136.00)
793.00
(492.00 to 1285.00)
P24, Day 180 Number Analyzed 13 participants 14 participants
530.00
(396.00 to 714.00)
536.50
(302.00 to 826.00)
Pool_F4co, Day 0 Number Analyzed 13 participants 14 participants
1421.00
(965.00 to 2045.00)
2006.50
(1135.00 to 4228.00)
Pool_F4co, Day 7 Number Analyzed 12 participants 13 participants
3881.00
(2480.00 to 6982.00)
5515.00
(4179.00 to 7947.00)
Pool_F4co, Day 14 Number Analyzed 13 participants 13 participants
4898.00
(2446.00 to 7829.00)
5651.00
(4961.00 to 6599.00)
Pool_F4co, Day 30 Number Analyzed 11 participants 13 participants
3791.00
(322.00 to 6073.00)
4138.00
(3485.00 to 5158.00)
Pool_F4co, Day 180 Number Analyzed 13 participants 14 participants
2238.00
(1983.00 to 3956.00)
2856.50
(2233.00 to 4441.00)
F4co_est, Day 0 Number Analyzed 13 participants 14 participants
2000.00
(1492.00 to 2313.00)
1974.50
(1195.00 to 4657.00)
F4co_est, Day 7 Number Analyzed 12 participants 13 participants
4390.00
(2708.00 to 7841.00)
6613.00
(4980.00 to 8883.00)
F4co_est, Day 14 Number Analyzed 13 participants 13 participants
5272.00
(2772.00 to 8751.00)
6035.00
(5437.00 to 7244.00)
F4co_est, Day 30 Number Analyzed 11 participants 13 participants
4407.00
(354.00 to 7708.00)
4589.00
(3458.00 to 5266.00)
F4co_est, Day 180 Number Analyzed 13 participants 14 participants
2530.00
(2151.00 to 4596.00)
3079.00
(2448.00 to 5123.00)
26.Secondary Outcome
Title Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Hide Description Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time Frame At Day 0, 7, 14, 30 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 14
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
RT, CD40L+, D0 Number Analyzed 13 participants 14 participants
163.00
(52.00 to 240.00)
184.00
(13.00 to 299.00)
RT, CD40L+, D7 Number Analyzed 12 participants 13 participants
1080.50
(603.00 to 2695.50)
1209.00
(469.00 to 1534.00)
RT, CD40L+, D14 Number Analyzed 13 participants 13 participants
522.00
(106.00 to 1170.00)
748.00
(168.00 to 994.00)
RT, CD40L+, D30 Number Analyzed 11 participants 13 participants
262.00
(1.00 to 869.00)
309.00
(233.00 to 543.00)
RT, CD40L+, D180 Number Analyzed 13 participants 14 participants
229.00
(159.00 to 346.00)
249.00
(135.00 to 420.00)
RT, IL2+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 27.00)
15.00
(12.00 to 82.00)
RT, IL2+, D7 Number Analyzed 12 participants 13 participants
85.50
(58.00 to 130.50)
42.00
(14.00 to 76.00)
RT, IL2+, D14 Number Analyzed 13 participants 13 participants
97.00
(34.00 to 121.00)
35.00
(15.00 to 80.00)
RT, IL2+, D30 Number Analyzed 11 participants 13 participants
24.00
(1.00 to 69.00)
36.00
(28.00 to 68.00)
RT, IL2+, D180 Number Analyzed 13 participants 14 participants
41.00
(1.00 to 79.00)
74.00
(41.00 to 104.00)
RT, TNF+, D0 Number Analyzed 13 participants 14 participants
18.00
(1.00 to 143.00)
61.50
(1.00 to 286.00)
RT, TNF+, D7 Number Analyzed 12 participants 13 participants
421.00
(130.50 to 504.50)
312.00
(141.00 to 481.00)
RT, TNF+, D14 Number Analyzed 13 participants 13 participants
228.00
