Healthy
Conditions
Brief summary
The primary purpose of this study is to assess safety/tolerability of the different vaccine regimens and of a late boost vaccination; and to assess envelope (Env)-binding antibody (Ab) responses of the 2 different vaccine regimens.
Detailed description
This is a randomized (study medication assigned by chance), double-blind (neither physician nor participant knows the treatment received), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (each treatment group will be treated at the same time), multicenter (more than one clinical site) study in healthy human immunodeficiency virus (HIV)-uninfected adults. The main study will be conducted in 3 phases: a 6-week screening period; a 48-week vaccination period; and a follow-up period to the final main study visit at Week 72. A Long-term Extension (LTE) phase (approximately 3 years after Week 72) will be performed for participants randomized to Group 1 or Group 2, who receive all 4 vaccinations and are negative for HIV infection at Week 72. The approximate duration of the study will be approximately 78 weeks for participants not participating in the LTE phase and approximately 222 weeks for participants participating in the LTE phase but not receiving a late boost vaccination and approximately 246 (12-month follow-up) or 294 (24-month follow-up) weeks for participants receiving a late boost vaccination. Participants safety will be monitored throughout the study.
Interventions
BIOLOGICALAd26.Mos4.HIV
Ad26.Mos4.HIV at a dose of 5\*10\^10 viral particles (vp), administered intramuscularly.
BIOLOGICALClade C gp140 plus adjuvant
Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 milliliter (mL) injection administered intramuscularly.
BIOLOGICALClade C gp140/Mosaic gp140 plus adjuvant
Clade C gp140 and Mosaic gp140 (each 125 mcg of total protein) mixed with aluminum phosphate adjuvant, per 0.5 milliliter (mL) injection, administered intramuscularly.
OTHERPlacebo
Placebo Containing 0.9 percent normal saline, administered intramuscularly.
BIOLOGICALgp140 HIV Bivalent Vaccine
gp140 HIV Bivalent Vaccine is adjuvanted protein co-formulation with a dosage strength of 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant).
Sponsors
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participant must be healthy on the basis of medical history, physical examination, and vital signs measurement performed at screening * Participants are negative for human immunodeficiency virus (HIV) infection at screening * Participants are amenable to HIV-risk reduction counseling and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit * All female participants of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[beta-hCG\]) at the screening visit, and a negative urine pregnancy test pre-dose on Day 1 * Participants are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures * Participant must be enrolled in the LTE phase to receive the late boost vaccination
Exclusion criteria
* Has chronic hepatitis B (measured by hepatitis B surface antigen test) or active hepatitis C (measured by hepatitis C virus \[HCV\] Ab test; if positive, HCV ribonucleic acid \[RNA\] polymerase chain reaction (PCR) test will be used to confirm active versus past HCV infection), active syphilis infection, chlamydia, gonorrhea, or trichomonas * In the 12 months prior to randomization, participant has a history of newly acquired herpes simplex virus type 2 (HSV-2), syphilis, gonorrhea, non-gonococcal urethritis, chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B * Participant has had major surgery (eg, requiring general anesthesia) within the 4 weeks before screening, or will not have fully recovered from surgery, or has surgery planned through the course of the study * Participant has had a thyroidectomy or active thyroid disease requiring medication during the last 12 months (not excluded: a stable thyroid supplementation) * Current or past drug/alcohol use that investigator assesses poses any more than a remotely increased risk of the ability of the participant to comply with the protocol requirements * Has been in receipt of any licensed vaccine within 14 days prior to the first dose of study vaccine or placebo, plans to receive within 14 days after the first study vaccination, or plans to receive within 14 days before or after the second, third or fourth vaccination * Is a recipient of a prophylactic or therapeutic HIV vaccine candidate at any time, or a recipient of other experimental vaccine(s) within the last 12 months prior to the Day 1 visit (Vaccination 1). For participants who received an experimental vaccine (except HIV vaccine) more than 12 months prior to the Day 1 visit (Vaccination 1), documentation of the identity of the experimental vaccine must be provided to the sponsor, who will determine eligibility on a case-by-case basis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 288 | Week 288 | Geometric mean of Env Mos 1 specific binding Abs response at Week 288 were assessed using ELISA. |
| Late-boost (LB) Vaccination Phase: Number of Participants Who Discontinued Study Due to AEs | From Week 188 up to end of study (Week 288) | Number of participants who discontinued study due to AEs were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. |
| Late-boost (LB) Vaccination Phase: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post Late Boost Vaccination | Up to 7 days post late boost vaccination (up to any day from Day 1317 to Day 1464) (late boost vaccination ranged from Day 1317 to 1457) | Number of participants with solicited local and systemic AEs for 7 days post late boost vaccination were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Solicited AEs were precisely local and systemic events for which the participant is specifically questioned and symptoms of which were noted by participant in their diary. Solicited local AEs included injection site pain/tenderness, erythema, and swelling/induration at the study vaccine injection site. Solicited systemic AEs included fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills. |
| Late-boost (LB) Vaccination Phase: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post Late Boost Vaccination | Up to 28 days post late boost vaccination (up to any day from Day 1317 to Day 1485) (late boost vaccination ranged from Day 1317 to 1457) | Number of participants with unsolicited AEs for 28 post late boost vaccination were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Late-boost (LB) Vaccination Phase: Number of Participants With Serious Adverse Events (SAEs) | From Week 188 up to end of study (Week 288) | Number of participants with SAEs were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. |
| Late-boost (LB) Vaccination Phase: Number of Participants With AESIs of HIV Infection Up to End of Study | From Week 188 up to end of study (Week 288) | Number of participants with AESIs up to the end of the study were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. AESIs (including potential AESIs) are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. AESIs (including potential AESIs) must be reported to the sponsor within 24 hours of awareness irrespective of seriousness (i.e, serious and nonserious AEs) or causality. Confirmed HIV infection was considered an AESI. |
| Late-boost (LB) Vaccination Phase: Number of Participants With AESIs of Thrombosis With Thrombocytopenia Syndrome (TTS) | Up to 6 months post late boost vaccination (up to any day from Day 1317 to Day 1639) (late boost vaccination ranged from Day 1317 to 1457) | Number of participants with AESIs of TTS were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. AESIs must be reported to the sponsor within 24 hours of awareness irrespective of seriousness (i.e, serious and nonserious AEs) or causality. Thrombotic events and/or thrombocytopenia were considered as AESIs. |
| Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28 | Week 28 | Geometric mean of Env Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 specific binding Abs responses were assessed using ELISA. |
| Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52 | Week 52 | Geometric mean of Env Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 specific binding Abs responses were assessed using ELISA. |
| Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72 | Week 72 | Geometric mean of Env Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 specific binding Abs responses were assessed using ELISA. |
| Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Week 28 | Percentage of responders for envelop (Env) Clade B (SC42261), Clade C (CH505TF), Clade A (9004S), Clade B (RHPA), Clade B (WITO), Clade C (1086C), Clade C (BF1266), CladeAE (conAE), Clade M(Con S)-specific binding antibody titers assessed using enzyme-linked immunosorbent assay (ELISA) were reported. The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline value less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value greater than or equal to (\>=) LLOQ. |
| Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Week 52 | Percentage of responders for envelop (Env) Clade B (SC42261), Clade C (CH505TF), Clade A (9004S), Clade B (RHPA), Clade B (WITO), Clade C (1086C), Clade C (BF1266), CladeAE (conAE), Clade M(Con S)-specific binding antibody titers assessed using enzyme-linked immunosorbent assay (ELISA) were reported. The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline value less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value greater than or equal to (\>=) LLOQ. |
| Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Week 72 | Percentage of responders for envelop (Env) Clade B (SC42261), Clade C (CH505TF), Clade A (9004S), Clade B (RHPA), Clade B (WITO), Clade C (1086C), Clade C (BF1266), CladeAE (conAE), Clade M(Con S)-specific binding antibody titers assessed using enzyme-linked immunosorbent assay (ELISA) were reported. The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline value less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value greater than or equal to (\>=) LLOQ. |
| Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 192 | Week 192 | Geometric mean of Env Mos 1 specific binding Abs response at Week 192 were assessed using ELISA. |
| Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 193 | Week 193 | Geometric Mean of Env Mos 1 specific binding Abs response at Week 193 were assessed using ELISA. |
| Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 196 | Week 196 | Geometric mean of Env Mos 1 specific binding Abs response at Week 196 were assessed using ELISA. |
| Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 204 | Week 204 | Geometric mean of Env Mos 1 specific binding Abs response at Week 204 were assessed using ELISA. |
| Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 216 | Week 216 | Geometric mean of Env Mos 1 specific binding Abs response at Week 216 were assessed using ELISA. |
| Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 240 | Week 240 | Geometric mean of Env Mos 1 specific binding Abs response at Week 240 were assessed using ELISA. |
| Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 1 | Up to 7 days post-vaccination 1 on Day 1 (up to Day 8) | Number of participants with solicited local and systemic AEs for 7 days post-vaccination 1 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Solicited AEs were precisely local and systemic events for which the participant is specifically questioned and symptoms of which were noted by participant in their diary. Solicited local AEs included injection site pain/tenderness, erythema, and swelling/induration at the study vaccine injection site. Solicited systemic AEs included fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills. |
| Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 2 | Up to 7 days post vaccination 2 (up to any day from Day 78 to Day 113) (vaccination 2 ranged from Day 78 to 106) | Number of participants with solicited local and systemic AEs for 7 days post-vaccination 2 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Solicited AEs were precisely local and systemic events for which the participant is specifically questioned and symptoms of which were noted by participant in their diary. Solicited local AEs included injection site pain/tenderness, erythema, and swelling/induration at the study vaccine injection site. Solicited systemic AEs included fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills. |
| Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 3 | Up to 7 days post vaccination 3 (up to any day from Day 162 to Day 197) (vaccination 3 ranged from Day 162 to 190) | Number of participants with solicited local and systemic AEs for 7 days post-vaccination 3 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Solicited AEs were precisely local and systemic events for which the participant is specifically questioned and symptoms of which were noted by participant in their diary. Solicited local AEs included injection site pain/tenderness, erythema, and swelling/induration at the study vaccine injection site. Solicited systemic AEs included fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills. |
| Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 4 | Up to 7 days post vaccination 4 (up to any day from Day 330 to Day 365) (vaccination 4 ranged from Day 330 to 358) | Number of participants with solicited local and systemic AEs for 7 days post-vaccination 4 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Solicited AEs were precisely local and systemic events for which the participant is specifically questioned and symptoms of which were noted by participant in their diary. Solicited local AEs included injection site pain/tenderness, erythema, and swelling/induration at the study vaccine injection site. Solicited systemic AEs included fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills. |
| Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 1 | Up to 28 days post-vaccination 1 on Day 1 (Up to Day 29) | Number of participants with unsolicited AEs for 28 days post-vaccination 1 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 2 | Up to 28 days post vaccination 2 (up to any day from Day 78 to Day 134) (vaccination 2 ranged from Day 78 to 106) | Number of participants with unsolicited AEs for 28 days post-vaccination 2 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 3 | Up to 28 days post vaccination 3 (up to any day from Day 162 to Day 218) (vaccination 3 ranged from Day 162 to 190) | Number of participants with unsolicited AEs for 28 days post-vaccination 3 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 4 | Up to 28 days post vaccination 4 (up to any day from Day 330 to Day 358) (vaccination 4 ranged from Day 330 to 358) | Number of participants with unsolicited AEs for 28 days post-vaccination 4 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Main Study: Number of Participants Who Discontinued Study Vaccination Due to AEs | From Baseline (Day 1) up to Week 72 | Number of participants who discontinued study vaccination due to AEs were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. |
| Main Study: Number of Participants With Serious Adverse Events (SAEs) | From Baseline (Day 1) up to Week 72 | Number of participants with SAEs were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. |
| Main Study and LTE Study: Number of Participants With Adverse Events of Special Interest (AESIs) | From Baseline (Day 1) up to Week 216 | Number of participants with adverse events of special interest (AESIs) were reported. As planned, confirmed HIV infection was the only event assessed as an AESI. AESIs (including potential AESIs) are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. AESIs (including potential AESIs) must be reported to the sponsor within 24 hours of awareness irrespective of seriousness (that is, serious and nonserious AEs) or causality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term Extension (LTE) Phase: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | From Week 72 to Week 216 | Percentage of responders of Env-specific nAbs for tier 1 viruses were planned to be reported. |
| Late-boost (LB) Vaccination Phase: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | From Week 188 up to end of study (Week 288) | Percentage of responders of Env-specific nAbs for tier 1 viruses were planned to be reported. |
| Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | Weeks 28, 52, and 72 (Weeks 52 and 72 are only for HIV ENV [gp140 T sortA] C [ZA] F Ab) | Percentage of responders for Env-specific functional antibody response (Env ADCP gp140) were reported. The response was defined as post-baseline value \> limit of detection (LOD) if baseline value \<LOD or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value \>=LOD. The lower limits of detection (LODs) for this assay were 5.16, 6.43, 6.49, 4.32 and 4.28 (phagocytic score) for Clade A (92UG037.1), Clade B (1990a), Clade C (Con C), Clade C (ZA), and Mos1, respectively. |
| Long-term Extension (LTE) Phase: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | From Week 72 up to Week 216 | Percentage of responders for Env-specific functional antibody response (Env ADCP gp140) were planned to be reported. |
| Late-boost (LB) Vaccination Phase: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | From Week 188 up to end of study (Week 288) | Percentage of responders for Env-specific functional antibody response (Env ADCP gp140) were planned to be reported. |
| Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | Weeks 28, 52, and 72 | Percentage of responders for Env-specific binding Ab isotypes (IgG1 and IgG3) for Clade C (ZA) as assessed using ELISA were reported. The response was defined as post-baseline value \>LLOQ if baseline \<LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=LLOQ. The LLOQs for this assay were 12.3 and 12.4 EC50 for IgG1 and IgG3, respectively. EC50= 50% effective concentration. |
| Long-term Extension (LTE) Phase: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | From Week 72 up to Week 216 | Percentage of responders for Env-specific binding Ab isotypes IgG1 and IgG3) were planned to be reported. |
| Late-boost (LB) Vaccination Phase: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | From Week 188 up to end of study (Week 288) | Percentage of responders for Env-specific binding Ab isotypes IgG1 and IgG3) were planned to be reported. |
| Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | Weeks 28, 52, and 72 | Percentage of IFN-gamma PBMC responders to mosaic and PTE peptide pools of Env/Gag/Pol as assessed by ELISpot was reported. The response was defined as post-baseline value \>P95 if baseline \<P95 or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=P95. |
| Long-term Extension (LTE) Phase: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | From Week 72 up to Week 216 | Percentage of Interferon (IFN)-Gamma PBMC responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) was planned to be reported. |
| Late-boost (LB) Vaccination Phase: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | From Week 188 up to end of study (Week 288) | Percentage of Interferon (IFN)-Gamma PBMC responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) were planned to be reported. |
| Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | Weeks 28, 52, and 72 | Percentage of responders with CD4+ and CD8+ T-cell functionality (cells producing IFN-gamma and /or IL-2) were reported. Intracellular cytokine staining (ICS) was performed to examine the type of T-cell responding to vaccination. Responder definition was based on the Fisher's exact text between cytokine producing cells and non-producing cells in stimulated versus non-stimulated conditions. |
| Long-term Extension (LTE) Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | From Week 72 up to Week 216 | Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality (cells Producing IFN-Gamma and/or Interleukin \[IL-2\]) were planned to be reported. Intracellular cytokine staining (ICS) was performed to examine the type of T-cell responding to vaccination. Responder definition was based on the Fisher's exact text between cytokine producing cells and non-producing cells in stimulated versus non-stimulated conditions. |
| Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | Weeks 192 and 196 | Percentage of responders with CD4+ and CD8+ T-cell functionality (cells producing IFN-gamma and /or IL-2) were reported. Intracellular cytokine staining (ICS) was performed to examine the type of T-cell responding to vaccination. Responder definition was based on the Fisher's exact text between cytokine producing cells and non-producing cells in stimulated versus non-stimulated conditions. |
| Main Study: Percentage of Participants With T-Cell Development | From Baseline (Day 1) up to Week 72 | Percentage of participants with T-Cell development were planned to be reported. |
| Long-term Extension (LTE) Phase: Percentage of Participants With T-Cell Development | From Week 72 up to Week 216 | Percentage of participants with T-Cell development were planned to be reported. |
