Tuberculosis
Conditions
Brief summary
This was a double-blind, randomized, placebo-controlled dose-escalation study in adults recently treated for pulmonary TB. The dose of AERAS-402 increased in successive dose groups. Enrollment into a dose group was sequential. Enrollees were stratified based on time from the start of TB treatment. The on-TB-treatment stratum started TB treatment between 1 and 4 months (30 to 120 calendar days) prior to Study Day 0. The post-TB-treatment stratum started TB treatment at least 12 months (360 calendar days) prior to Study Day 0. Subjects were randomized to receive a placebo or AERAS-402 vaccine. In Dose Groups 1 and 2, subjects were randomized to receive a single injection of AERAS-402 or placebo. Dose Group 3 subjects were randomized to receive two injections on study day 0 and study day 42 of AERAS-402 or placebo.
Detailed description
A total of 72 subjects were randomized into the study. Subjects were stratified, based on time from the start of TB treatment, into the 'on-TB-treatment' stratum (TB treatment started between 1 and 4 months prior to Study Day 0) or the 'post-TB-treatment' stratum (TB treatment started at least 12 months before Study Day 0). In the on-TB-treatment stratum, 36 subjects were randomized to receive AERAS-402 or placebo as follows: 1 or 2 doses of placebo (N=5); 1 dose of AERAS-402 at 3 x 10\^8 vp (N=5) or 3 x 10\^9 vp (N=10), or 2 doses of AERAS-402 at 3 x 10\^10 vp (N=16). In the post-TB-treatment stratum, 36 subjects were randomized to receive AERAS-402 or placebo as follows: 1 or 2 doses of placebo (N=6); 1 dose of AERAS-402 at 3 x 10\^8 vp (N=5) or 3 x 109 vp (N=10), or 2 doses of AERAS-402 at 3 x 10\^10 vp (N=15).
Interventions
BIOLOGICALPlacebo
This is the identical buffer solution in which AERAS-402 is formulated. The placebo (1.0 mL volume) was administered by intramuscular (IM) injection to the deltoid area on Study Day 0 for groups 1 and 2 and Study Day 0 and 42 for group 3.
BIOLOGICALAERAS-402 3 x 10^8 vp
AERAS-402 was administered by single intramuscular (IM) injection to the deltoid area on Study Day 0
BIOLOGICALAERAS-402 3 x 10^9 vp
AERAS-402 was administered by single intramuscular (IM) injection to the deltoid area on Study Day 0
BIOLOGICALAERAS-402 3 x 10^10 vp
AERAS-402 was administered by intramuscular (IM) injection to the deltoid area on Study Days 0 and 42.
Sponsors
Crucell Holland BV
Aeras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is male or female. 2. Is age 18 through 45 years on Study Day 0. 3. Has completed the written informed consent process. 4. Has a history of pulmonary tuberculosis diagnosed by either a sputum smear positive for acid-fast bacilli (AFB) or a sputum culture positive for Mtb. 5. Has initiated effective chemotherapy for tuberculosis between one month (30 days) and four months (120 days) before Study Day 0, with improvement in clinical signs and/or symptoms of disease, OR: has initiated effective chemotherapy for tuberculosis at least 12 months (360 days) before Study Day 0, and is considered cured. 6. For subjects currently receiving chemotherapy for tuberculosis they must have been fully compliant with previously prescribed tuberculosis therapy and agree to complete currently prescribed tuberculosis therapy. 7. Agrees to avoid elective surgery for the full duration of the study. 8. For female subjects: agrees to avoid pregnancy for the full duration of the study. 9. Agrees to stay in contact with the study site for the full duration of the study, providing updated contact information as necessary, and has no current plans to move from the study area during the duration of the study. 10. Has completed simultaneous enrollment in Aeras Vaccine Development Registry Protocol.