(149.00 to 264.00)
318.00
(84.00 to 479.00)
RT, TNF+, D30 Number Analyzed 11 participants 13 participants
124.00
(2.00 to 191.00)
231.00
(42.00 to 287.00)
RT, TNF+, D180 Number Analyzed 13 participants 14 participants
74.00
(16.00 to 81.00)
7.00
(1.00 to 54.00)
RT, IFN+, D0 Number Analyzed 13 participants 14 participants
7.00
(1.00 to 24.00)
13.00
(1.00 to 14.00)
RT, IFN+, D7 Number Analyzed 12 participants 13 participants
91.50
(18.00 to 143.00)
56.00
(13.00 to 81.00)
RT, IFN+, D14 Number Analyzed 13 participants 13 participants
9.00
(1.00 to 16.00)
16.00
(1.00 to 56.00)
RT, IFN+, D30 Number Analyzed 11 participants 13 participants
1.00
(1.00 to 27.00)
1.00
(1.00 to 14.00)
RT, IFN+, D180 Number Analyzed 13 participants 14 participants
13.00
(1.00 to 53.00)
12.50
(1.00 to 41.00)
RT, CD40L+IL2+, D0 Number Analyzed 13 participants 14 participants
377.00
(149.00 to 579.00)
315.00
(121.00 to 544.00)
RT, CD40L+IL2+, D7 Number Analyzed 12 participants 13 participants
924.00
(544.00 to 1793.50)
1424.00
(549.00 to 2016.00)
RT, CD40L+IL2+, D14 Number Analyzed 13 participants 13 participants
922.00
(413.00 to 1702.00)
990.00
(556.00 to 1286.00)
RT, CD40L+IL2+, D30 Number Analyzed 11 participants 13 participants
615.00
(1.00 to 1053.00)
828.00
(516.00 to 1127.00)
RT, CD40L+IL2+, D180 Number Analyzed 13 participants 14 participants
558.00
(447.00 to 866.00)
797.50
(364.00 to 1013.00)
RT, CD40L+TNF+, D0 Number Analyzed 13 participants 14 participants
41.00
(6.00 to 53.00)
36.50
(14.00 to 110.00)
RT, CD40L+TNF+, D7 Number Analyzed 12 participants 13 participants
237.00
(103.00 to 469.00)
315.00
(95.00 to 373.00)
RT, CD40L+TNF+, D14 Number Analyzed 13 participants 13 participants
300.00
(107.00 to 410.00)
291.00
(199.00 to 432.00)
RT, CD40L+TNF+, D30 Number Analyzed 11 participants 13 participants
204.00
(36.00 to 314.00)
137.00
(131.00 to 156.00)
RT, CD40L+TNF+, D180 Number Analyzed 13 participants 14 participants
54.00
(21.00 to 68.00)
40.50
(27.00 to 66.00)
RT, CD40L+IFN+, D0 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 7.00)
1.00
(1.00 to 1.00)
RT, CD40L+IFN+, D7 Number Analyzed 12 participants 13 participants
69.00
(18.50 to 160.00)
84.00
(14.00 to 126.00)
RT, CD40L+IFN+, D14 Number Analyzed 13 participants 13 participants
27.00
(14.00 to 83.00)
28.00
(14.00 to 69.00)
RT, CD40L+IFN+, D30 Number Analyzed 11 participants 13 participants
14.00
(1.00 to 32.00)
15.00
(14.00 to 30.00)
RT, CD40L+IFN+, D180 Number Analyzed 13 participants 14 participants
1.00
(1.00 to 14.00)
14.00
(1.00 to 24.00)
27.Secondary Outcome
Title Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Hide Description Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Time Frame At Day 0, 7, 14, 30 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK732461+Nivaquine Group GSK732461 Group
Hide Arm/Group Description:
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 13 14
Median (Inter-Quartile Range)
Unit of Measure: T cells/million cells
RT, IL2+TNF+, D0 Number Analyzed 13 participants 14 participants
14.00
(2.00 to 42.00)
6.50
(1.00 to 43.00)