Tuberculosis
Conditions
Keywords
Tuberculosis, Vaccine, Immunogenicity, Prevention of Tuberculosis
Brief summary
AERAS-402 will be given to infants of at least 16 weeks of age who have already been vaccinated with BCG to determine if AERAS-402 will increase protection of infants to tuberculosis.
Detailed description
The only currently available tuberculosis vaccine, bacillus Calmette-Guérin (BCG), is estimated to reduce the risk of tuberculosis (TB) in children by up to 70-80%, but protection is incomplete. Efforts to increase TB protection in children include new vaccines for primary immunizations as well as combinations of vaccines given as primary and boosting vaccinations. AERAS 402 is a live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens (Ag85A, Ag85B and TB10.4). It presents Mtb antigens in the setting of a new, live, replication-deficient adenovirus vaccine that may increase T cell-mediated immunity and thus protection from tuberculosis. AERAS-402 appears safe and immunogenic in adults. Since BCG-vaccinated infants are the population for which AERAS-402 might be indicated, AERAS-402 will be administered to infants of at least 16 weeks of age who have already been vaccinated with BCG. This is the first Phase II study of AERAS-402 in infants.
Interventions
BIOLOGICALAERAS-402 1.5 x 10^10 vp
BIOLOGICALAERAS-402 3.0 x 10^10 vp
BIOLOGICALAERAS-402 1.0 x 10^11 vp
BIOLOGICALPlacebo
Sponsors
European and Developing Countries Clinical Trials Partnership (EDCTP)
Aeras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
112 Days to 182 Days
Healthy volunteers
Yes
Inclusion criteria
1. Parent/legal guardian has completed the written informed consent process 2. Is age greater than or equal to 112 days (16 weeks) and less than or equal 182 days (26 weeks) on Study Day 0 3. Has general good health, confirmed by medical history and physical examination 4. Is up to date on all Expanded Program of Immunization (EPI) immunizations for his/her age with a minimum of 14 days between the last EPI vaccination and administration of study vaccine on Study Day 0 5. Has ability to complete follow-up period of 728 days as required by the protocol 6. Parent/legal guardian is able and willing to stay in contact with the study site for the duration of the study and to provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study 7. Has completed simultaneous enrollment in Aeras Vaccine Development Registry protocol 8. Had BCG vaccination ≥ 3 months prior to randomization documented by medical card
Exclusion criteria
1. Acute illness, evidence of any significant active infection or temperature \>=37.5°C on the day of randomization 2. Used immunosuppressive medication within 45 days before entry into the study (inhaled and topical corticosteroids are permitted) 3. Received immunoglobulin or blood products within 45 days before entry into the study 4. Ever received any investigational drug therapy or investigational vaccine 5. History or laboratory evidence of individual immunodeficiency virus (HIV-1) infection 6. History of allergic disease or reactions to any component of the study vaccine 7. Previous medical history that may compromise the safety of the participant in the study 8. Evidence of a new acute illness that may compromise the safety of the participant in the study 9. Inability to discontinue daily medications during the study 10. History or evidence of any systemic disease on physical examination or any acute or chronic illness that may interfere with the evaluation of the safety or immunogenicity of the vaccine, e.g., including masses between the leg and abdomen (e.g., inguinal hernia or lymphadenopathy) 11. History or evidence of active tuberculosis 12. A positive QuantiFERON®-TB Gold In-Tube test 13. A household contact with active TB disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Collected Per Subject | Up to 24 months post vaccination | Adverse Events (AEs) are recorded for 28 days post vaccination Serious Adverse Events (SAEs) are recorded for the entire study period to assess the safety profile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | 28 days post last vaccination | To evaluate the immunogenicity of AERAS-402 compared to controls, flow cytometric ICS of CD4 and CD8 T cells producing any of three cytokines (IFN-γ, TNF-α, and/or IL-2) alone or in combination after stimulation with a peptide pool of mycobacterial peptides. Dimethylsulfoxide (DMSO) subtracted responses are presented. |
| Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay | 28 days post last vaccination | To evaluate the immunogenicity of AERAS-402 compared to controls. ELISpot assay of specific T cell responses after stimulation with a peptide pool of mycobacterial peptides. Values presented have been corrected for background readings. |
| Antigen-specific Antibody Response - Mean Optical Density (Mean OD) | 28 day post last vaccination | To evaluate the immunogenicity of AERAS-402 compared to controls by ELISA Assay for Antigen-specific Antibody Response. Median responses of individual Mean OD (absorbance at 450nm) by study group is presented. Higher OD values suggests the presence of antibody to each of the Mtb antigens (Ag85A, Ag85B and TB10.4). |
| Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination | up to 24 months post vaccination | To evaluate the proportion of on-study QuantiFERON conversions from negative to positive in infants that received AERAS-402 compared to controls. A QFT value of on \>= 0.35IU/mL was considered positive for this study. |
Countries
Kenya, Mozambique, South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dose Finding - Group 1 Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.