Exclusion criteria
1. Fever ≥37.5°C. 2. Evidence of a new acute illness that may compromise the safety of the subject in the study. 3. Evidence of any significant active infection other than tuberculosis. 4. Evidence of central nervous system tuberculosis or pleural tuberculosis. 5. Previous medical history that may compromise the safety of the subject in the study, including but not limited to: severe impairment of pulmonary function from tuberculosis infection or other pulmonary disease; chronic illness with signs of cardiac or renal failure; suspected progressive neurological disease; or uncontrolled epilepsy or infantile spasms. 6. Evidence of any systemic disease or any acute or chronic illness that may interfere with the evaluation of the safety of the vaccine. 7. History or laboratory evidence of any past, present or future possible immunodeficiency state, including but not limited to any laboratory indication of HIV-1 infection. 8. History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine. 9. Received any investigational drug therapy or vaccine within 182 days before the first dose of study vaccine in this protocol. 10. Received any adenovirus-based vaccine previously. 11. For female subjects: Currently pregnant, lactating/nursing, or a positive serum or urine βhCG 12. Severe anemia, defined as a hemoglobin less than 10 g/dL or a hematocrit less than 30 percent. 13. Urine toxicology screen positive for opiates, cocaine, or amphetamines. 14. Anal intercourse with another man at least one time (with or without condoms). 15. Exchange of goods, money, services or drugs for sex. 16. Use of intravenous drugs. 17. Sexual intercourse or genital contact within the last 12 months with a known HIV positive individual. 18. Vaginal intercourse within the last 12 months without use of a condom with a known user of intravenous drugs. 19. Oral to genital contact within the last 12 months with a known user of intravenous drugs. 20. Vaginal intercourse within the last 12 months without use of a condom with an individual known to have more than one sex partner. 21. Oral to genital contact within the last 12 months with an individual known to have more than one sex partner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | 182 Days | Maximum number of subjects with deterioration \>15% from baseline, at any time point, in diffusing capacity of the lung for carbon monoxide (DLCO) |
| Number of Participants With Solicited and Unsolicited AEs | 182 days | 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. |
| Forced Expiratory Volume in One Second (FEV1) | 182 days | Maximum number of subjects with deterioration \>10% from baseline, at any time point. in forced expiratory volume in one second (FEV1) |
| Forced Vital Capacity (FVC) | 182 days | Maximum number of subjects with deterioration \>10% from baseline, at any time point, in forced vital capacity (FVC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the on TB Treatment Stratum | 42 days post dose | Assessment 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. |
| Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the on TB Treatment Stratum | 42 days post dose | Assessment 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. |
| Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the Post TB Treatment Stratum | 42 days post dose | Assessment 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. |
| Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the Post TB Treatment Stratum | 42 days post dose | Assessment 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. |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Sterile buffer, Intramuscular (IM) | 11 |
| AERAS-402 3 x 10^8 vp AERAS-402, 1 x IM, study day 0 | 10 |
| AERAS-402 3 x 10^9 vp AERAS-402, 1 x IM, study day 0 | 20 |
| AERAS-402 3 x 10^10 vp AERAS-402, 2 x IM, study days 0 and 42 | 31 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Placebo | AERAS-402 3 x 10^8 vp | AERAS-402 3 x 10^9 vp | AERAS-402 3 x 10^10 vp |
|---|---|---|---|---|---|
| Age, Customized 18-30 years | 42 years | 6 years | 5 years | 11 years | 20 years |
| Age, Customized 31-40 years | 20 years | 4 years | 2 years | 5 years | 9 years |
| Age, Customized 41-45 years | 10 years | 1 years | 3 years | 4 years | 2 years |
| History of Smoking No - History of Smoking | 21 participants | 0 participants | 4 participants | 6 participants | 11 participants |
| History of Smoking Yes - History of smoking | 51 participants | 11 participants | 6 participants | 14 participants | 20 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black | 22 participants | 1 participants | 3 participants | 9 participants | 9 participants |