| Late-boost (LB) Vaccination Phase: Percentage of Participants With T-Cell Development | From Week 188 up to end of study (Week 288) | Percentage of participants with T-Cell Development were planned to be reported. |
| Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Weeks 28, 52, and 72 (only for Clade C [MW965]) | Percentage of responders of Env-specific nAbs for tier 1 viruses were reported. Viruses with a Tier 1 neutralization phenotype: Clade C: MW965 and 97ZA012, ZM233M, CE703010010, 2759058, ZM215F, SO431, CE704810053 were used. The response was defined as post-baseline value \>LLOQ. |
Countries
Kenya, Rwanda, United States
Participant flow
Pre-assignment details
From Week 192 (-4 weeks/+ 4 months), eligible and consenting participants in long-term extension (LTE) phase received late boost vaccination and continued in late boost vaccination phase. Hence, there is an overlap in the duration of LTE and late boost vaccination phase.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 Participants in the main study received single intramuscular (IM) injection of Ad26.Mos4.HIV vaccine 5\*10\^10 viral particles (vp) at Weeks 0 and 12 (- 1 week/ + 3 weeks), followed by Ad26.Mos4.HIV vaccine 5\*10\^10 vp + Clade C glycoprotein 140 vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) IM injection at Weeks 24 (- 1 week/ + 3 weeks) and 48 (- 1 week/ + 3 weeks). Participants who received all 4 vaccinations and were negative for HIV infection at Week 72 and consented separately for an optional long-term extension (LTE) phase after Week 72 and were followed up until Week 216 (for participants who did not enter late boost vaccination phase) and up to any day between Week 188 to Week 208 for those who entered late boost vaccination phase. | 26 |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 Participants in the main study received single IM injection of Ad26.Mos4.HIV vaccine 5\*10\^10 vp at Weeks 0 and 12 (- 1 week/ + 3 weeks), followed by Ad26.Mos4.HIV vaccine 5\*10\^10 vp + combination of Mosaic gp140 and Clade C gp140 containing 125 micrograms (mcg) of Clade C gp140 and 125 mcg Mosaic gp140 mixed with adjuvant (aluminum phosphate) IM injection at Weeks 24 (- 1 week/ + 3 weeks) and 48 (- 1 week/ + 3 weeks). Participants who received all 4 vaccinations and were negative for HIV infection at Week 72 consented separately for an optional long-term extension (LTE) phase after Week 72 and were followed up until Week 216 (for participants who did not enter late boost vaccination phase) and up to any day between Week 188 to Week 208 for those who entered late boost vaccination phase. | 100 |
| Group 3 Main Study: Placebo Participants received a single IM injection of placebo matching to Ad26.Mos4.HIV at Weeks 0 and 12 (- 1 week/ + 3 weeks), followed by placebo injections matching to AD26.Mos4.HIV and matching to Clade C + Mosaic gp140 at Weeks 24 (- 1 week/ + 3 weeks) and 48 (- 1 week/ + 3 weeks). | 26 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Late Boost Vaccination (Week 192 - 288) | Adverse Event | 0 | 0 | 0 | 0 | 1 |
| Late Boost Vaccination (Week 192 - 288) | Lost to Follow-up | 0 | 0 | 0 | 2 | 1 |
| Long-term Extension (Week 72 - 216) | Adverse Event | 0 | 1 | 0 | 0 | 0 |
| Long-term Extension (Week 72 - 216) | Lost to Follow-up | 2 | 8 | 0 | 0 | 0 |
| Long-term Extension (Week 72 - 216) | Withdrawal by Subject | 0 | 4 | 0 | 0 | 0 |
| Main Study (Week 0 up to Week 72) | Adverse Event | 1 | 0 | 0 | 0 | 0 |
| Main Study (Week 0 up to Week 72) | Lost to Follow-up | 4 | 1 | 2 | 0 | 0 |
| Main Study (Week 0 up to Week 72) | Other | 0 | 1 | 0 | 0 | 0 |
| Main Study (Week 0 up to Week 72) | Pregnancy | 0 | 2 | 0 | 0 | 0 |
| Main Study (Week 0 up to Week 72) | Randomized but not vaccinated | 0 | 3 | 0 | 0 | 0 |
| Main Study (Week 0 up to Week 72) | Withdrawal by Subject | 2 | 9 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3 Main Study: Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 28.7 years STANDARD_DEVIATION 7.07 | 31.8 years STANDARD_DEVIATION 8.09 | 30.7 years STANDARD_DEVIATION 10.11 | 31.1 years STANDARD_DEVIATION 8.34 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 4 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 92 Participants | 22 Participants | 138 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 7 Participants | 2 Participants | 11 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants | 38 Participants | 9 Participants | 57 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 8 Participants | 3 Participants | 13 Participants |
| Race/Ethnicity, Customized White | 12 Participants | 47 Participants | 12 Participants | 71 Participants |
| Region of Enrollment KENYA | 1 Participants | 4 Participants | 0 Participants | 5 Participants |
| Region of Enrollment RWANDA | 7 Participants | 26 Participants | 7 Participants | 40 Participants |
| Region of Enrollment UNITED STATES | 18 Participants | 70 Participants | 19 Participants | 107 Participants |
| Sex: Female, Male Female | 16 Participants | 59 Participants | 15 Participants | 90 Participants |
| Sex: Female, Male Male | 10 Participants | 41 Participants | 11 Participants | 62 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 100 | 0 / 26 | 0 / 41 | 0 / 13 |
| other Total, other adverse events | 25 / 26 | 96 / 100 | 25 / 26 | 38 / 41 | 9 / 13 |
| serious Total, serious adverse events | 1 / 26 | 2 / 100 | 0 / 26 | 1 / 41 | 3 / 13 |
Outcome results
Primary
Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 192
Geometric mean of Env Mos 1 specific binding Abs response at Week 192 were assessed using ELISA.
Time frame: Week 192
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 192 | 4044.7 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 192 | 3398.9 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 192 | 6816.4 ELISA units/milliliter (EU/mL) |
| Group 2b: LTE Then LB: Placebo (Previously in Group 2 of Main Study) | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 192 | 5125.0 ELISA units/milliliter (EU/mL) |
Primary
Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 193
Geometric Mean of Env Mos 1 specific binding Abs response at Week 193 were assessed using ELISA.
Time frame: Week 193
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 193 | 28412.2 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 193 | 3652.9 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 193 | 46851.6 ELISA units/milliliter (EU/mL) |
| Group 2b: LTE Then LB: Placebo (Previously in Group 2 of Main Study) | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 193 | 4505.3 ELISA units/milliliter (EU/mL) |
Primary
Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 196
Geometric mean of Env Mos 1 specific binding Abs response at Week 196 were assessed using ELISA.
Time frame: Week 196
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 196 | 169017.3 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 196 | 3438.1 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 196 | 174004.6 ELISA units/milliliter (EU/mL) |
| Group 2b: LTE Then LB: Placebo (Previously in Group 2 of Main Study) | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 196 | 5153.9 ELISA units/milliliter (EU/mL) |
Primary
Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 204
Geometric mean of Env Mos 1 specific binding Abs response at Week 204 were assessed using ELISA.
Time frame: Week 204
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 204 | 65259.8 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 204 | 3440.8 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 204 | 74715.2 ELISA units/milliliter (EU/mL) |
| Group 2b: LTE Then LB: Placebo (Previously in Group 2 of Main Study) | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 204 | 5303.2 ELISA units/milliliter (EU/mL) |
Primary
Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 216
Geometric mean of Env Mos 1 specific binding Abs response at Week 216 were assessed using ELISA.
Time frame: Week 216
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 216 | 27307.4 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 216 | 3237.3 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 216 | 43831.8 ELISA units/milliliter (EU/mL) |
| Group 2b: LTE Then LB: Placebo (Previously in Group 2 of Main Study) | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 216 | 5029.6 ELISA units/milliliter (EU/mL) |
Primary
Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 240
Geometric mean of Env Mos 1 specific binding Abs response at Week 240 were assessed using ELISA.
Time frame: Week 240
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 240 | 18223.4 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 240 | 3031.1 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 240 | 25693.2 ELISA units/milliliter (EU/mL) |
| Group 2b: LTE Then LB: Placebo (Previously in Group 2 of Main Study) | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 240 | 4491.1 ELISA units/milliliter (EU/mL) |
Primary
Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 288
Geometric mean of Env Mos 1 specific binding Abs response at Week 288 were assessed using ELISA.
Time frame: Week 288
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 288 | 18799.1 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 288 | 4742.3 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 288 | 15757.0 ELISA units/milliliter (EU/mL) |
| Group 2b: LTE Then LB: Placebo (Previously in Group 2 of Main Study) | Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 288 | 3933.1 ELISA units/milliliter (EU/mL) |
Primary
Late-boost (LB) Vaccination Phase: Number of Participants Who Discontinued Study Due to AEs
Number of participants who discontinued study due to AEs were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment.
Time frame: From Week 188 up to end of study (Week 288)
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Number of Participants Who Discontinued Study Due to AEs | 0 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Number of Participants Who Discontinued Study Due to AEs | 1 Participants |
Primary
Late-boost (LB) Vaccination Phase: Number of Participants With AESIs of HIV Infection Up to End of Study
Number of participants with AESIs up to the end of the study were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. AESIs (including potential AESIs) are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. AESIs (including potential AESIs) must be reported to the sponsor within 24 hours of awareness irrespective of seriousness (i.e, serious and nonserious AEs) or causality. Confirmed HIV infection was considered an AESI.
