Trial Outcomes & Findings for A Study to Evaluate the Safety of AERAS-402 in Adults Recently Treated for Pulmonary TB (NCT NCT02414828)
NCT ID: NCT02414828
Last Updated: 2016-05-04
Results Overview
All adverse events will be summarized to examine the relationship between dose levels including number (percentage) of solicited and unsolicited adverse events (AEs), and number (percentage) of subjects with newly abnormal post-vaccination laboratory values based on predefined toxicity criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
182 days
Results posted on
2016-05-04
Participant Flow
Participant milestones
| Measure |
Placebo
Sterile buffer, Intramuscular (IM)
|
AERAS-402 3 x 10^8 vp
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^9 vp
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^10 vp
AERAS-402, 2 x IM, study days 0 and 42
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
20
|
31
|
|
Overall Study
COMPLETED
|
11
|
9
|
19
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Sterile buffer, Intramuscular (IM)
|
AERAS-402 3 x 10^8 vp
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^9 vp
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^10 vp
AERAS-402, 2 x IM, study days 0 and 42
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
2
|
Baseline Characteristics
A Study to Evaluate the Safety of AERAS-402 in Adults Recently Treated for Pulmonary TB
Baseline characteristics by cohort
| Measure |
Placebo
n=11 Participants
Sterile buffer, Intramuscular (IM)
|
AERAS-402 3 x 10^8 vp
n=10 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^9 vp
n=20 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^10 vp
n=31 Participants
AERAS-402, 2 x IM, study days 0 and 42
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18-30 years
|
6 years
n=5 Participants
|
5 years
n=7 Participants
|
11 years
n=5 Participants
|
20 years
n=4 Participants
|
42 years
n=21 Participants
|
|
Age, Customized
31-40 years
|
4 years
n=5 Participants
|
2 years
n=7 Participants
|
5 years
n=5 Participants
|
9 years
n=4 Participants
|
20 years
n=21 Participants
|
|
Age, Customized
41-45 years
|
1 years
n=5 Participants
|
3 years
n=7 Participants
|
4 years
n=5 Participants
|
2 years
n=4 Participants
|
10 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
22 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Coloured
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
21 participants
n=4 Participants
|
48 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
TB Treatment Status
On TB Treatment
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
16 participants
n=4 Participants
|
36 participants
n=21 Participants
|
|
TB Treatment Status
Post TB Treatment
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
15 participants
n=4 Participants
|
36 participants
n=21 Participants
|
|
History of Smoking
Yes - History of smoking
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
20 participants
n=4 Participants
|
51 participants
n=21 Participants
|
|
History of Smoking
No - History of Smoking
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
11 participants
n=4 Participants
|
21 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 182 daysAll adverse events will be summarized to examine the relationship between dose levels including number (percentage) of solicited and unsolicited adverse events (AEs), and number (percentage) of subjects with newly abnormal post-vaccination laboratory values based on predefined toxicity criteria.
Outcome measures
| Measure |
Placebo
n=11 Participants
Sterile Buffer, Intramuscular (IM)
|
AERAS-402 3 x 10^8 vp
n=10 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^9 vp
n=20 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^10 vp
n=31 Participants
AERAS-402, 2 x IM, study days 0 and 42
|
|---|---|---|---|---|
|
Number of Participants With Solicited and Unsolicited AEs
|
11 participants
|
10 participants
|
20 participants
|
30 participants
|
PRIMARY outcome
Timeframe: 182 daysPopulation: Subjects who were evaluated.
Maximum number of subjects with deterioration \>10% from baseline, at any time point. in forced expiratory volume in one second (FEV1)
Outcome measures
| Measure |
Placebo
n=5 Participants
Sterile Buffer, Intramuscular (IM)
|
AERAS-402 3 x 10^8 vp
n=10 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^9 vp
n=20 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^10 vp
n=29 Participants
AERAS-402, 2 x IM, study days 0 and 42
|
|---|---|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1)
On TB Treatment
|
1 participants
|
2 participants
|
0 participants
|
3 participants
|
|
Forced Expiratory Volume in One Second (FEV1)
Post TB Treatment
|
1 participants
|
3 participants
|
1 participants
|
5 participants
|
PRIMARY outcome
Timeframe: 182 daysPopulation: Subjects who were evaluated.