Placebo: Sterile buffer | 52 |
| Dose Finding - Group 2 Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10\^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.5 x 10\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens. | 51 |
| Dose Finding - Group 3 Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10\^10 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 3.0 x 10\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens. | 51 |
| Dose Finding - Group 4 Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10\^11 vp) once on Study Day 0 and again on Study Day 28.
AERAS-402 1.0 x 10\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens. | 52 |
| Expanded Safety Phase - Group 5 Subjects received 3 doses of AERAS-402 (1 X 10\^11 vp) on days 0, 28 and 280.
AERAS-402 1.0 x 10\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens. | 140 |
| Expanded Safety Phase - Group 5 Placebo Subjects received 3 doses of placebo on days 0, 28 and 280.
Placebo: Sterile buffer | 141 |
| Total | 487 |
Baseline characteristics
| Characteristic | Expanded Safety Phase - Group 5 Placebo | Total | Dose Finding - Group 1 | Dose Finding - Group 2 | Dose Finding - Group 3 | Dose Finding - Group 4 | Expanded Safety Phase - Group 5 |
|---|---|---|---|---|---|---|---|
| Age, Customized Age at Study Day 0 in Days | 150.2 Days STANDARD_DEVIATION 20.22 | 146.3 Days STANDARD_DEVIATION 19.97 | 145.3 Days STANDARD_DEVIATION 18.15 | 144.5 Days STANDARD_DEVIATION 17.83 | 138.6 Days STANDARD_DEVIATION 19.45 | 149.1 Days STANDARD_DEVIATION 21.44 | 145.2 Days STANDARD_DEVIATION 19.98 |
| Race/Ethnicity, Customized Asian | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black | 98 participants | 370 participants | 42 participants | 44 participants | 41 participants | 43 participants | 102 participants |
| Race/Ethnicity, Customized Coloured | 43 participants | 117 participants | 10 participants | 7 participants | 10 participants | 9 participants | 38 participants |
| Race/Ethnicity, Customized Other | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Region of Enrollment Kenya | 71 participants | 285 participants | 36 participants | 36 participants | 36 participants | 36 participants | 70 participants |
| Region of Enrollment Mozambique | 0 participants | 14 participants | 4 participants | 3 participants | 3 participants | 4 participants | 0 participants |
| Region of Enrollment South Africa | 70 participants | 188 participants | 12 participants | 12 participants | 12 participants | 12 participants | 70 participants |
| Sex: Female, Male Female | 57 Participants | 217 Participants | 22 Participants | 20 Participants | 30 Participants | 20 Participants | 68 Participants |
| Sex: Female, Male Male | 84 Participants | 270 Participants | 30 Participants | 31 Participants | 21 Participants | 32 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 48 / 52 | 47 / 51 | 49 / 51 | 52 / 52 | 136 / 140 | 139 / 141 |
| serious Total, serious adverse events | 20 / 52 | 25 / 51 | 23 / 51 | 18 / 52 | 40 / 140 | 38 / 141 |
Outcome results
Primary
Adverse Events Collected Per Subject
Adverse Events (AEs) are recorded for 28 days post vaccination Serious Adverse Events (SAEs) are recorded for the entire study period to assess the safety profile
Time frame: Up to 24 months post vaccination
Population: Subjects who received at least one vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dose Finding - Group 1 | Adverse Events Collected Per Subject | 94.2 percentage of subjects with an AE |
| Dose Finding - Group 2 | Adverse Events Collected Per Subject | 96.1 percentage of subjects with an AE |
| Dose Finding - Group 3 | Adverse Events Collected Per Subject | 100.0 percentage of subjects with an AE |
| Dose Finding - Group 4 | Adverse Events Collected Per Subject | 100.0 percentage of subjects with an AE |
| Expanded Safety Phase - Group 5 | Adverse Events Collected Per Subject | 100.0 percentage of subjects with an AE |
| Expanded Safety Phase - Group 5 Placebo | Adverse Events Collected Per Subject | 98.6 percentage of subjects with an AE |
Secondary
Antigen-specific Antibody Response - Mean Optical Density (Mean OD)
To evaluate the immunogenicity of AERAS-402 compared to controls by ELISA Assay for Antigen-specific Antibody Response. Median responses of individual Mean OD (absorbance at 450nm) by study group is presented. Higher OD values suggests the presence of antibody to each of the Mtb antigens (Ag85A, Ag85B and TB10.4).