Time frame: From Week 188 up to end of study (Week 288)
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Number of Participants With AESIs of HIV Infection Up to End of Study | 0 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Number of Participants With AESIs of HIV Infection Up to End of Study | 2 Participants |
Primary
Late-boost (LB) Vaccination Phase: Number of Participants With AESIs of Thrombosis With Thrombocytopenia Syndrome (TTS)
Number of participants with AESIs of TTS were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. AESIs must be reported to the sponsor within 24 hours of awareness irrespective of seriousness (i.e, serious and nonserious AEs) or causality. Thrombotic events and/or thrombocytopenia were considered as AESIs.
Time frame: Up to 6 months post late boost vaccination (up to any day from Day 1317 to Day 1639) (late boost vaccination ranged from Day 1317 to 1457)
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Number of Participants With AESIs of Thrombosis With Thrombocytopenia Syndrome (TTS) | 0 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Number of Participants With AESIs of Thrombosis With Thrombocytopenia Syndrome (TTS) | 0 Participants |
Primary
Late-boost (LB) Vaccination Phase: Number of Participants With Serious Adverse Events (SAEs)
Number of participants with SAEs were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Time frame: From Week 188 up to end of study (Week 288)
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
Primary
Late-boost (LB) Vaccination Phase: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post Late Boost Vaccination
Number of participants with solicited local and systemic AEs for 7 days post late boost vaccination were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Solicited AEs were precisely local and systemic events for which the participant is specifically questioned and symptoms of which were noted by participant in their diary. Solicited local AEs included injection site pain/tenderness, erythema, and swelling/induration at the study vaccine injection site. Solicited systemic AEs included fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills.
Time frame: Up to 7 days post late boost vaccination (up to any day from Day 1317 to Day 1464) (late boost vaccination ranged from Day 1317 to 1457)
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post Late Boost Vaccination | 37 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post Late Boost Vaccination | 9 Participants |
Primary
Late-boost (LB) Vaccination Phase: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post Late Boost Vaccination
Number of participants with unsolicited AEs for 28 post late boost vaccination were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: Up to 28 days post late boost vaccination (up to any day from Day 1317 to Day 1485) (late boost vaccination ranged from Day 1317 to 1457)
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post Late Boost Vaccination | 11 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post Late Boost Vaccination | 4 Participants |
Primary
Main Study and LTE Study: Number of Participants With Adverse Events of Special Interest (AESIs)
Number of participants with adverse events of special interest (AESIs) were reported. As planned, confirmed HIV infection was the only event assessed as an AESI. AESIs (including potential AESIs) are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. AESIs (including potential AESIs) must be reported to the sponsor within 24 hours of awareness irrespective of seriousness (that is, serious and nonserious AEs) or causality.
Time frame: From Baseline (Day 1) up to Week 216
Population: FAS: all participants who were randomized and received at least 1 dose of study vaccine in main study and continued in LTE and did not enter late boost vaccination phase. Due to change in planned analysis, safety data for main study and LTE were combined for Groups 1 and 2 as LTE was a follow-up for participants who were in main study in Groups 1 and 2; no intervention was given in LTE. As both phases involved same participants in continued monitoring, data reflects ongoing safety assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study and LTE Study: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study and LTE Study: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Group 3: Placebo | Main Study and LTE Study: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
Primary
Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28
Geometric mean of Env Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 specific binding Abs responses were assessed using ELISA.
Time frame: Week 28
Population: PPI set included participants who received at least first 3 vaccines, as per protocol, had at least one measured post dose blood sample collected and were not diagnosed with HIV during study. Samples taken post Week 48 from participants in PPI set who missed or did not receive 4th vaccine in protocol specified time window (+/- 2 weeks) were excluded from analysis. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28 | Clade C (C97ZA.012) | 65644.1 ELISA units/milliliter (EU/mL) |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28 | Clade C (Con C) | 149924.9 ELISA units/milliliter (EU/mL) |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28 | Clade A (92UG037.1) | 99731.9 ELISA units/milliliter (EU/mL) |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28 | Clade B (1990a) | 67190.3 ELISA units/milliliter (EU/mL) |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28 | Mos 1 | 69234.2 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28 | Clade C (Con C) | 130235.2 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28 | Clade A (92UG037.1) | 88412.7 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28 | Clade B (1990a) | 71067.3 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28 | Clade C (C97ZA.012) | 54942.6 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28 | Mos 1 | 73780 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28 | Mos 1 | 39.1 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28 | Clade C (C97ZA.012) | 98.4 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28 | Clade A (92UG037.1) | 312.5 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28 | Clade C (Con C) | 333.3 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28 | Clade B (1990a) | 94.4 ELISA units/milliliter (EU/mL) |
Primary
Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52
Geometric mean of Env Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 specific binding Abs responses were assessed using ELISA.
Time frame: Week 52
Population: PPI set was used in this analysis. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed for specified categories.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52 | Clade C (C97ZA.012) | 92936.2 ELISA units/milliliter (EU/mL) |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52 | Clade C (Con C) | 155117.3 ELISA units/milliliter (EU/mL) |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52 | Clade A (92UG037.1) | 104042.2 ELISA units/milliliter (EU/mL) |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52 | Clade B (1990a) | 77042.3 ELISA units/milliliter (EU/mL) |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52 | Mos 1 | 79595 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52 | Clade C (Con C) | 237501.1 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52 | Clade A (92UG037.1) | 139725.1 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52 | Clade B (1990a) | 133424.3 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52 | Clade C (C97ZA.012) | 110083.7 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52 | Mos 1 | 137520.1 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52 | Mos 1 | 39.1 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52 | Clade C (C97ZA.012) | 78.1 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52 | Clade A (92UG037.1) | 312.5 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52 | Clade C (Con C) | 323.1 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52 | Clade B (1990a) | 94.3 ELISA units/milliliter (EU/mL) |
Primary
Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72
Geometric mean of Env Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 specific binding Abs responses were assessed using ELISA.
Time frame: Week 72
Population: PPI set was used in this analysis. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed for specified categories.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72 | Clade C (C97ZA.012) | 18236.1 ELISA units/milliliter (EU/mL) |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72 | Clade C (Con C) | 44505.6 ELISA units/milliliter (EU/mL) |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72 | Clade A (92UG037.1) | 33049.4 ELISA units/milliliter (EU/mL) |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72 | Clade B (1990a) | 20625 ELISA units/milliliter (EU/mL) |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72 | Mos 1 | 16861.6 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72 | Clade C (Con C) | 57596.5 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72 | Clade A (92UG037.1) | 39174.4 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72 | Clade B (1990a) | 33177.5 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72 | Clade C (C97ZA.012) | 18857.2 ELISA units/milliliter (EU/mL) |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72 | Mos 1 | 25161.6 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72 | Mos 1 | 40.9 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72 | Clade C (C97ZA.012) | 83.1 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72 | Clade A (92UG037.1) | 312.5 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72 | Clade C (Con C) | 342 ELISA units/milliliter (EU/mL) |
| Group 3: Placebo | Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72 | Clade B (1990a) | 99.1 ELISA units/milliliter (EU/mL) |
Primary
Main Study: Number of Participants Who Discontinued Study Vaccination Due to AEs
Number of participants who discontinued study vaccination due to AEs were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment.
Time frame: From Baseline (Day 1) up to Week 72
Population: FAS included all participants who were randomized and who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Number of Participants Who Discontinued Study Vaccination Due to AEs | 1 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Number of Participants Who Discontinued Study Vaccination Due to AEs | 0 Participants |
| Group 3: Placebo | Main Study: Number of Participants Who Discontinued Study Vaccination Due to AEs | 0 Participants |
Primary
Main Study: Number of Participants With Serious Adverse Events (SAEs)
Number of participants with SAEs were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Time frame: From Baseline (Day 1) up to Week 72
Population: FAS included all participants who were randomized and who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Group 3: Placebo | Main Study: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
Primary
Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 1
Number of participants with solicited local and systemic AEs for 7 days post-vaccination 1 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Solicited AEs were precisely local and systemic events for which the participant is specifically questioned and symptoms of which were noted by participant in their diary. Solicited local AEs included injection site pain/tenderness, erythema, and swelling/induration at the study vaccine injection site. Solicited systemic AEs included fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills.