Maximum number of subjects with deterioration \>10% from baseline, at any time point, in forced vital capacity (FVC)
Outcome measures
| Measure |
Placebo
n=5 Participants
Sterile Buffer, Intramuscular (IM)
|
AERAS-402 3 x 10^8 vp
n=10 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^9 vp
n=20 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^10 vp
n=29 Participants
AERAS-402, 2 x IM, study days 0 and 42
|
|---|---|---|---|---|
|
Forced Vital Capacity (FVC)
Post TB Treatment
|
1 participants
|
3 participants
|
3 participants
|
4 participants
|
|
Forced Vital Capacity (FVC)
On TB Treatment
|
1 participants
|
2 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 182 DaysPopulation: Subjects who were evaluated.
Maximum number of subjects with deterioration \>15% from baseline, at any time point, in diffusing capacity of the lung for carbon monoxide (DLCO)
Outcome measures
| Measure |
Placebo
n=5 Participants
Sterile Buffer, Intramuscular (IM)
|
AERAS-402 3 x 10^8 vp
n=9 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^9 vp
n=20 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^10 vp
n=30 Participants
AERAS-402, 2 x IM, study days 0 and 42
|
|---|---|---|---|---|
|
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
On TB Treatment
|
1 participants
|
3 participants
|
0 participants
|
5 participants
|
|
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Post TB Treatment
|
1 participants
|
2 participants
|
2 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 42 days post doseAssessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.
Outcome measures
| Measure |
Placebo
n=5 Participants
Sterile Buffer, Intramuscular (IM)
|
AERAS-402 3 x 10^8 vp
n=5 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^9 vp
n=10 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^10 vp
n=16 Participants
AERAS-402, 2 x IM, study days 0 and 42
|
|---|---|---|---|---|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD4 Ag85A Day 0
|
0.025 percentage of T Cell response
Interval 0.025 to 0.168
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.062
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD4 Ag85A Day 42
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.056 percentage of T Cell response
Interval 0.025 to 0.112
|
0.057 percentage of T Cell response
Interval 0.025 to 0.176
|
0.061 percentage of T Cell response
Interval 0.025 to 0.121
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD4 Ag85A Day 84
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
NA percentage of T Cell response
No second dose given
|
NA percentage of T Cell response
No second dose given
|
0.072 percentage of T Cell response
Interval 0.025 to 0.228
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD4 Ag85B Day 0
|
0.025 percentage of T Cell response
Interval 0.025 to 0.097
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.085
|
0.025 percentage of T Cell response
Interval 0.025 to 0.093
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD4 Ag85B Day 42
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.112
|
0.052 percentage of T Cell response
Interval 0.025 to 0.175
|
0.082 percentage of T Cell response
Interval 0.025 to 0.16
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD4 Ag85B Day 84
|
0.233 percentage of T Cell response
Interval 0.164 to 0.303
|
NA percentage of T Cell response
No second dose given
|
NA percentage of T Cell response
No second dose given
|
0.489 percentage of T Cell response
Interval 0.153 to 0.789
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD4 TB10.4 Day 0
|
0.068 percentage of T Cell response
Interval 0.025 to 0.143
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.063 percentage of T Cell response
Interval 0.025 to 0.115
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD4 TB10.4 Day 42
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.223
|
0.053 percentage of T Cell response
Interval 0.025 to 0.064
|
0.025 percentage of T Cell response
Interval 0.025 to 0.084
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD4 TB10.4 Day 84
|
0.120 percentage of T Cell response
Interval 0.025 to 0.216
|
NA percentage of T Cell response
No second dose given
|
NA percentage of T Cell response
No second dose given
|
0.043 percentage of T Cell response
Interval 0.025 to 0.094
|
SECONDARY outcome
Timeframe: 42 days post doseAssessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.