Time frame: 28 day post last vaccination
Population: Groups 1 and 4: Subjects who received both vaccinations as randomized (assays were not done for Ag85A and TB10.4).~Assays were not done for groups 2 and 3 for any antigen. Group 5: Subjects who received all three study vaccinations as randomized.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dose Finding - Group 1 | Antigen-specific Antibody Response - Mean Optical Density (Mean OD) | Ag85A | NA Optical Density |
| Dose Finding - Group 1 | Antigen-specific Antibody Response - Mean Optical Density (Mean OD) | TB10.4 | NA Optical Density |
| Dose Finding - Group 1 | Antigen-specific Antibody Response - Mean Optical Density (Mean OD) | Ag85B | 0.26 Optical Density |
| Dose Finding - Group 4 | Antigen-specific Antibody Response - Mean Optical Density (Mean OD) | Ag85A | NA Optical Density |
| Dose Finding - Group 4 | Antigen-specific Antibody Response - Mean Optical Density (Mean OD) | TB10.4 | NA Optical Density |
| Dose Finding - Group 4 | Antigen-specific Antibody Response - Mean Optical Density (Mean OD) | Ag85B | 2.15 Optical Density |
| Expanded Safety Phase - Group 5 | Antigen-specific Antibody Response - Mean Optical Density (Mean OD) | Ag85B | 2.17 Optical Density |
| Expanded Safety Phase - Group 5 | Antigen-specific Antibody Response - Mean Optical Density (Mean OD) | Ag85A | 1.34 Optical Density |
| Expanded Safety Phase - Group 5 | Antigen-specific Antibody Response - Mean Optical Density (Mean OD) | TB10.4 | 0.94 Optical Density |
| Expanded Safety Phase - Group 5 Placebo | Antigen-specific Antibody Response - Mean Optical Density (Mean OD) | Ag85A | 0.20 Optical Density |
| Expanded Safety Phase - Group 5 Placebo | Antigen-specific Antibody Response - Mean Optical Density (Mean OD) | TB10.4 | 0.34 Optical Density |
| Expanded Safety Phase - Group 5 Placebo | Antigen-specific Antibody Response - Mean Optical Density (Mean OD) | Ag85B | 0.37 Optical Density |
Secondary
Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay
To evaluate the immunogenicity of AERAS-402 compared to controls. ELISpot assay of specific T cell responses after stimulation with a peptide pool of mycobacterial peptides. Values presented have been corrected for background readings.
Time frame: 28 days post last vaccination
Population: Groups 1 and 4: Subjects who received both vaccinations as randomized (assays were not done for Groups 2 and 3).~Group 5: Subjects who received all three study vaccinations as randomized.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dose Finding - Group 1 | Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay | Ag85A | 5.00 SFU/10^6 PBMC |
| Dose Finding - Group 1 | Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay | TB10.4 | 5.42 SFU/10^6 PBMC |
| Dose Finding - Group 1 | Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay | Ag85B | 0.42 SFU/10^6 PBMC |
| Dose Finding - Group 4 | Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay | Ag85A | 87.92 SFU/10^6 PBMC |
| Dose Finding - Group 4 | Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay | TB10.4 | 26.67 SFU/10^6 PBMC |
| Dose Finding - Group 4 | Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay | Ag85B | 127.08 SFU/10^6 PBMC |
| Expanded Safety Phase - Group 5 | Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay | Ag85B | 65.00 SFU/10^6 PBMC |
| Expanded Safety Phase - Group 5 | Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay | Ag85A | 98.33 SFU/10^6 PBMC |
| Expanded Safety Phase - Group 5 | Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay | TB10.4 | 17.50 SFU/10^6 PBMC |
| Expanded Safety Phase - Group 5 Placebo | Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay | Ag85A | 0.00 SFU/10^6 PBMC |
| Expanded Safety Phase - Group 5 Placebo | Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay | TB10.4 | 3.33 SFU/10^6 PBMC |
| Expanded Safety Phase - Group 5 Placebo | Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay | Ag85B | 0.83 SFU/10^6 PBMC |
Secondary
Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects
To evaluate the immunogenicity of AERAS-402 compared to controls, flow cytometric ICS of CD4 and CD8 T cells producing any of three cytokines (IFN-γ, TNF-α, and/or IL-2) alone or in combination after stimulation with a peptide pool of mycobacterial peptides. Dimethylsulfoxide (DMSO) subtracted responses are presented.