Time frame: Up to 7 days post-vaccination 1 on Day 1 (up to Day 8)
Population: Full analysis set (FAS) included all participants who were randomized and who received at least one dose of study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 1 | Solicited local AE | 21 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 1 | Solicited systemic AE | 20 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 1 | Solicited local AE | 78 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 1 | Solicited systemic AE | 80 Participants |
| Group 3: Placebo | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 1 | Solicited local AE | 6 Participants |
| Group 3: Placebo | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 1 | Solicited systemic AE | 16 Participants |
Primary
Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 2
Number of participants with solicited local and systemic AEs for 7 days post-vaccination 2 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Solicited AEs were precisely local and systemic events for which the participant is specifically questioned and symptoms of which were noted by participant in their diary. Solicited local AEs included injection site pain/tenderness, erythema, and swelling/induration at the study vaccine injection site. Solicited systemic AEs included fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills.
Time frame: Up to 7 days post vaccination 2 (up to any day from Day 78 to Day 113) (vaccination 2 ranged from Day 78 to 106)
Population: FAS included all participants who were randomized and who received at least one dose of study vaccine. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 2 | Solicited local AE | 19 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 2 | Solicited systemic AE | 15 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 2 | Solicited local AE | 66 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 2 | Solicited systemic AE | 58 Participants |
| Group 3: Placebo | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 2 | Solicited local AE | 5 Participants |
| Group 3: Placebo | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 2 | Solicited systemic AE | 13 Participants |
Primary
Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 3
Number of participants with solicited local and systemic AEs for 7 days post-vaccination 3 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Solicited AEs were precisely local and systemic events for which the participant is specifically questioned and symptoms of which were noted by participant in their diary. Solicited local AEs included injection site pain/tenderness, erythema, and swelling/induration at the study vaccine injection site. Solicited systemic AEs included fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills.
Time frame: Up to 7 days post vaccination 3 (up to any day from Day 162 to Day 197) (vaccination 3 ranged from Day 162 to 190)
Population: FAS included all participants who were randomized and who received at least one dose of study vaccine. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 3 | Solicited local AE | 18 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 3 | Solicited systemic AE | 10 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 3 | Solicited local AE | 73 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 3 | Solicited systemic AE | 55 Participants |
| Group 3: Placebo | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 3 | Solicited local AE | 12 Participants |
| Group 3: Placebo | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 3 | Solicited systemic AE | 8 Participants |
Primary
Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 4
Number of participants with solicited local and systemic AEs for 7 days post-vaccination 4 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Solicited AEs were precisely local and systemic events for which the participant is specifically questioned and symptoms of which were noted by participant in their diary. Solicited local AEs included injection site pain/tenderness, erythema, and swelling/induration at the study vaccine injection site. Solicited systemic AEs included fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills.
Time frame: Up to 7 days post vaccination 4 (up to any day from Day 330 to Day 365) (vaccination 4 ranged from Day 330 to 358)
Population: FAS included all participants who were randomized and who received at least one dose of study vaccine. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 4 | Solicited local AE | 13 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 4 | Solicited systemic AE | 11 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 4 | Solicited local AE | 70 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 4 | Solicited systemic AE | 53 Participants |
| Group 3: Placebo | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 4 | Solicited local AE | 7 Participants |
| Group 3: Placebo | Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 4 | Solicited systemic AE | 6 Participants |
Primary
Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 1
Number of participants with unsolicited AEs for 28 days post-vaccination 1 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: Up to 28 days post-vaccination 1 on Day 1 (Up to Day 29)
Population: FAS included all participants who were randomized and who received at least one dose of study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 1 | 8 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 1 | 40 Participants |
| Group 3: Placebo | Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 1 | 12 Participants |
Primary
Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 2
Number of participants with unsolicited AEs for 28 days post-vaccination 2 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: Up to 28 days post vaccination 2 (up to any day from Day 78 to Day 134) (vaccination 2 ranged from Day 78 to 106)
Population: FAS included all participants who were randomized and who received at least one dose of study vaccine. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 2 | 6 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 2 | 35 Participants |
| Group 3: Placebo | Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 2 | 7 Participants |
Primary
Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 3
Number of participants with unsolicited AEs for 28 days post-vaccination 3 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: Up to 28 days post vaccination 3 (up to any day from Day 162 to Day 218) (vaccination 3 ranged from Day 162 to 190)
Population: FAS included all participants who were randomized and who received at least one dose of study vaccine. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 3 | 5 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 3 | 38 Participants |
| Group 3: Placebo | Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 3 | 8 Participants |
Primary
Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 4
Number of participants with unsolicited AEs for 28 days post-vaccination 4 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: Up to 28 days post vaccination 4 (up to any day from Day 330 to Day 358) (vaccination 4 ranged from Day 330 to 358)
Population: FAS included all participants who were randomized and who received at least one dose of study vaccine. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 4 | 3 Participants |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 4 | 30 Participants |
| Group 3: Placebo | Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 4 | 5 Participants |
Primary
Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28
Percentage of responders for envelop (Env) Clade B (SC42261), Clade C (CH505TF), Clade A (9004S), Clade B (RHPA), Clade B (WITO), Clade C (1086C), Clade C (BF1266), CladeAE (conAE), Clade M(Con S)-specific binding antibody titers assessed using enzyme-linked immunosorbent assay (ELISA) were reported. The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline value less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value greater than or equal to (\>=) LLOQ.
Time frame: Week 28
Population: PPI set included participants who received at least first 3 vaccines, as per protocol, had at least one measured post dose blood sample collected and were not diagnosed with HIV during study. Samples taken post Week 48 from participants in PPI set who missed or did not receive 4th vaccine in protocol specified time window (+/- 2 weeks) were excluded from analysis. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade C (BF1266) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade B (RHPA) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade C (1086C) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade B (WITO) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade C (CH505TF) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade B (SC42261) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | CladeAE (conAE) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade A (9004S) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade M(Con S) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade B (RHPA) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade B (SC42261) | 100.0 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade C (CH505TF) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade A (9004S) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade B (WITO) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade C (1086C) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade C (BF1266) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | CladeAE (conAE) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade M(Con S) | 100 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade A (9004S) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade B (SC42261) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade C (BF1266) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade C (CH505TF) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade M(Con S) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade B (WITO) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade B (RHPA) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | CladeAE (conAE) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28 | Clade C (1086C) | 0 percentage of responders |
Primary
Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52
Percentage of responders for envelop (Env) Clade B (SC42261), Clade C (CH505TF), Clade A (9004S), Clade B (RHPA), Clade B (WITO), Clade C (1086C), Clade C (BF1266), CladeAE (conAE), Clade M(Con S)-specific binding antibody titers assessed using enzyme-linked immunosorbent assay (ELISA) were reported. The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline value less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value greater than or equal to (\>=) LLOQ.
Time frame: Week 52
Population: PPI set included participants who received at least first 3 vaccines, as per protocol, had at least one measured post dose blood sample collected and were not diagnosed with HIV during study. Samples taken post Week 48 from participants in PPI set who missed or did not receive 4th vaccine in protocol specified time window (+/- 2 weeks) were excluded from analysis. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade B (RHPA) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade M(Con S) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade C (1086C) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade B (WITO) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade B (SC42261) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | CladeAE (conAE) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade A (9004S) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade C (CH505TF) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade C (BF1266) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade B (WITO) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade B (SC42261) | 100.0 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade C (CH505TF) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade A (9004S) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade B (RHPA) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade C (1086C) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade C (BF1266) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | CladeAE (conAE) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade M(Con S) | 100 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade A (9004S) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade B (SC42261) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade C (BF1266) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade C (CH505TF) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade M(Con S) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade B (WITO) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade B (RHPA) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | CladeAE (conAE) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52 | Clade C (1086C) | 0 percentage of responders |
Primary
Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72
Percentage of responders for envelop (Env) Clade B (SC42261), Clade C (CH505TF), Clade A (9004S), Clade B (RHPA), Clade B (WITO), Clade C (1086C), Clade C (BF1266), CladeAE (conAE), Clade M(Con S)-specific binding antibody titers assessed using enzyme-linked immunosorbent assay (ELISA) were reported. The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline value less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value greater than or equal to (\>=) LLOQ.
Time frame: Week 72
Population: PPI set was used. Here, N (Number of participants analyzed): participants evaluable for this outcome measure and 'n' (number analyzed): number of participants analyzed for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade B (RHPA) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade M(Con S) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade C (1086C) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade B (WITO) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade B (SC42261) | 93.8 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | CladeAE (conAE) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade A (9004S) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade C (CH505TF) | 100 percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade C (BF1266) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade B (WITO) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade B (SC42261) | 94.7 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade C (CH505TF) | 96.1 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade A (9004S) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade B (RHPA) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade C (1086C) | 100 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade C (BF1266) | 98.7 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | CladeAE (conAE) | 97.4 percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade M(Con S) | 100 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade A (9004S) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade B (SC42261) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade C (BF1266) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade C (CH505TF) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade M(Con S) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade B (WITO) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade B (RHPA) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | CladeAE (conAE) | 0 percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72 | Clade C (1086C) | 0 percentage of responders |
Secondary
Late-boost (LB) Vaccination Phase: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol)
Percentage of Interferon (IFN)-Gamma PBMC responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) were planned to be reported.