Outcome measures
| Measure |
Placebo
n=5 Participants
Sterile Buffer, Intramuscular (IM)
|
AERAS-402 3 x 10^8 vp
n=5 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^9 vp
n=10 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^10 vp
n=16 Participants
AERAS-402, 2 x IM, study days 0 and 42
|
|---|---|---|---|---|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD8 Ag85B Day 84
|
0.080 percentage of T Cell response
Interval 0.025 to 0.135
|
NA percentage of T Cell response
No second dose given
|
NA percentage of T Cell response
No second dose given
|
0.571 percentage of T Cell response
Interval 0.364 to 2.239
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD8 Ag85A Day 0
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.21
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD8 Ag85A Day 42
|
0.025 percentage of T Cell response
Interval 0.025 to 0.07
|
0.085 percentage of T Cell response
Interval 0.025 to 0.258
|
0.301 percentage of T Cell response
Interval 0.081 to 2.049
|
0.076 percentage of T Cell response
Interval 0.025 to 0.584
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD8 Ag85A Day 84
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
NA percentage of T Cell response
No second dose given
|
NA percentage of T Cell response
No second dose given
|
0.169 percentage of T Cell response
Interval 0.025 to 2.34
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD8 Ag85B Day 0
|
0.025 percentage of T Cell response
Interval 0.025 to 0.066
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.481
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD8 Ag85B Day 42
|
0.025 percentage of T Cell response
Interval 0.025 to 0.083
|
0.089 percentage of T Cell response
Interval 0.025 to 0.223
|
0.310 percentage of T Cell response
Interval 0.104 to 2.352
|
0.125 percentage of T Cell response
Interval 0.058 to 0.332
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD8 TB10.4 Day 0
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.142
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD8 TB10.4 Day 42
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.068 percentage of T Cell response
Interval 0.025 to 0.078
|
0.025 percentage of T Cell response
Interval 0.025 to 0.533
|
0.223 percentage of T Cell response
Interval 0.025 to 0.505
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "on TB Treatment" Stratum
On TB Treatment CD8 TB10.4 Day 84
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
NA percentage of T Cell response
No second dose given
|
NA percentage of T Cell response
No second dose given
|
0.079 percentage of T Cell response
Interval 0.025 to 0.315
|
SECONDARY outcome
Timeframe: 42 days post doseAssessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.
Outcome measures
| Measure |
Placebo
n=6 Participants
Sterile Buffer, Intramuscular (IM)
|
AERAS-402 3 x 10^8 vp
n=5 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^9 vp
n=10 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^10 vp
n=15 Participants
AERAS-402, 2 x IM, study days 0 and 42
|
|---|---|---|---|---|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD4 Ag85A Day 0
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.067
|
0.025 percentage of T Cell response
Interval 0.025 to 0.06
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD4 Ag85A Day 42
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.056 percentage of T Cell response
Interval 0.025 to 0.092
|
0.089 percentage of T Cell response
Interval 0.025 to 0.148
|
0.057 percentage of T Cell response
Interval 0.025 to 0.13
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD4 Ag85B Day 0
|
0.025 percentage of T Cell response
Interval 0.025 to 0.29
|
0.025 percentage of T Cell response
Interval 0.025 to 0.057
|
0.025 percentage of T Cell response
Interval 0.025 to 0.064
|
0.025 percentage of T Cell response
Interval 0.025 to 0.059
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD4 Ag85B Day 84
|
0.487 percentage of T Cell response
Interval 0.025 to 0.657
|
NA percentage of T Cell response
No second dose given
|
NA percentage of T Cell response
No second dose given
|
0.547 percentage of T Cell response
Interval 0.36 to 0.849
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD4 TB10.4 Day 0
|
0.025 percentage of T Cell response
Interval 0.025 to 0.175
|
0.025 percentage of T Cell response
Interval 0.025 to 0.093
|
0.040 percentage of T Cell response
Interval 0.025 to 0.074
|
0.025 percentage of T Cell response
Interval 0.025 to 0.068
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD4 TB10.4 Day 42
|
0.025 percentage of T Cell response
Interval 0.025 to 0.163
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.089 percentage of T Cell response
Interval 0.025 to 0.174
|
0.025 percentage of T Cell response
Interval 0.025 to 0.099
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD4 TB10.4 Day 84
|
0.025 percentage of T Cell response
Interval 0.025 to 0.069
|
NA percentage of T Cell response
No second dose given
|
NA percentage of T Cell response
No second dose given
|
0.025 percentage of T Cell response
Interval 0.025 to 0.103
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD4 Ag85A Day 84
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
NA percentage of T Cell response
No second dose given
|
NA percentage of T Cell response
No second dose given
|
0.091 percentage of T Cell response
Interval 0.068 to 0.127
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD4 Ag85B Day 42
|
0.025 percentage of T Cell response
Interval 0.025 to 0.237
|
0.038 percentage of T Cell response
Interval 0.025 to 0.063
|
0.076 percentage of T Cell response
Interval 0.025 to 0.146
|
0.105 percentage of T Cell response
Interval 0.025 to 0.14
|
SECONDARY outcome
Timeframe: 42 days post doseAssessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.
