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Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America

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ClinicalTrials.gov Identifier: NCT00312702
Recruitment Status : Completed
First Posted : April 10, 2006
Results First Posted : November 26, 2018
Last Update Posted : November 26, 2018
Sponsor:
Collaborators:
GlaxoSmithKline
The PATH Malaria Vaccine Initiative (MVI)
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Malaria
Plasmodium Falciparum Malaria
Intervention Biological: Falciparum Malaria Protein 11 with AS02A adjuvant
Enrollment 18
Recruitment Details 18 immunized, 12 IC's from high dose group and 6 control subject
Pre-assignment Details 18 subjects were randomly assigned to the immunization phase for each of the 2 vaccine formulations. 12 IC's from high does group and 1 non immunized infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report.
Arm/Group Title 10µg Dose FMP011 50µg Dose FMP011 Infectivity Controls (IC)
Hide Arm/Group Description

Falciparum Malaria Protein 11 with AS02A adjuvant

Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine

Falciparum Malaria Protein 11 with AS02A adjuvant

Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine

12 Subjects from the high dose group and 1 non immunized subject enrolled prior to challenge to serve as IC's for malaria sporozoite challenge.

1 infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report.

Period Title: Immunization Phase
Started 5 13 0
Completed 5 12 0
Not Completed 0 1 0
Reason Not Completed
Lost to Follow-up             0             1             0
Period Title: Challenge Phase
Started 0 [1] 12 [2] 1 [3]
Completed 0 12 1
Not Completed 0 0 0
[1]
low dose subjects didn't participate in the challenge phase
[2]
12 subjects from the high dose group participated in the challenge phase
[3]
1 non-immunized subjects participated in the challenge phase.
Arm/Group Title 10µg Dose FMP011 50µg Dose FMP011 Infectivity Control (IC) Total
Hide Arm/Group Description

Falciparum Malaria Protein 11 with AS02A adjuvant

Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine

Falciparum Malaria Protein 11 with AS02A adjuvant

Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine

12 Subjects from the high dose group and 1 non immunized subject enrolled prior to challenge to serve as IC's for malaria sporozoite challenge.

1 infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report.

Total of all reporting groups
Overall Number of Baseline Participants 5 13 1 19
Hide Baseline Analysis Population Description
12 Subjects from the high dose group and 1 non immunized subject enrolled prior to challenge to serve as IC's for malaria sporozoite challenge.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 13 participants 1 participants 19 participants
25.4  (6.2) 32.8  (8.2) 34.5  (0.0) 30.7  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 13 participants 1 participants 19 participants
Female
2
  40.0%
7
  53.8%
1
 100.0%
10
  52.6%
Male
3
  60.0%
6
  46.2%
0
   0.0%
9
  47.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 13 participants 1 participants 19 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
5
 100.0%
13
 100.0%
1
 100.0%
19
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 13 participants 1 participants 19 participants
American Indian or Alaska Native
0
   0.0%
1
   7.7%
0
   0.0%
1
   5.3%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
5
 100.0%
11
  84.6%
1
 100.0%
17
  89.5%
More than one race
0
   0.0%
1
   7.7%
0
   0.0%
1
   5.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 13 participants 1 participants 19 participants
5 13 1 18
1.Primary Outcome
Title Safety - Most Frequently Reported Adverse Events and Grade
Hide Description

An AE was defined as any reaction, side effect, or untoward event that occurred during the course of the trial whether or not the event was considered related to study drug or clinically significant.

Grade 1: Mild Grade 2: Moderate Grade 3: Severe

Time Frame 30 days post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The AE's were tabulated and summarized by subject and treatment groups. No additional analyses were performed. Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe Infectivity Controls were not included in this analysis.
Arm/Group Title 10µg Dose FMP011 50µg Dose FMP011 Infectivity Control
Hide Arm/Group Description:

Falciparum Malaria Protein 11 with AS02A adjuvant

Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine

Falciparum Malaria Protein 11 with AS02A adjuvant

Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine

12 Subjects from the high dose group and 1 non immunized subject enrolled prior to challenge to serve as IC's for malaria sporozoite challenge.