Time frame: From Week 188 up to end of study (Week 288)
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit) was planned to be used. Per change in planned analysis, data was not collected and analyzed due to limited scientific merit in the interpretation of this outcome measure.
Secondary
Late-boost (LB) Vaccination Phase: Percentage of Participants With T-Cell Development
Percentage of participants with T-Cell Development were planned to be reported.
Time frame: From Week 188 up to end of study (Week 288)
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit) was planned to be used. Per change in planned analysis, data was not collected and analyzed due to limited scientific merit in the interpretation of this outcome measure.
Secondary
Late-boost (LB) Vaccination Phase: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3)
Percentage of responders for Env-specific binding Ab isotypes IgG1 and IgG3) were planned to be reported.
Time frame: From Week 188 up to end of study (Week 288)
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit). Per change in planned analysis, data was not collected and analyzed due to limited scientific merit in the interpretation of this outcome measure.
Secondary
Late-boost (LB) Vaccination Phase: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140)
Percentage of responders for Env-specific functional antibody response (Env ADCP gp140) were planned to be reported.
Time frame: From Week 188 up to end of study (Week 288)
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit). Per change in planned analysis, data was not collected and analyzed due to limited scientific merit in the interpretation of this outcome measure.
Secondary
Late-boost (LB) Vaccination Phase: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses
Percentage of responders of Env-specific nAbs for tier 1 viruses were planned to be reported.
Time frame: From Week 188 up to end of study (Week 288)
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit). Per change in planned analysis, data was not collected and analyzed due to limited scientific merit in the interpretation of this outcome measure.
Secondary
Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality
Percentage of responders with CD4+ and CD8+ T-cell functionality (cells producing IFN-gamma and /or IL-2) were reported. Intracellular cytokine staining (ICS) was performed to examine the type of T-cell responding to vaccination. Responder definition was based on the Fisher's exact text between cytokine producing cells and non-producing cells in stimulated versus non-stimulated conditions.
Time frame: Weeks 192 and 196
Population: LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed for specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos2S gp120 IFNg+ or IL2+ (%): Week 192 | 30.4 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:Any HIV IFNg+ or IL2+ (%): Week 192 | 82.6 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:Any HIV IFNg+ or IL2+ (%): Week 196 | 91.3 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:Any MOS1 Env IFNg+ or IL2+ (%): Week 192 | 73.9 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:Any MOS1 Env IFNg+ or IL2+ (%): Week 196 | 91.3 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:Any MOS2 Env IFNg+ or IL2+ (%): Week 192 | 65.2 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:Any MOS2 Env IFNg+ or IL2+ (%): Week 196 | 73.9 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos1 gp120 IFNg+ or IL2+ (%): Week 192 | 73.9 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos1 gp120 IFNg+ or IL2+ (%): Week 196 | 91.3 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos1 gp41 IFNg+ or IL2+ (%): Week 192 | 39.1 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:Any Env IFNg+ or IL2+ (%): Week 196 | 91.3 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos2S gp120 IFNg+ or IL2+ (%): Week 196 | 34.8 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos2S gp41 IFNg+ or IL2+ (%): Week 192 | 17.4 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos2S gp41 IFNg+ or IL2+ (%): Week 196 | 17.4 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: POSITIVE CONTROL (CMV) IFNg+ or IL2+ (%): Week 192 | 52.2 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: POSITIVE CONTROL (CMV) IFNg+ or IL2+ (%): Week 196 | 50.0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos1 gp41 IFNg+ or IL2+ (%): Week 196 | 43.5 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos2 Gag IFNg+ or IL2+ (%): Week 192 | 21.7 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos2 Gag IFNg+ or IL2+ (%): Week 196 | 39.1 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos2 RNAseInt IFNg+ or IL2+ (%): Week 192 | 17.4 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos2 RNAseInt IFNg+ or IL2+ (%): Week 196 | 17.4 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos2S gp120 IFNg+ or IL2+ (%): Week 192 | 60.9 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos2S gp120 IFNg+ or IL2+ (%): Week 196 | 69.6 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos2S gp41 IFNg+ or IL2+ (%): Week 192 | 21.7 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos2S gp41 IFNg+ or IL2+ (%): Week 196 | 43.5 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +: POSITIVE CONTROL (CMV) IFNg+ or IL2+ (%): Week 192 | 52.2 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +: POSITIVE CONTROL (CMV) IFNg+ or IL2+ (%): Week 196 | 50.0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: Any HIV IFNg+ or IL2+ (%): Week 192 | 73.9 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: Any HIV IFNg+ or IL2+ (%): Week 196 | 73.9 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: Any MOS1 Env IFNg+ or IL2+ (%): Week 192 | 34.8 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: Any MOS1 Env IFNg+ or IL2+ (%): Week 196 | 43.5 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: Any MOS2 Env IFNg+ or IL2+ (%): Week 192 | 47.8 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: Any MOS2 Env IFNg+ or IL2+ (%): Week 196 | 47.8 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos1 gp120 IFNg+ or IL2+ (%): Week 192 | 17.4 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos1 gp120 IFNg+ or IL2+ (%): Week 196 | 26.1 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos1 gp41 IFNg+ or IL2+ (%): Week 192 | 17.4 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos1 gp41 IFNg+ or IL2+ (%): Week 196 | 21.7 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos2 Gag IFNg+ or IL2+ (%): Week 192 | 30.4 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos2 Gag IFNg+ or IL2+ (%): Week 196 | 30.4 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos2 RNAseInt IFNg+ or IL2+ (%): Week 192 | 34.8 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos2 RNAseInt IFNg+ or IL2+ (%): Week 196 | 34.8 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:Any Env IFNg+ or IL2+ (%): Week 192 | 82.6 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: Any MOS2 Env IFNg+ or IL2+ (%): Week 192 | 14.3 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:Any Env IFNg+ or IL2+ (%): Week 196 | 83.3 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos2S gp120 IFNg+ or IL2+ (%): Week 192 | 42.9 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:Any HIV IFNg+ or IL2+ (%): Week 192 | 57.1 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos2 RNAseInt IFNg+ or IL2+ (%): Week 192 | 14.3 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:Any HIV IFNg+ or IL2+ (%): Week 196 | 83.3 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos2S gp120 IFNg+ or IL2+ (%): Week 196 | 33.3 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:Any MOS1 Env IFNg+ or IL2+ (%): Week 192 | 57.1 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: Any MOS2 Env IFNg+ or IL2+ (%): Week 196 | 33.3 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:Any MOS1 Env IFNg+ or IL2+ (%): Week 196 | 83.3 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos2S gp41 IFNg+ or IL2+ (%): Week 192 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:Any MOS2 Env IFNg+ or IL2+ (%): Week 192 | 42.9 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos2 Gag IFNg+ or IL2+ (%): Week 192 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:Any MOS2 Env IFNg+ or IL2+ (%): Week 196 | 33.3 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos2S gp41 IFNg+ or IL2+ (%): Week 196 | 16.7 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos1 gp120 IFNg+ or IL2+ (%): Week 192 | 57.1 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos1 gp120 IFNg+ or IL2+ (%): Week 192 | 14.3 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos1 gp120 IFNg+ or IL2+ (%): Week 196 | 83.3 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +: POSITIVE CONTROL (CMV) IFNg+ or IL2+ (%): Week 192 | 57.1 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos1 gp41 IFNg+ or IL2+ (%): Week 192 | 14.3 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:Any Env IFNg+ or IL2+ (%): Week 192 | 57.1 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos2S gp120 IFNg+ or IL2+ (%): Week 192 | 14.3 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +: POSITIVE CONTROL (CMV) IFNg+ or IL2+ (%): Week 196 | 80.0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos2S gp120 IFNg+ or IL2+ (%): Week 196 | 16.7 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos1 gp120 IFNg+ or IL2+ (%): Week 196 | 16.7 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos2S gp41 IFNg+ or IL2+ (%): Week 192 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: Any HIV IFNg+ or IL2+ (%): Week 192 | 28.6 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos2S gp41 IFNg+ or IL2+ (%): Week 196 | 16.7 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos2 Gag IFNg+ or IL2+ (%): Week 196 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: POSITIVE CONTROL (CMV) IFNg+ or IL2+ (%): Week 192 | 71.4 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: Any HIV IFNg+ or IL2+ (%): Week 196 | 33.3 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: POSITIVE CONTROL (CMV) IFNg+ or IL2+ (%): Week 196 | 80.0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos1 gp41 IFNg+ or IL2+ (%): Week 192 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos1 gp41 IFNg+ or IL2+ (%): Week 196 | 33.3 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: Any MOS1 Env IFNg+ or IL2+ (%): Week 192 | 14.3 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos2 Gag IFNg+ or IL2+ (%): Week 192 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos2 RNAseInt IFNg+ or IL2+ (%): Week 196 | 16.7 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos2 Gag IFNg+ or IL2+ (%): Week 196 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: Any MOS1 Env IFNg+ or IL2+ (%): Week 196 | 16.7 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos2 RNAseInt IFNg+ or IL2+ (%): Week 192 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: J Mos1 gp41 IFNg+ or IL2+ (%): Week 196 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:J Mos2 RNAseInt IFNg+ or IL2+ (%): Week 196 | 16.7 Percentage of responders |
Secondary
Long-term Extension (LTE) Phase: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol)
Percentage of Interferon (IFN)-Gamma PBMC responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) was planned to be reported.