| Race/Ethnicity, Customized Coloured | 48 participants | 10 participants | 6 participants | 11 participants | 21 participants |
| Race/Ethnicity, Customized White | 2 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Sex: Female, Male Female | 41 Participants | 5 Participants | 6 Participants | 14 Participants | 16 Participants |
| Sex: Female, Male Male | 31 Participants | 6 Participants | 4 Participants | 6 Participants | 15 Participants |
| TB Treatment Status On TB Treatment | 36 participants | 5 participants | 5 participants | 10 participants | 16 participants |
| TB Treatment Status Post TB Treatment | 36 participants | 6 participants | 5 participants | 10 participants | 15 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 11 | 10 / 10 | 20 / 20 | 30 / 31 |
| serious Total, serious adverse events | 0 / 11 | 1 / 10 | 0 / 20 | 1 / 31 |
Outcome results
Primary
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Maximum number of subjects with deterioration \>15% from baseline, at any time point, in diffusing capacity of the lung for carbon monoxide (DLCO)
Time frame: 182 Days
Population: Subjects who were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | On TB Treatment | 1 participants |
| Placebo | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | Post TB Treatment | 1 participants |
| AERAS-402 3 x 10^8 vp | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | Post TB Treatment | 2 participants |
| AERAS-402 3 x 10^8 vp | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | On TB Treatment | 3 participants |
| AERAS-402 3 x 10^9 vp | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | On TB Treatment | 0 participants |
| AERAS-402 3 x 10^9 vp | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | Post TB Treatment | 2 participants |
| AERAS-402 3 x 10^10 vp | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | On TB Treatment | 5 participants |
| AERAS-402 3 x 10^10 vp | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | Post TB Treatment | 7 participants |
Primary
Forced Expiratory Volume in One Second (FEV1)
Maximum number of subjects with deterioration \>10% from baseline, at any time point. in forced expiratory volume in one second (FEV1)
Time frame: 182 days
Population: Subjects who were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Forced Expiratory Volume in One Second (FEV1) | Post TB Treatment | 1 participants |
| Placebo | Forced Expiratory Volume in One Second (FEV1) | On TB Treatment | 1 participants |
| AERAS-402 3 x 10^8 vp | Forced Expiratory Volume in One Second (FEV1) | Post TB Treatment | 3 participants |
| AERAS-402 3 x 10^8 vp | Forced Expiratory Volume in One Second (FEV1) | On TB Treatment | 2 participants |
| AERAS-402 3 x 10^9 vp | Forced Expiratory Volume in One Second (FEV1) | On TB Treatment | 0 participants |
| AERAS-402 3 x 10^9 vp | Forced Expiratory Volume in One Second (FEV1) | Post TB Treatment | 1 participants |
| AERAS-402 3 x 10^10 vp | Forced Expiratory Volume in One Second (FEV1) | Post TB Treatment | 5 participants |
| AERAS-402 3 x 10^10 vp | Forced Expiratory Volume in One Second (FEV1) | On TB Treatment | 3 participants |
Primary
Forced Vital Capacity (FVC)
Maximum number of subjects with deterioration \>10% from baseline, at any time point, in forced vital capacity (FVC)
Time frame: 182 days
Population: Subjects who were evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Forced Vital Capacity (FVC) | On TB Treatment | 1 participants |
| Placebo | Forced Vital Capacity (FVC) | Post TB Treatment | 1 participants |
| AERAS-402 3 x 10^8 vp | Forced Vital Capacity (FVC) | On TB Treatment | 2 participants |
| AERAS-402 3 x 10^8 vp | Forced Vital Capacity (FVC) | Post TB Treatment | 3 participants |
| AERAS-402 3 x 10^9 vp | Forced Vital Capacity (FVC) | On TB Treatment | 0 participants |
| AERAS-402 3 x 10^9 vp | Forced Vital Capacity (FVC) | Post TB Treatment | 3 participants |
| AERAS-402 3 x 10^10 vp | Forced Vital Capacity (FVC) | Post TB Treatment | 4 participants |
| AERAS-402 3 x 10^10 vp | Forced Vital Capacity (FVC) | On TB Treatment | 1 participants |
Primary
Number of Participants With Solicited and Unsolicited AEs
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.
Time frame: 182 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Solicited and Unsolicited AEs | 11 participants |
| AERAS-402 3 x 10^8 vp | Number of Participants With Solicited and Unsolicited AEs | 10 participants |
| AERAS-402 3 x 10^9 vp | Number of Participants With Solicited and Unsolicited AEs | 20 participants |
| AERAS-402 3 x 10^10 vp | Number of Participants With Solicited and Unsolicited AEs | 30 participants |
Secondary
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the on TB Treatment Stratum
Assessment 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.