Time frame: 28 days post last vaccination
Population: Groups 1-4: Subjects who received both vaccinations as randomized. Group 5: Subjects who received all three study vaccinations as randomized.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dose Finding - Group 1 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | TB10.4 CD4 | 0.01 percentage of Tcell response |
| Dose Finding - Group 1 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | TB10.4 CD8 | 0.00 percentage of Tcell response |
| Dose Finding - Group 1 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85A CD4 | 0.00 percentage of Tcell response |
| Dose Finding - Group 1 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85A CD8 | 0.00 percentage of Tcell response |
| Dose Finding - Group 1 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85B CD4 | 0.00 percentage of Tcell response |
| Dose Finding - Group 1 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85B CD8 | 0.00 percentage of Tcell response |
| Dose Finding - Group 2 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85B CD8 | 0.04 percentage of Tcell response |
| Dose Finding - Group 2 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85A CD4 | 0.01 percentage of Tcell response |
| Dose Finding - Group 2 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | TB10.4 CD8 | 0.01 percentage of Tcell response |
| Dose Finding - Group 2 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85A CD8 | 0.01 percentage of Tcell response |
| Dose Finding - Group 2 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85B CD4 | 0.02 percentage of Tcell response |
| Dose Finding - Group 2 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | TB10.4 CD4 | 0.01 percentage of Tcell response |
| Dose Finding - Group 3 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85B CD8 | 0.03 percentage of Tcell response |
| Dose Finding - Group 3 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85A CD8 | 0.01 percentage of Tcell response |
| Dose Finding - Group 3 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | TB10.4 CD8 | 0.00 percentage of Tcell response |
| Dose Finding - Group 3 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85A CD4 | 0.02 percentage of Tcell response |
| Dose Finding - Group 3 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85B CD4 | 0.02 percentage of Tcell response |
| Dose Finding - Group 3 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | TB10.4 CD4 | 0.01 percentage of Tcell response |
| Dose Finding - Group 4 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85B CD8 | 0.04 percentage of Tcell response |
| Dose Finding - Group 4 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85B CD4 | 0.03 percentage of Tcell response |
| Dose Finding - Group 4 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | TB10.4 CD8 | 0.01 percentage of Tcell response |
| Dose Finding - Group 4 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85A CD4 | 0.02 percentage of Tcell response |
| Dose Finding - Group 4 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85A CD8 | 0.02 percentage of Tcell response |
| Dose Finding - Group 4 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | TB10.4 CD4 | 0.01 percentage of Tcell response |
| Expanded Safety Phase - Group 5 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85B CD4 | 0.01 percentage of Tcell response |
| Expanded Safety Phase - Group 5 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85B CD8 | 0.05 percentage of Tcell response |
| Expanded Safety Phase - Group 5 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | TB10.4 CD8 | 0.01 percentage of Tcell response |
| Expanded Safety Phase - Group 5 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85A CD4 | 0.02 percentage of Tcell response |
| Expanded Safety Phase - Group 5 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85A CD8 | 0.04 percentage of Tcell response |
| Expanded Safety Phase - Group 5 | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | TB10.4 CD4 | 0.01 percentage of Tcell response |
| Expanded Safety Phase - Group 5 Placebo | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85A CD4 | 0.00 percentage of Tcell response |
| Expanded Safety Phase - Group 5 Placebo | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | TB10.4 CD4 | 0.00 percentage of Tcell response |
| Expanded Safety Phase - Group 5 Placebo | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | TB10.4 CD8 | 0.00 percentage of Tcell response |
| Expanded Safety Phase - Group 5 Placebo | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85B CD8 | 0.00 percentage of Tcell response |
| Expanded Safety Phase - Group 5 Placebo | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85A CD8 | 0.00 percentage of Tcell response |
| Expanded Safety Phase - Group 5 Placebo | Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects | Ag85B CD4 | 0.00 percentage of Tcell response |
Secondary
Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination
To evaluate the proportion of on-study QuantiFERON conversions from negative to positive in infants that received AERAS-402 compared to controls. A QFT value of on \>= 0.35IU/mL was considered positive for this study.
Time frame: up to 24 months post vaccination
Population: Subjects who received at least one vaccination and had results at baseline and end of study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dose Finding - Group 1 | Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination | 0 % converting from QFT neg to pos |
| Dose Finding - Group 2 | Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination | 13.6 % converting from QFT neg to pos |
| Dose Finding - Group 3 | Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination | 0 % converting from QFT neg to pos |
| Dose Finding - Group 4 | Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination | 4.3 % converting from QFT neg to pos |
| Expanded Safety Phase - Group 5 | Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination | 2.4 % converting from QFT neg to pos |
| Expanded Safety Phase - Group 5 Placebo | Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination | 4.7 % converting from QFT neg to pos |