Time frame: From Week 72 up to Week 216
Population: LTE analysis set included all participants in the PPI Analysis set who were enrolled in the LTE phase of the study. Participants who received the late-boost vaccination were excluded from Week 192 onwards. Per change in planned analysis, data was not collected and analyzed due to limited scientific merit in the interpretation of this outcome measure.
Secondary
Long-term Extension (LTE) Phase: Percentage of Participants With T-Cell Development
Percentage of participants with T-Cell development were planned to be reported.
Time frame: From Week 72 up to Week 216
Population: LTE analysis set included all participants in the PPI Analysis set who were enrolled in the LTE phase of the study. Participants who received the late-boost vaccination were excluded from Week 192 onwards. Per change in planned analysis, data was not collected and analyzed due to limited scientific merit in the interpretation of this outcome measure.
Secondary
Long-term Extension (LTE) Phase: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3)
Percentage of responders for Env-specific binding Ab isotypes IgG1 and IgG3) were planned to be reported.
Time frame: From Week 72 up to Week 216
Population: LTE analysis set included all participants in the PPI Analysis set who were enrolled in the LTE phase of the study. Participants who received the late-boost vaccination were excluded from Week 192 onwards. Per change in planned analysis, data was not collected and analyzed due to limited scientific merit in the interpretation of this outcome measure.
Secondary
Long-term Extension (LTE) Phase: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140)
Percentage of responders for Env-specific functional antibody response (Env ADCP gp140) were planned to be reported.
Time frame: From Week 72 up to Week 216
Population: LTE analysis set included all participants in the PPI Analysis set who were enrolled in the LTE phase of the study. Participants who received the late-boost vaccination were excluded from Week 192 onwards. Per change in planned analysis, data was not collected and analyzed due to limited scientific merit in the interpretation of this outcome measure.
Secondary
Long-term Extension (LTE) Phase: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses
Percentage of responders of Env-specific nAbs for tier 1 viruses were planned to be reported.
Time frame: From Week 72 to Week 216
Population: LTE analysis set included all participants in the PPI Analysis set who were enrolled in the LTE phase of the study. Participants who received the late-boost vaccination were excluded from Week 192 onwards. Per change in planned analysis, data was not collected and analyzed due to limited scientific merit in the interpretation of this outcome measure.
Secondary
Long-term Extension (LTE) Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality
Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality (cells Producing IFN-Gamma and/or Interleukin \[IL-2\]) were planned to be reported. Intracellular cytokine staining (ICS) was performed to examine the type of T-cell responding to vaccination. Responder definition was based on the Fisher's exact text between cytokine producing cells and non-producing cells in stimulated versus non-stimulated conditions.
Time frame: From Week 72 up to Week 216
Population: LTE analysis set included all participants in the PPI Analysis set who were enrolled in the LTE phase of the study. Participants who received the late-boost vaccination were excluded from Week 192 onwards. Per change in planned analysis, data was not collected and analyzed due to limited scientific merit in the interpretation of this outcome measure.
Secondary
Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol)
Percentage of IFN-gamma PBMC responders to mosaic and PTE peptide pools of Env/Gag/Pol as assessed by ELISpot was reported. The response was defined as post-baseline value \>P95 if baseline \<P95 or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=P95.
Time frame: Weeks 28, 52, and 72
Population: PPI set was used in this analysis. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed for specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Clinical PTE): Week 28 | 90.5 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos2): Week 72 | 70.6 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos1): Week 52 | 58.8 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos1): Week 52 | 94.1 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos2): Week 52 | 94.1 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos1): Week 72 | 47.1 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos1): Week 72 | 52.9 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos2): Week 28 | 81.0 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos2): Week 28 | 76.2 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Clinical PTE): Week 52 | 82.4 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos2): Week 72 | 70.6 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos2): Week 52 | 75.0 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos2): Week 72 | 58.8 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos1): Week 52 | 52.9 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Clinical PTE): Week 72 | 76.5 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos2): Week 52 | 75.0 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos1): Week 28 | 52.4 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos1): Week 28 | 90.5 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos1): Week 72 | 85.7 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Clinical PTE) : Week 72 | 41.2 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Clinical PTE): Week 52 | 82.4 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos2): Week 28 | 61.9 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Clinical PTE) : Week 52 | 41.2 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Clinical PTE): Week 72 | 76.5 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Clinical PTE): Week 28 | 76.2 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Clinical PTE) : Week 28 | 52.4 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos1): Week 28 | 76.2 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos2): Week 72 | 47.0 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos1): Week 52 | 84.1 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Clinical PTE): Week 28 | 82.0 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Clinical PTE): Week 52 | 87.8 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Clinical PTE): Week 72 | 84.3 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Clinical PTE): Week 28 | 77.5 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Clinical PTE): Week 52 | 86.6 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Clinical PTE): Week 72 | 83.1 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos1): Week 28 | 75.3 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos1): Week 52 | 78.0 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos1): Week 72 | 73.5 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos2): Week 28 | 83.1 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos2): Week 52 | 85.4 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos2): Week 72 | 80.7 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos1): Week 72 | 85.9 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos2): Week 28 | 88.8 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos2): Week 52 | 87.8 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos2): Week 72 | 86.7 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Clinical PTE) : Week 28 | 31.5 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Clinical PTE) : Week 52 | 32.9 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Clinical PTE) : Week 72 | 26.5 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos1): Week 28 | 56.2 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos1): Week 52 | 51.2 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos1): Week 72 | 48.2 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos2): Week 28 | 60.7 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos2): Week 52 | 52.4 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos1): Week 28 | 85.4 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos2): Week 72 | 4.8 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Clinical PTE): Week 72 | 0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos1): Week 72 | 4.8 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Clinical PTE) : Week 28 | 0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Clinical PTE): Week 52 | 4.3 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos2): Week 72 | 0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Clinical PTE) : Week 52 | 0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Clinical PTE): Week 28 | 4.0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos2): Week 52 | 8.7 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Clinical PTE) : Week 72 | 0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Clinical PTE): Week 72 | 4.8 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos2): Week 28 | 8.0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos1): Week 28 | 4.0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos2): Week 52 | 17.4 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos2): Week 28 | 4.0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Clinical PTE): Week 52 | 4.3 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos2): Week 72 | 9.5 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos1): Week 52 | 13.0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos1): Week 72 | 10.0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos1): Week 72 | 0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Gag pep pool (Mos1): Week 52 | 4.3 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos2): Week 28 | 4.0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos1): Week 52 | 17.4 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Clinical PTE): Week 28 | 0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos2): Week 52 | 8.7 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg Pol pep pool (Mos1): Week 28 | 8.0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol) | HIV IFNg ENV pep pool (Mos1): Week 28 | 4.0 Percentage of Responders |
Secondary
Main Study: Percentage of Participants With T-Cell Development
Percentage of participants with T-Cell development were planned to be reported.
Time frame: From Baseline (Day 1) up to Week 72
Population: PPI set included participants who received at least first 3 vaccines, as per protocol, had at least one measured post dose blood sample collected and were not diagnosed with HIV during study. Samples taken post Week 48 from participants in PPI set who missed or did not receive 4th vaccine in protocol specified time window (+/- 2 weeks) were excluded from analysis. Due to change in planned analysis, data was not collected and analyzed as assay was not qualified.
Secondary
Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3)
Percentage of responders for Env-specific binding Ab isotypes (IgG1 and IgG3) for Clade C (ZA) as assessed using ELISA were reported. The response was defined as post-baseline value \>LLOQ if baseline \<LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=LLOQ. The LLOQs for this assay were 12.3 and 12.4 EC50 for IgG1 and IgG3, respectively. EC50= 50% effective concentration.