Outcome measures
| Measure |
Placebo
n=6 Participants
Sterile Buffer, Intramuscular (IM)
|
AERAS-402 3 x 10^8 vp
n=5 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^9 vp
n=10 Participants
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^10 vp
n=15 Participants
AERAS-402, 2 x IM, study days 0 and 42
|
|---|---|---|---|---|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD8 Ag85A Day 0
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.057
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD8 Ag85A Day 42
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.584 percentage of T Cell response
Interval 0.025 to 2.205
|
0.083 percentage of T Cell response
Interval 0.025 to 2.037
|
0.054 percentage of T Cell response
Interval 0.025 to 0.279
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD8 Ag85A Day 84
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
NA percentage of T Cell response
No second dose given
|
NA percentage of T Cell response
No second dose given
|
0.400 percentage of T Cell response
Interval 0.125 to 0.71
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD8 Ag85B Day 42
|
0.025 percentage of T Cell response
Interval 0.025 to 0.193
|
0.439 percentage of T Cell response
Interval 0.025 to 1.83
|
0.206 percentage of T Cell response
Interval 0.025 to 1.945
|
0.169 percentage of T Cell response
Interval 0.025 to 0.475
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD8 Ag85B Day 84
|
0.109 percentage of T Cell response
Interval 0.025 to 0.393
|
NA percentage of T Cell response
No second dose given
|
NA percentage of T Cell response
No second dose given
|
0.673 percentage of T Cell response
Interval 0.338 to 1.206
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD8 TB10.4 Day 0
|
0.025 percentage of T Cell response
Interval 0.025 to 0.161
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD8 TB10.4 Day 42
|
0.025 percentage of T Cell response
Interval 0.025 to 0.094
|
0.025 percentage of T Cell response
Interval 0.025 to 0.417
|
0.025 percentage of T Cell response
Interval 0.025 to 0.285
|
0.025 percentage of T Cell response
Interval 0.025 to 0.074
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD8 TB10.4 Day 84
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
NA percentage of T Cell response
No second dose given
|
NA percentage of T Cell response
No second dose given
|
0.104 percentage of T Cell response
Interval 0.025 to 0.251
|
|
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "Post TB Treatment" Stratum
Post TB Treatment CD8 Ag85B Day 0
|
0.025 percentage of T Cell response
Interval 0.025 to 0.228
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
0.025 percentage of T Cell response
Interval 0.025 to 0.025
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
AERAS-402 3 x 10^8 vp
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
AERAS-402 3 x 10^9 vp
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
AERAS-402 3 x 10^10 vp
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=11 participants at risk
Sterile buffer, Intramuscular (IM)
|
AERAS-402 3 x 10^8 vp
n=10 participants at risk
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^9 vp
n=20 participants at risk
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^10 vp
n=31 participants at risk
AERAS-402, 2 x IM, study days 0 and 42
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/20
|
3.2%
1/31 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchioloalveolar carcinoma
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/20
|
0.00%
0/31
|
Other adverse events
| Measure |
Placebo
n=11 participants at risk
Sterile buffer, Intramuscular (IM)
|
AERAS-402 3 x 10^8 vp
n=10 participants at risk
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^9 vp
n=20 participants at risk
AERAS-402, 1 x IM, study day 0
|
AERAS-402 3 x 10^10 vp
n=31 participants at risk
AERAS-402, 2 x IM, study days 0 and 42
|
|---|---|---|---|---|
|
Infections and infestations
Bacteriuria
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/20
|
0.00%
0/31
|
|
Infections and infestations
Laryngitis
|
0.00%
0/11
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/20
|
0.00%
0/31
|
|
Infections and infestations
Rhinitis
|
0.00%
0/11
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
36.4%
4/11 • Number of events 6
|
20.0%
2/10 • Number of events 2
|
30.0%