1 infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report.

Overall Number of Participants Analyzed 5 13 1
Measure Type: Number
Unit of Measure: Number of adverse events
Pain - Grade 1 3 10 0
Pain - Grade 2 2 3 0
Pain - Grade 3 0 0 0
Redness - Grade 1 3 1 0
Redness - Grade 2 0 0 0
Redness - Grade 3 0 1 0
Swelling - Grade 1 1 1 0
Swelling - Grade 2 0 1 0
Swelling - Grade 3 0 0 0
2.Secondary Outcome
Title Anti-LSA-1 Antibody Response in Titer Units
Hide Description Anti-LSA-1 Antibody Response in Titer Units on days 0, 28, 42 and 84
Time Frame days 0, 28, 42 (challenge day) and 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Low dose group didn't participate in challenge (day 42) and day 84
Arm/Group Title 10µg Dose FMP011 50µg Dose FMP011
Hide Arm/Group Description:

Falciparum Malaria Protein 11 with AS02A adjuvant

Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine

Falciparum Malaria Protein 11 with AS02A adjuvant

Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine

Overall Number of Participants Analyzed 5 13
Median (Full Range)
Unit of Measure: Titer units
Day 0
24.8
(21.4 to 171.2)
47.1
(18.5 to 220.2)
Day 28
1629.9
(82.3 to 2855.6)
834.8
(51.4 to 2207.3)
Day 42 (challenge day)
NA [1] 
(NA to NA)
29851.5
(10590.0 to 64250.0)
Day 84
NA [2] 
(NA to NA)
10378.5
(3397.0 to 49800.0)
[1]
Low dose group didn't participate in challenge (day 42)
[2]
Low dose group didn't participate in day 84
Time Frame Up to 6 months
Adverse Event Reporting Description

Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period

); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.

 
Arm/Group Title 10µg Dose FMP011 50µg Dose FMP011 Infecticvity Control (IC)
Hide Arm/Group Description

Falciparum Malaria Protein 11 with AS02A adjuvant

Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine

Falciparum Malaria Protein 11 with AS02A adjuvant

Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine

12 Subjects from the high dose group and 1 non immunized subject enrolled prior to challenge to serve as IC's for malaria sporozoite challenge.

1 infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report.