Time frame: Weeks 28, 52, and 72
Population: PPI set was used in this analysis. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed for specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-1 Ab: Week 28 | 65.0 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-1 Ab: Week 52 | 76.5 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-1 Ab: Week 72 | 76.5 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-3 Ab: Week 28 | 60.0 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-3 Ab: Week 52 | 75.0 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-3 Ab: Week 72 | 23.5 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-3 Ab: Week 72 | 36.6 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-1 Ab: Week 28 | 76.7 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-3 Ab: Week 28 | 75.0 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-3 Ab: Week 52 | 73.2 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-1 Ab: Week 52 | 75.6 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-1 Ab: Week 72 | 66.3 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-1 Ab: Week 52 | 0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-1 Ab: Week 72 | 0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-3 Ab: Week 72 | 14.3 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-3 Ab: Week 28 | 8.7 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-1 Ab: Week 28 | 0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3) | HIV ENV (gp140 T) clade C (ZA) IgG-3 Ab: Week 52 | 0 Percentage of Responders |
Secondary
Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140)
Percentage of responders for Env-specific functional antibody response (Env ADCP gp140) were reported. The response was defined as post-baseline value \> limit of detection (LOD) if baseline value \<LOD or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value \>=LOD. The lower limits of detection (LODs) for this assay were 5.16, 6.43, 6.49, 4.32 and 4.28 (phagocytic score) for Clade A (92UG037.1), Clade B (1990a), Clade C (Con C), Clade C (ZA), and Mos1, respectively.
Time frame: Weeks 28, 52, and 72 (Weeks 52 and 72 are only for HIV ENV [gp140 T sortA] C [ZA] F Ab)
Population: PPI set was used in this analysis. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed for specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 T sortA) (Mos1) F Ab: Week 28 | 100.0 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 T sortA) C (ZA) F Ab: Week 28 | 95.0 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 T sortA) C (ZA) F Ab: Week 72 | 100.0 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 M sortA) B (1990a) F Ab: Week 28 | 90.0 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 T sortA) C (ZA) F Ab: Week 52 | 100.0 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 M sortA) C (conC) F Ab: Week 28 | 85.0 Percentage of Responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 M sortA) A (92UG037) F Ab: Week 28 | 90.0 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 T sortA) (Mos1) F Ab: Week 28 | 100.0 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 M sortA) A (92UG037) F Ab: Week 28 | 94.4 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 M sortA) B (1990a) F Ab: Week 28 | 98.9 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 T sortA) C (ZA) F Ab: Week 28 | 100.0 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 M sortA) C (conC) F Ab: Week 28 | 91.1 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 T sortA) C (ZA) F Ab: Week 72 | 96.4 Percentage of Responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 T sortA) C (ZA) F Ab: Week 52 | 100.0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 T sortA) C (ZA) F Ab: Week 72 | 52.4 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 T sortA) C (ZA) F Ab: Week 52 | 13.0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 M sortA) A (92UG037) F Ab: Week 28 | 32.0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 M sortA) B (1990a) F Ab: Week 28 | 0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 M sortA) C (conC) F Ab: Week 28 | 0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 T sortA) (Mos1) F Ab: Week 28 | 36.0 Percentage of Responders |
| Group 3: Placebo | Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140) | HIV ENV (gp140 T sortA) C (ZA) F Ab: Week 28 | 8.0 Percentage of Responders |
Secondary
Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses
Percentage of responders of Env-specific nAbs for tier 1 viruses were reported. Viruses with a Tier 1 neutralization phenotype: Clade C: MW965 and 97ZA012, ZM233M, CE703010010, 2759058, ZM215F, SO431, CE704810053 were used. The response was defined as post-baseline value \>LLOQ.
Time frame: Weeks 28, 52, and 72 (only for Clade C [MW965])
Population: PPI set was used in this analysis. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed for specified timepoints. n=0 signifies no participant was available for the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (MW965): Week 28 | 100.0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (MW965): Week 52 | 100.0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (MW965) Week 72 | 100.0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (97ZA012): Week 28 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (97ZA012): Week 52 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (ZM233M): Week 28 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (ZM233M): Week 52 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (CE703010010): Week 28 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (CE703010010): Week 52 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (2759058): Week 28 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (2759058): Week 52 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (ZM215F): Week 28 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (ZM215F): Week 52 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (SO431): Week 28 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (SO431): Week 52 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (CE704810053): Week 28 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C(CE704810053): Week 52 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (2759058): Week 52 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (ZM233M): Week 52 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (SO431): Week 52 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (CE703010010): Week 28 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (ZM215F): Week 52 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (MW965): Week 28 | 100.0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (97ZA012): Week 52 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (CE704810053): Week 28 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (ZM233M): Week 28 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (ZM215F): Week 28 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (CE703010010): Week 52 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (MW965): Week 52 | 100.0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C(CE704810053): Week 52 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (MW965) Week 72 | 98.7 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (2759058): Week 28 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (97ZA012): Week 28 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (SO431): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (MW965): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (97ZA012): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (97ZA012): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses | Clade C (MW965): Week 52 | 0 Percentage of responders |
Secondary
Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality
Percentage of responders with CD4+ and CD8+ T-cell functionality (cells producing IFN-gamma and /or IL-2) were reported. Intracellular cytokine staining (ICS) was performed to examine the type of T-cell responding to vaccination. Responder definition was based on the Fisher's exact text between cytokine producing cells and non-producing cells in stimulated versus non-stimulated conditions.
Time frame: Weeks 28, 52, and 72
Population: PPI set was used in this analysis. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed for specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Gag pep pool ANY: Week 52 | 7.14 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 42.86 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 52 | 35.29 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 72 | 52.94 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 5.88 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 29.41 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 72 | 29.41 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 63.16 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 10.00 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 58.82 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 29.41 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 72 | 5.88 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 15.79 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 7.14 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 29.41 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 17.65 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 50.00 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 5.56 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 5.88 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 10.00 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 36.84 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 23.53 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 72 | 41.18 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 35.29 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 29.41 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 57.89 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 47.06 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 17.65 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 31.58 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 10.00 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 10.00 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 28 | 50.00 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 64.29 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +: HIV ENV gp120 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 50.00 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 72 | 41.18 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +: HIV ENV gp120 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 57.14 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 29.41 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 28 | 21.05 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +: HIV ENV gp120 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 29.41 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 40.00 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 42.86 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 40.00 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 23.53 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 15.79 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 52 | 64.29 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 21.43 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 57.14 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 5.88 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 28 | 36.84 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 17.65 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 28 | 10.00 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8+: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 52 | 29.41 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 29.41 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 72 | 17.65 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 10.53 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 11.76 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 28 | 50.00 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8+: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 5.88 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 15.79 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 29.41 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 52 | 64.29 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 20.00 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 28 | 73.68 Percentage of responders |
| Group 1: Ad26.Mos4.HIV + Clade C gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 52 | 70.59 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 28.05 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 52 | 58.23 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 5.95 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 28 | 21.84 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 23.94 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 28 | 8.33 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Gag pep pool ANY: Week 52 | 9.86 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 13.92 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 72 | 52.50 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 7.04 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 10.26 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 8.33 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 30.38 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 19.72 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 72 | 17.50 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 28 | 80.95 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 47.13 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 26.58 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 32.14 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 49.37 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 8.33 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 11.27 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 40.00 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 12.82 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 47.89 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 9.20 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 1.28 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 74.65 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 10.13 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 9.86 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 52 | 22.78 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 8.75 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +: HIV ENV gp120 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 80.95 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8+: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 25.00 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 11.76 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 28 | 82.14 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +: HIV ENV gp120 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 73.24 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 12.66 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 1.28 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 28 | 58.62 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 13.75 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 80.95 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8+: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 52 | 29.11 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 14.94 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 6.33 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 52 | 77.46 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 28 | 33.33 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 7.50 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +: HIV ENV gp120 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 69.23 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 69.23 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 9.20 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 2.38 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 52 | 77.46 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 27.50 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 47.62 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 21.84 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 72 | 69.23 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 72 | 26.25 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 22.78 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 7.04 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 43.66 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 17.50 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 72 | 1.28 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 21.79 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 29.89 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 13.75 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 19.23 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 30.38 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 1.28 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 53.57 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 20.00 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 72 | 69.23 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 29.89 Percentage of responders |
| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 31.03 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Gag pep pool ANY: Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4+: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +: HIV ENV gp120 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +: HIV ENV gp120 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +: HIV ENV gp120 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD4 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8+: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8+: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 Percentage of responders |
| Group 3: Placebo | Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality | CD8 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 Percentage of responders |