6/20 • Number of events 6
|
19.4%
6/31 • Number of events 6
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/11
|
0.00%
0/10
|
10.0%
2/20 • Number of events 2
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Microcytosis
|
0.00%
0/11
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/11
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Metabolism and nutrition disorders
Polydipsia
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/20
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/11
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
0.00%
0/31
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/20
|
6.5%
2/31 • Number of events 2
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Number of events 3
|
0.00%
0/10
|
0.00%
0/20
|
29.0%
9/31 • Number of events 10
|
|
Eye disorders
Eye pain
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/20
|
3.2%
1/31 • Number of events 1
|
|
Vascular disorders
Labile blood pressure
|
0.00%
0/11
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/20
|
12.9%
4/31 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
10.0%
2/20 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/20
|
6.5%
2/31 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
1/11 • Number of events 3
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
16.1%
5/31 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.1%
1/11 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
0.00%
0/20
|
12.9%
4/31 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/20
|
0.00%
0/31
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/20
|
3.2%
1/31 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/20
|
9.7%
3/31 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Acne
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/20
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
9.1%
1/11 • Number of events 2
|
0.00%
0/10
|
0.00%
0/20
|
3.2%
1/31 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/20
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Erythema
|
18.2%
2/11 • Number of events 2
|
0.00%
0/10
|
0.00%
0/20
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/20
|
6.5%
2/31 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/11
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.2%
2/11 • Number of events 2
|
0.00%
0/10
|
0.00%
0/20
|
16.1%
5/31 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.2%
2/11 • Number of events 2
|
0.00%
0/10
|
0.00%
0/20
|
12.9%
4/31 • Number of events 4
|
|
Renal and urinary disorders
Bladder pain
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/20
|
0.00%
0/31
|
|
General disorders
Chest pain
|
27.3%
3/11 • Number of events 4
|
0.00%
0/10
|
10.0%
2/20 • Number of events 3
|
16.1%
5/31 • Number of events 7
|
|
General disorders
Fatigue
|
18.2%
2/11 • Number of events 2
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
16.1%
5/31 • Number of events 6
|
|
General disorders
Injection site discharge
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/20
|
0.00%
0/31
|
|
General disorders
Injection site erythema
|
45.5%
5/11 • Number of events 5
|
10.0%
1/10 • Number of events 1
|
35.0%
7/20 • Number of events 7
|
48.4%
15/31 • Number of events 18
|
|
General disorders
Injection site haematoma
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/20
|
0.00%
0/31
|
|
General disorders
Injection site pain
|
9.1%
1/11 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
35.0%
7/20 • Number of events 8
|
64.5%
20/31 • Number of events 32
|
|
General disorders
Injection site swelling
|
0.00%
0/11
|
0.00%
0/10
|
20.0%
4/20 • Number of events 4
|
16.1%
5/31 • Number of events 6
|
|
General disorders
Malaise
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
0.00%
0/31
|
|
General disorders
Pyrexia
|
0.00%
0/11
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
12.9%
4/31 • Number of events 4
|
|
General disorders
Vessel puncture site haematoma
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/20
|
0.00%
0/31
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11
|
0.00%
0/10
|
10.0%
2/20 • Number of events 2
|
6.5%
2/31 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
1/11 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
10.0%
2/20 • Number of events 2
|
9.7%
3/31 • Number of events 3
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/11
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
