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Staged Phase I/II Hepatitis C Prophylactic Vaccine

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: NCT01436357
Recruitment Status : Completed
First Posted : September 19, 2011
Results First Posted : July 22, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Hepatitis C
Interventions Biological: AdCh3NSmut1
Biological: MVA-NSmut
Other: Placebo
Enrollment 548
Recruitment Details People who are actively injecting drugs who are at high risk for HCV infection, negative for HCV antibodies and HCV RNA at screening, were recruited at 3 clinical sites experienced in recruiting and retaining people who inject drugs in prospective studies. Participants were enrolled between 19MAR2012 and 28OCT2016.
Pre-assignment Details  
Arm/Group Title AdCh3NSmut1 and MVA-NSmut Sodium Chloride Placebo
Hide Arm/Group Description One dose of AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10^8 plaque forming units (pfu). Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Period Title: Overall Study
Started 274 274
Stage 1 49 48
Stage 2 225 226
Completed 152 146
Not Completed 122 128
Reason Not Completed
Death             5             1
Enrolled but not vaccinated             1             1
Incarceration             18             20
Lost to Follow-up             67             61
Protocol Violation             1             0
Withdrawal by Subject             26             38
Physician Decision             3             4
Moved out of area             1             2
Subject in rehab             0             1
Arm/Group Title AdCh3NSmut1 and MVA-NSmut Sodium Chloride Placebo Total
Hide Arm/Group Description One dose of AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10^8 plaque forming units (pfu). Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56. Total of all reporting groups
Overall Number of Baseline Participants 274 274 548
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants 274 participants 548 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
274
 100.0%
274
 100.0%
548
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 274 participants 274 participants 548 participants
31.3  (7.3) 30.4  (7.2) 30.9  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants 274 participants 548 participants
Female
60
  21.9%
62
  22.6%
122
  22.3%
Male
214
  78.1%
212
  77.4%
426
  77.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants 274 participants 548 participants
Hispanic or Latino
40
  14.6%
39
  14.2%
79
  14.4%
Not Hispanic or Latino
234
  85.4%
235
  85.8%
469
  85.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants 274 participants 548 participants
American Indian or Alaska Native
7
   2.6%
2
   0.7%
9
   1.6%
Asian
2
   0.7%
4
   1.5%
6
   1.1%
Native Hawaiian or Other Pacific Islander
2
   0.7%
0
   0.0%
2
   0.4%
Black or African American
62
  22.6%
51
  18.6%
113
  20.6%
White
159
  58.0%
175
  63.9%
334
  60.9%
More than one race
33
  12.0%
30
  10.9%
63
  11.5%
Unknown or Not Reported
9
   3.3%
12
   4.4%
21
   3.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 274 participants 274 participants 548 participants
274 274 548
IL28B Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants 274 participants 548 participants
CC
111
  40.5%
111
  40.5%
222
  40.5%
CT/TT
163
  59.5%
163
  59.5%
326
  59.5%
[1]
Measure Description: The IL28B gene is involved in the immune response to certain viruses, including hepatitis C. There are three IL28B subtypes (called genotypes): CC, CT, and TT. People with the CC genotype have a more potent immune response to HCV infection than people with the CT or TT genotypes (called non-CC genotypes). This immune response makes people who have a CC genotype more likely to clear HCV without treatment (called spontaneous viral clearance), within months of becoming infected. Given the impact of this gene, subjects were stratified based on having CC on non-CC genotypes.
1.Primary Outcome
Title Number of Participants With Chronic Hepatitis C Virus (HCV) Infection at 6 Months
Hide Description Chronic hepatitis C virus (HCV) infection was defined by persistent viremia over a period of 6 months after initial detection of primary infection.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized are included as treated (one participant randomized to placebo received vaccine) with the following censoring criteria applied: did not receive both vaccinations, HCV infected at baseline, did not have sufficient follow-up to be evaluable for efficacy, or had major protocol deviations compromising the assessment of vaccine efficacy.
Arm/Group Title AdCh3NSmut1 and MVA-NSmut Sodium Chloride Placebo
Hide Arm/Group Description:
One dose of AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10^8 plaque forming units (pfu).
Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Overall Number of Participants Analyzed 275 273
Measure Type: Count of Participants
Unit of Measure: Participants
14
   5.1%
14
   5.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AdCh3NSmut1 and MVA-NSmut, Sodium Chloride Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.317
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.529
Confidence Interval (2-Sided) 95%
0.661 to 3.535
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) at 1 Month After First Vaccination
Hide Description Blood was collected at baseline and 1 month after each vaccination for assessment of alanine transferase (ALT) (SGPT), creatinine, hemoglobin, platelets, and white blood cells (WBC). A laboratory AE was defined for ALT as greater than 1.25 times the upper limit of normal. A laboratory AE was defined for creatinine as greater than or equal to 1.2 times the upper limit of normal (as appropriate for age and sex). A laboratory AE was defined for hemoglobin as less that or equal to 12.4 g/dl for males and less than or equal to 10.8 g/dl for females. A laboratory AE was defined for platelets as less than or equal to 117,000 per cumm. A laboratory AE was defined for WBC as less than or equal to 2.9 thou/mcl or greater than or equal to 11.9 thou/mcl.
Time Frame 1 month after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population includes all participants with blood collected at the timepoint summarized. Participants are analyzed as treated.
Arm/Group Title AdCh3NSmut1 and MVA-NSmut Sodium Chloride Placebo
Hide Arm/Group Description:
One dose of AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10^8 plaque forming units (pfu).
Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Overall Number of Participants Analyzed 274 272
Measure Type: Count of Participants
Unit of Measure: Participants
70
  25.5%
48
  17.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AdCh3NSmut1 and MVA-NSmut, Sodium Chloride Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.01 to 0.16
Estimation Comments [Not Specified]
3.Primary Outcome
Title Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) at 1 Month After Second Vaccination
Hide Description Blood was collected at baseline and 1 month after each vaccination for assessment of alanine transferase (ALT) (SGPT), creatinine, hemoglobin, platelets, and white blood cells (WBC). A laboratory AE was defined for ALT as greater than 1.25 times the upper limit of normal. A laboratory AE was defined for creatinine as greater than or equal to 1.2 times the upper limit of normal (as appropriate for age and sex). A laboratory AE was defined for hemoglobin as less that or equal to 12.4 g/dl for males and less than or equal to 10.8 g/dl for females. A laboratory AE was defined for platelets as less than or equal to 117,000 per cumm. A laboratory AE was defined for WBC as less than or equal to 2.9 thou/mcl or greater than or equal to 11.9 thou/mcl.
Time Frame 1 month after second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population includes all participants with blood collected at the timepoint summarized. Participants are analyzed as treated.
Arm/Group Title AdCh3NSmut1 and MVA-NSmut Sodium Chloride Placebo
Hide Arm/Group Description:
One dose of AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10^8 plaque forming units (pfu).
Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Overall Number of Participants Analyzed 228 227
Measure Type: Count of Participants
Unit of Measure: Participants
73
  32.0%
49
  21.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AdCh3NSmut1 and MVA-NSmut, Sodium Chloride Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
0.01 to 0.20
Estimation Comments [Not Specified]
4.Primary Outcome
Title Number of Participants With Severe Local and/or Systemic Solicited Reactogenicity Signs and Symptoms in the 8 Days (Day 0-7) After First Vaccination
Hide Description Participants recorded temperature and the presence and intensity of post-vaccination reactogenicity events daily on an 8-day memory aid. Local solicited reactogenicity events included pain, tenderness, erythema, induration and warmth at the injection site. Systemic solicited reactogenicity events included fever, chills, arthralgia/joint pain, malaise/fatigue, myalgia/body aches, headache, nausea, vomiting, abdominal pain. Severe was defined as "events interrupt a subject's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually incapacitating." Measured erythema and induration of >50 mm and oral temperature >40.0 degrees Celsius were considered severe.
Time Frame 7 days after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population includes all participants receiving the vaccination for whom data were available. Participants are analyzed as treated.
Arm/Group Title AdCh3NSmut1 and MVA-NSmut Sodium Chloride Placebo
Hide Arm/Group Description:
One dose of AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10^8 plaque forming units (pfu).
Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Overall Number of Participants Analyzed 274 272
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AdCh3NSmut1 and MVA-NSmut, Sodium Chloride Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0
Estimation Comments [Not Specified]
5.Primary Outcome
Title Occurrence of Vaccine-related Serious Adverse Events (SAEs) From the Time of First Vaccination Through the Entire Study Period
Hide Description The occurrence of SAEs was assessed at every study visit. The occurrence of SAEs may also have come to the attention of the investigator by secondary contacts of the participant when they did not present for study visits. Relationship to vaccine was assessed by the site investigator.
Time Frame Day 0 to 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population excludes 1 participant who was not vaccinated. Participants are analyzed as treated.