Time frame: 42 days post dose
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| AERAS-402 3 x 10^8 vp | 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 | 0.025 percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 |
| AERAS-402 3 x 10^8 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 |
| AERAS-402 3 x 10^8 vp | 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 |
| AERAS-402 3 x 10^8 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 |
| AERAS-402 3 x 10^8 vp | 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 | 0.056 percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 | 0.053 percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 |
| AERAS-402 3 x 10^9 vp | 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 | 0.057 percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 |
| AERAS-402 3 x 10^9 vp | 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 | 0.052 percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 | 0.063 percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 |
| AERAS-402 3 x 10^10 vp | 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 | 0.043 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 | 0.025 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 | 0.072 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 | 0.061 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 |
| AERAS-402 3 x 10^10 vp | 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 |
| AERAS-402 3 x 10^10 vp | 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 | 0.489 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 | 0.082 percentage of T Cell response |
Secondary
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the Post TB Treatment Stratum
Assessment 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.
Time frame: 42 days post dose
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| AERAS-402 3 x 10^8 vp | 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 |
| AERAS-402 3 x 10^8 vp | 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 | 0.038 percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 | 0.056 percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 |
| AERAS-402 3 x 10^8 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 |
| AERAS-402 3 x 10^8 vp | 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 |
| AERAS-402 3 x 10^8 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 | 0.040 percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 |
| AERAS-402 3 x 10^9 vp | 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 | 0.089 percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 |
| AERAS-402 3 x 10^9 vp | 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 | 0.076 percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 | 0.089 percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 |
| AERAS-402 3 x 10^10 vp | 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 |
| AERAS-402 3 x 10^10 vp | 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 | 0.091 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 | 0.057 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 |
| AERAS-402 3 x 10^10 vp | 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 |
| AERAS-402 3 x 10^10 vp | 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 |
| AERAS-402 3 x 10^10 vp | 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 | 0.547 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 | 0.105 percentage of T Cell response |
Secondary
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the on TB Treatment Stratum
Assessment 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.
Time frame: 42 days post dose
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| AERAS-402 3 x 10^8 vp | 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 |
| AERAS-402 3 x 10^8 vp | 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 | 0.089 percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 | 0.068 percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 |
| AERAS-402 3 x 10^8 vp | 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 |
| AERAS-402 3 x 10^8 vp | 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 | 0.085 percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 |
| AERAS-402 3 x 10^9 vp | 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 |
| AERAS-402 3 x 10^9 vp | 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 | 0.301 percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 |
| AERAS-402 3 x 10^9 vp | 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 | 0.310 percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 |
| AERAS-402 3 x 10^9 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 | 0.076 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 |
| AERAS-402 3 x 10^10 vp | 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 |
| AERAS-402 3 x 10^10 vp | 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 | 0.079 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 | 0.223 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 |
| AERAS-402 3 x 10^10 vp | 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 | 0.125 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 | 0.169 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 | 0.571 percentage of T Cell response |
Secondary
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the Post TB Treatment Stratum
Assessment 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.
Time frame: 42 days post dose
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| AERAS-402 3 x 10^8 vp | 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 |
| AERAS-402 3 x 10^8 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 |
| AERAS-402 3 x 10^8 vp | 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 | 0.584 percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 | 0.439 percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^8 vp | 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 |
| AERAS-402 3 x 10^8 vp | 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 |
| AERAS-402 3 x 10^9 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 | 0.206 percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 |
| AERAS-402 3 x 10^9 vp | 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 |
| AERAS-402 3 x 10^9 vp | 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 |
| AERAS-402 3 x 10^9 vp | 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 |
| AERAS-402 3 x 10^9 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 | NA percentage of T Cell response |
| AERAS-402 3 x 10^9 vp | 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 | 0.083 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 | 0.104 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 |
| AERAS-402 3 x 10^10 vp | 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 | 0.169 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 |
| AERAS-402 3 x 10^10 vp | 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 | 0.673 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 |
| AERAS-402 3 x 10^10 vp | 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 |
| AERAS-402 3 x 10^10 vp | 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 | 0.054 percentage of T Cell response |
| AERAS-402 3 x 10^10 vp | 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 | 0.400 percentage of T Cell response |