0.00%
0/31
|
|
Investigations
Blood creatine phosphokinase increased
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/20
|
6.5%
2/31 • Number of events 2
|
|
Investigations
Blood pressure diastolic increased
|
18.2%
2/11 • Number of events 2
|
10.0%
1/10 • Number of events 2
|
15.0%
3/20 • Number of events 5
|
6.5%
2/31 • Number of events 2
|
|
Investigations
Blood pressure systolic decreased
|
9.1%
1/11 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/20
|
0.00%
0/31
|
|
Investigations
Blood pressure systolic increased
|
18.2%
2/11 • Number of events 2
|
30.0%
3/10 • Number of events 3
|
5.0%
1/20 • Number of events 1
|
9.7%
3/31 • Number of events 3
|
|
Investigations
Blood urine present
|
18.2%
2/11 • Number of events 2
|
0.00%
0/10
|
0.00%
0/20
|
29.0%
9/31 • Number of events 11
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
18.2%
2/11 • Number of events 2
|
0.00%
0/10
|
0.00%
0/20
|
45.2%
14/31 • Number of events 15
|
|
Investigations
Crystal urine present
|
9.1%
1/11 • Number of events 2
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
|
Investigations
False positive tuberculosis test
|
0.00%
0/11
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
0.00%
0/31
|
|
Investigations
Forced expiratory volume decreased
|
18.2%
2/11 • Number of events 3
|
0.00%
0/10
|
0.00%
0/20
|
19.4%
6/31 • Number of events 9
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/11
|
0.00%
0/10
|
10.0%
2/20 • Number of events 2
|
19.4%
6/31 • Number of events 6
|
|
Investigations
Glucose urine
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
15.0%
3/20 • Number of events 3
|
9.7%
3/31 • Number of events 3
|
|
Investigations
Haemoglobin decreased
|
18.2%
2/11 • Number of events 2
|
30.0%
3/10 • Number of events 3
|
20.0%
4/20 • Number of events 4
|
29.0%
9/31 • Number of events 12
|
|
Investigations
Heart rate decreased
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
9.7%
3/31 • Number of events 3
|
|
Investigations
Heart rate increased
|
36.4%
4/11 • Number of events 5
|
10.0%
1/10 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
19.4%
6/31 • Number of events 8
|
|
Investigations
Lymphocyte count decreased
|
9.1%
1/11 • Number of events 2
|
0.00%
0/10
|
0.00%
0/20
|
12.9%
4/31 • Number of events 4
|
|
Investigations
Neutrophil count decreased
|
18.2%
2/11 • Number of events 2
|
10.0%
1/10 • Number of events 2
|
15.0%
3/20 • Number of events 4
|
19.4%
6/31 • Number of events 7
|
|
Investigations
Neutrophil count increased
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/20
|
16.1%
5/31 • Number of events 5
|
|
Investigations
Protein urine
|
54.5%
6/11 • Number of events 6
|
40.0%
4/10 • Number of events 4
|
30.0%
6/20 • Number of events 6
|
45.2%
14/31 • Number of events 20
|
|
Investigations
Red blood cell hypochromic morphology present
|
0.00%
0/11
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
0.00%
0/31
|
|
Investigations
Red blood cell morphology abnormal
|
0.00%
0/11
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
0.00%
0/31
|
|
Investigations
Red blood cells urine
|
27.3%
3/11 • Number of events 3
|
0.00%
0/10
|
20.0%
4/20 • Number of events 4
|
32.3%
10/31 • Number of events 15
|
|
Investigations
Urine leukocyte esterase positive
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/20
|
25.8%
8/31 • Number of events 9
|
|
Investigations
Vital capacity decreased
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/20
|
16.1%
5/31 • Number of events 5
|
|
Investigations
Weight decreased
|
0.00%
0/11
|
0.00%
0/10
|
10.0%
2/20 • Number of events 2
|
0.00%
0/31
|
|
Investigations
White blood cell count decreased
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/20
|
6.5%
2/31 • Number of events 3
|
|
Investigations
White blood cell count increased
|
0.00%
0/11
|
20.0%
2/10 • Number of events 2
|
0.00%
0/20
|
9.7%
3/31 • Number of events 3
|
|
Investigations
White blood cells urine positive
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
19.4%
6/31 • Number of events 9
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/11
|
0.00%
0/10
|
5.0%
1/20 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/20
|
3.2%
1/31 • Number of events 2
|
|
Social circumstances
Physical assault
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/20
|
0.00%
0/31
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place