Arm/Group Title AdCh3NSmut1 and MVA-NSmut Sodium Chloride Placebo
Hide Arm/Group Description:
One dose of AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10^8 plaque forming units (pfu).
Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Overall Number of Participants Analyzed 274 272
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Number of Participants With Severe Local and/or Systemic Solicited Reactogenicity Signs and Symptoms in the 8 Days (Day 0-7) After Second Vaccination
Hide Description Participants recorded temperature and the presence and intensity of post-vaccination reactogenicity events daily on an 8-day memory aid. Local solicited reactogenicity events included pain, tenderness, erythema, induration and warmth at the injection site. Systemic solicited reactogenicity events included fever, chills, arthralgia/joint pain, malaise/fatigue, myalgia/body aches, headache, nausea, vomiting, abdominal pain. Severe was defined as "events interrupt a subject's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually incapacitating." Measured erythema and induration of >50 mm and oral temperature >40.0 degrees Celsius were considered severe.
Time Frame 7 days after second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population includes all participants receiving the vaccination for whom data were available. Participants are analyzed as treated.
Arm/Group Title AdCh3NSmut1 and MVA-NSmut Sodium Chloride Placebo
Hide Arm/Group Description:
One dose of AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10^8 plaque forming units (pfu).
Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Overall Number of Participants Analyzed 228 227
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.9%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AdCh3NSmut1 and MVA-NSmut, Sodium Chloride Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.499
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.08 to 0.10
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Positive Cell Mediated Immune Response
Hide Description Cell mediated immune response was measured by interferon gamma (IFN-gamma) production by T-cells against each of the six HCV genotype 1b peptide pools in the vaccine. Positivity was defined as i) more than 48 spot forming cells per million PBMC; and ii) at least three times the mean background spots per million PBMC found in ELISpot wells containing cells and peptide diluent (DMSO). A participant was considered a responder if a positive response to at least one in 6 mixtures (pools) of peptides was detected.
Time Frame Within 14 days after the last vaccination (Day 56)
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this outcome included all participants who received both vaccinations and had immunogenicity data available. Participants are analyzed as treated. Data collected post-HCV infection were excluded from this analysis.
Arm/Group Title AdCh3NSmut1 and MVA-NSmut Sodium Chloride Placebo
Hide Arm/Group Description:
One dose of AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10^8 plaque forming units (pfu).
Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
Overall Number of Participants Analyzed 125 122
Measure Type: Count of Participants
Unit of Measure: Participants
97
  77.6%
4
   3.3%
Time Frame Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE’s were collected.
Adverse Event Reporting Description For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
 
Arm/Group Title AdCh3NSmut1 and MVA-NSmut Sodium Chloride Placebo
Hide Arm/Group Description One dose of AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10^8 plaque forming units (pfu). Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56.
All-Cause Mortality
AdCh3NSmut1 and MVA-NSmut Sodium Chloride Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   5/274 (1.82%)      2/272 (0.74%)    
Hide Serious Adverse Events
AdCh3NSmut1 and MVA-NSmut Sodium Chloride Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/274 (14.60%)      25/272 (9.19%)    
Gastrointestinal disorders     
Colitis * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Pancreatitis * 1  2/274 (0.73%)  2 0/272 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis Acute * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Hepatitis * 1  1/274 (0.36%)  1 0/272 (0.00%)  0
Liver Injury * 1  2/274 (0.73%)  2 0/272 (0.00%)  0
Infections and infestations     
Abscess * 1  1/274 (0.36%)  1 1/272 (0.37%)  1
Abscess Limb * 1  2/274 (0.73%)  2 0/272 (0.00%)  0
Abscess Neck * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Arthritis Bacterial * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Bursitis Infective * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Cellulitis * 1  4/274 (1.46%)  4 2/272 (0.74%)  2