All-Cause Mortality
10µg Dose FMP011 50µg Dose FMP011 Infecticvity Control (IC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/13 (0.00%)      0/1 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
10µg Dose FMP011 50µg Dose FMP011 Infecticvity Control (IC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/13 (0.00%)      0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
10µg Dose FMP011 50µg Dose FMP011 Infecticvity Control (IC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/5 (100.00%)      13/13 (100.00%)      0/1 (0.00%)    
Blood and lymphatic system disorders       
Axilla lymphadenopathy * 1 [1]  1/5 (20.00%)  1 0/13 (0.00%)  0 0/1 (0.00%)  0
Axilla lymphadenopathy * 1 [2]  1/5 (20.00%)  1 0/13 (0.00%)  0 0/1 (0.00%)  0
Ear and labyrinth disorders       
Ringing in ears - bilateral * 1 [1]  0/5 (0.00%)  0 1/13 (7.69%)  1 0/1 (0.00%)  0
Ringing in ears - bilateral * 1 [3]  0/5 (0.00%)  0 1/13 (7.69%)  1 0/1 (0.00%)  0
Gastrointestinal disorders       
Nausea  1 [1]  0/5 (0.00%)  0 4/13 (30.77%)  4 0/1 (0.00%)  0
Nausea  1 [2]  0/5 (0.00%)  0 4/13 (30.77%)  4 0/1 (0.00%)  0
General disorders       
Local  1 [1]  5/5 (100.00%)  5 13/13 (100.00%)  13 0/1 (0.00%)  0
Pain  1 [1]  5/5 (100.00%)  5 13/13 (100.00%)  13 0/1 (0.00%)  0
Swelling  1 [1]  1/5 (20.00%)  1 2/13 (15.38%)  2 0/1 (0.00%)  0
Fever  1 [1]  1/5 (20.00%)  1 1/13 (7.69%)  1 0/1 (0.00%)  0
Malaise  1 [1]  2/5 (40.00%)  2 6/13 (46.15%)  6 0/1 (0.00%)  0
Fatigue  1 [1]  3/5 (60.00%)  3 6/13 (46.15%)  6 0/1 (0.00%)  0
Local  1 [3]  5/5 (100.00%)  5 13/13 (100.00%)  13 0/1 (0.00%)  0
Pain  1 [3]  5/5 (100.00%)  5 13/13 (100.00%)  13 0/1 (0.00%)  0
Swelling  1 [3]  1/5 (20.00%)  1 2/13 (15.38%)  2 0/1 (0.00%)  0
Fever  1 [3]  1/5 (20.00%)  1 0/13 (0.00%)  0 0/1 (0.00%)  0
Fatigue  1 [3]  1/5 (20.00%)  1 2/13 (15.38%)  2 0/1 (0.00%)  0
Local  1 [2]  5/5 (100.00%)  5 10/13 (76.92%)  10 0/1 (0.00%)  0
Pain  1 [2]  5/5 (100.00%)  5 9/13 (69.23%)  9 0/1 (0.00%)  0
Swelling  1 [2]  0/5 (0.00%)  0 1/13 (7.69%)  1 0/1 (0.00%)  0
Fever  1 [2]  1/5 (20.00%)  1 1/13 (7.69%)  1 0/1 (0.00%)  0
Malaise  1 [2]  2/5 (40.00%)  2 6/13 (46.15%)  6 0/1 (0.00%)  0
Fatigue  1 [2]  2/5 (40.00%)  2 6/13 (46.15%)  6 0/1 (0.00%)  0
Injury, poisoning and procedural complications       
Bruise at injection site * 1 [1]  0/5 (0.00%)  0 1/13 (7.69%)  1 0/1 (0.00%)  0
Bruise at injection site * 1 [2]  0/5 (0.00%)  0 1/13 (7.69%)  1 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Myalgia  1 [1]  2/5 (40.00%)  2 4/13 (30.77%)  4 0/1 (0.00%)  0
Myalgia  1 [3]  0/5 (0.00%)  0 1/13 (7.69%)  1 0/1 (0.00%)  0
Myalgia  1 [2]  2/5 (40.00%)  2 4/13 (30.77%)  4 0/1 (0.00%)  0
Chills * 1 [1]  0/5 (0.00%)  0 2/13 (15.38%)  2 0/1 (0.00%)  0
Nervous system disorders       
Headache  1 [1]  1/5 (20.00%)  1 5/13 (38.46%)  5 0/1 (0.00%)  0
Headache  1 [2]  1/5 (20.00%)  1 5/13 (38.46%)  5 0/1 (0.00%)  0
Vasovagal event * 1 [1]  0/5 (0.00%)  0 1/13 (7.69%)  1 0/1 (0.00%)  0
Vasovagal event * 1 [2]  0/5 (0.00%)  0 1/13 (7.69%)  1 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders       
Redness  1 [1]  3/5 (60.00%)  3 2/13 (15.38%)  2 0/1 (0.00%)  0
Redness  1 [3]  3/5 (60.00%)  3 2/13 (15.38%)  2 0/1 (0.00%)  0
Redness  1 [2]  0/5 (0.00%)  0 1/13 (7.69%)  1 0/1 (0.00%)  0
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
[1]
Any
[2]
Immunization 2
[3]
Immunization 1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: James F. Cummings, MD
Organization: Walter Reed Army Institute of Research
Phone: 301-319-9312
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00312702     History of Changes
Other Study ID Numbers: WRAIR 1249
HSRRB A-13732 ( Other Identifier: USAMRMC )
First Submitted: April 6, 2006
First Posted: April 10, 2006
Results First Submitted: December 9, 2016
Results First Posted: November 26, 2018
Last Update Posted: November 26, 2018