Clostridium Difficile Colitis * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Endocarditis * 1  2/274 (0.73%)  2 0/272 (0.00%)  0
Gangrene * 1  1/274 (0.36%)  1 0/272 (0.00%)  0
HIV Infection * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Osteomyelitis * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Pneumonia * 1  1/274 (0.36%)  1 2/272 (0.74%)  2
Psoas Abscess * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Staphylococcal Bacteraemia * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Subcutaneous Abscess * 1  1/274 (0.36%)  1 0/272 (0.00%)  0
Tooth Abscess * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Urosepsis * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Injury, poisoning and procedural complications     
Facial Bones Fracture * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Head Injury * 1  1/274 (0.36%)  1 1/272 (0.37%)  1
Hip Fracture * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Injury * 1  1/274 (0.36%)  1 0/272 (0.00%)  0
Lower Limb Fracture * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Multiple Fractures * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Overdose * 1  5/274 (1.82%)  5 0/272 (0.00%)  0
Subdural Haematoma * 1  1/274 (0.36%)  1 0/272 (0.00%)  0
Toxicity To Various Agents * 1  1/274 (0.36%)  1 1/272 (0.37%)  1
Traumatic Liver Injury * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Uterine Rupture * 1  1/274 (0.36%)  1 0/272 (0.00%)  0
Investigations     
Foetal Monitoring * 1  1/274 (0.36%)  1 0/272 (0.00%)  0
Metabolism and nutrition disorders     
Type 1 Diabetes Mellitus * 1  1/274 (0.36%)  1 0/272 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Compartment Syndrome * 1  1/274 (0.36%)  1 0/272 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Transitional Cell Carcinoma * 1  1/274 (0.36%)  1 0/272 (0.00%)  0
Nervous system disorders     
Hypoxic-Ischaemic Encephalopathy * 1  1/274 (0.36%)  1 0/272 (0.00%)  0
Seizure * 1  1/274 (0.36%)  1 1/272 (0.37%)  1
Pregnancy, puerperium and perinatal conditions     
Foetal Death * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Psychiatric disorders     
Affective Disorder * 1  1/274 (0.36%)  1 0/272 (0.00%)  0
Completed Suicide * 1  2/274 (0.73%)  2 1/272 (0.37%)  1
Depression * 1  1/274 (0.36%)  1 0/272 (0.00%)  0
Mental Status Changes * 1  0/274 (0.00%)  0 1/272 (0.37%)  1
Psychotic Disorder * 1  3/274 (1.09%)  3 1/272 (0.37%)  1
Schizoaffective Disorder * 1  1/274 (0.36%)  1 0/272 (0.00%)  0
Suicidal Ideation * 1  2/274 (0.73%)  2 1/272 (0.37%)  1
Suicide Attempt * 1  2/274 (0.73%)  2 2/272 (0.74%)  2
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/274 (0.36%)  1 0/272 (0.00%)  0
Pulmonary Embolism * 1  1/274 (0.36%)  1 0/272 (0.00%)  0
1
Term from vocabulary, MedDRA (20.1)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AdCh3NSmut1 and MVA-NSmut Sodium Chloride Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   229/274 (83.58%)      172/272 (63.24%)    
Gastrointestinal disorders     
Nausea  1  51/274 (18.61%)  64 48/272 (17.65%)  54
Vomiting  1  26/274 (9.49%)  28 26/272 (9.56%)  29
Abdominal pain  1  45/274 (16.42%)  57 34/272 (12.50%)  38
General disorders     
Injection site pain  1 [1]  140/274 (51.09%)  176 21/272 (7.72%)  21
Injection site pain  1 [2]  178/274 (64.96%)  247 43/272 (15.81%)  46
Injection site warmth  1  52/274 (18.98%)  62 19/272 (6.99%)  21
Injection site erythema  1  95/274 (34.67%)  126 61/272 (22.43%)  77
Injection site induration  1  79/274 (28.83%)  98 29/272 (10.66%)  33
Malaise  1  114/274 (41.61%)  147 99/272 (36.40%)  120
Chills  1  51/274 (18.61%)  60 35/272 (12.87%)  40
Investigations     
Body temperature increase  1  28/274 (10.22%)  29 8/272 (2.94%)  9
Aspartate aminotransferase increased * 1  29/274 (10.58%)  30 29/272 (10.66%)  31
Blood alkaline phosphatase increased  1  15/274 (5.47%)  15 11/272 (4.04%)  11
Musculoskeletal and connective tissue disorders     
Myalgia  1  112/274 (40.88%)  138 69/272 (25.37%)  80
Arthralgia  1  63/274 (22.99%)  78 37/272 (13.60%)  45
Nervous system disorders     
Headache  1  95/274 (34.67%)  114 64/272 (23.53%)  74
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
[1]
Solicited as "Pain"
[2]
Solicited as "Tenderness"
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Kimberly Page, Ph.D., M.P.H. and Andrea Cox, M.D., Ph.D.
Organization: University of New Mexico and Johns Hopkins University
Phone: 505-272-2520, 410-502-2715
EMail: pagek@salud.unm.edu, acox@jhmi.edu
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01436357    
Other Study ID Numbers: 10-0069
First Submitted: September 15, 2011
First Posted: September 19, 2011
Results First Submitted: May 24, 2019
Results First Posted: July 22, 2019
Last Update Posted: November 19, 2019