A Phase 1/2 interventional study of Ad26.Mos4.HIV and Clade C gp140 plus adjuvant in Healthy, sponsored by Janssen Vaccines & Prevention B.V.. Completed at 13 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Janssen Vaccines & Prevention B.V. · Phase 1/2, Interventional, and Prevention
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.
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.
Exclusion Criteria:
Participants will receive Ad26.Mos4.HIV vaccine at Week 0 and 12, followed by Ad26.Mos4.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 microgram (mcg) of total protein mixed with adjuvant (aluminium phosphate) at Week 24 and 48. Participants who receive all 4 vaccinations and are negative for HIV infection at Week 72 can consent to be included in a long-term extension (LTE) phase (approximately 3 years after Week 72).
Biological: Ad26.Mos4.HIV · Biological: Clade C gp140 plus adjuvant
Participants will receive Ad26.Mos4.HIV vaccine at Week 0 and 12; followed by Ad26.Mos4.HIV vaccine + combination of 125 mcg Mosaic gp140 and 125 mcg Clade C gp140 mixed with adjuvant (aluminum phosphate) at Week 24 and 48. Participants who receive all 4 vaccinations and are negative for HIV infection at Week 72 can consent to be included in a long-term extension (LTE) phase (approximately 3 years after Week 72).
Biological: Ad26.Mos4.HIV · Biological: Clade C gp140/Mosaic gp140 plus adjuvant
Participants will receive a single placebo injection at Weeks 0 and 12, followed by two placebo injections at Weeks 24 and 48.
Other: Placebo
Participants enrolled in the LTE phase will receive late boost vaccination Ad26.Mos4.HIV and bivalent gp140 within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, approximately 3 years after the 4th vaccination of the primary vaccination series).
Biological: Ad26.Mos4.HIV · Biological: gp140 HIV Bivalent Vaccine
Participants will receive placebo injection at Week 192 -4 weeks/+4 months, that is, approximately 3 years after the 4th vaccination of the primary vaccination series.
Other: Placebo
Ad26.Mos4.HIV at a dose of 5\*10\^10 viral particles (vp), administered intramuscularly.
Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 milliliter (mL) injection administered intramuscularly.
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.
Placebo Containing 0.9 percent normal saline, administered intramuscularly.
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).
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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])
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
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)
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)
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
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)
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
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
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)
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
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
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)
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
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
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
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
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
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)
| Milestone | Group 1 Main Study and LTE Phase: Ad26.Mos4.HIV + Clade C gp140 | Group 2 Main Study and LTE Phase: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3 Main Study: Placebo | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Group 2b: LTE Then Late-boost Placebo |
|---|---|---|---|---|---|
| Started | 26 | 103 | 26 | 0 | 0 |
| Vaccinated | 26 | 100 | 26 | 0 | 0 |
| Completed | 19 | 87 | 24 | 0 | 0 |
| Not completed | 7 | 16 | 2 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 4 | 1 | 2 | 0 | 0 |
| Withdrew: Pregnancy | 0 | 2 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 9 | 0 | 0 | 0 |
| Withdrew: Other | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Randomized but not vaccinated | 0 | 3 | 0 | 0 | 0 |
| Milestone | Group 1 Main Study and LTE Phase: Ad26.Mos4.HIV + Clade C gp140 | Group 2 Main Study and LTE Phase: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3 Main Study: Placebo | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Group 2b: LTE Then Late-boost Placebo |
|---|---|---|---|---|---|
| Started | 14 | 76 | 0 | 0 | 0 |
| Participants entering lte and did not receive late-boost (weeks 72-216) | 3 | 33 | 0 | 0 | 0 |
| Completed | 12 | 63 | 0 | 0 | 0 |
| Not completed | 2 | 13 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 2 | 8 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 4 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 | 0 |
| Milestone | Group 1 Main Study and LTE Phase: Ad26.Mos4.HIV + Clade C gp140 | Group 2 Main Study and LTE Phase: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3 Main Study: Placebo | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Group 2b: LTE Then Late-boost Placebo |
|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 41 | 13 |
| Completed | 0 | 0 | 0 | 39 | 11 |
| Not completed | 0 | 0 | 0 | 2 | 2 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 2 | 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.
| Participants | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| Solicited local AE | 21 | 78 | 6 |
| Solicited systemic AE | 20 | 80 | 16 |
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.
| Participants | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| Solicited local AE | 19 | 66 | 5 |
| Solicited systemic AE | 15 | 58 | 13 |
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.
| Participants | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| Solicited local AE | 18 | 73 | 12 |
| Solicited systemic AE | 10 | 55 | 8 |
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.
| Participants | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| Solicited local AE | 13 | 70 | 7 |
| Solicited systemic AE | 11 | 53 | 6 |
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.
| Participants | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 1 | 8 | 40 | 12 |
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.
| Participants | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 2 | 6 | 35 | 7 |
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.
| Participants | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 3 | 5 | 38 | 8 |
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.
| Participants | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 4 | 3 | 30 | 5 |
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.
| Participants | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| Main Study: Number of Participants Who Discontinued Study Vaccination Due to AEs | 1 | 0 | 0 |
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.
| Participants | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| Main Study: Number of Participants With Serious Adverse Events (SAEs) | 0 | 0 | 0 |
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.
| Participants | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3 Main Study: Placebo |
|---|---|---|---|
| Main Study and LTE Study: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 | 0 | 0 |
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.
| Participants | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Group 2b: LTE Then Late-boost Placebo |
|---|---|---|
| Late-boost (LB) Vaccination Phase: Number of Participants Who Discontinued Study Due to AEs | 0 | 1 |
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.
| Participants | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Group 2b: LTE Then Late-boost Placebo |
|---|---|---|
| Late-boost (LB) Vaccination Phase: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post Late Boost Vaccination | 37 | 9 |
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.
| Participants | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Group 2b: LTE Then Late-boost Placebo |
|---|---|---|
| Late-boost (LB) Vaccination Phase: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post Late Boost Vaccination | 11 | 4 |
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.
| Participants | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Group 2b: LTE Then Late-boost Placebo |
|---|---|---|
| Late-boost (LB) Vaccination Phase: Number of Participants With Serious Adverse Events (SAEs) | 1 | 1 |
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.
| Participants | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Group 2b: LTE Then Late-boost Placebo |
|---|---|---|
| Late-boost (LB) Vaccination Phase: Number of Participants With AESIs of HIV Infection Up to End of Study | 0 | 2 |
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.
| Participants | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Group 2b: LTE Then Late-boost Placebo |
|---|---|---|
| Late-boost (LB) Vaccination Phase: Number of Participants With AESIs of Thrombosis With Thrombocytopenia Syndrome (TTS) | 0 | 0 |
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.
| ELISA units/milliliter (EU/mL) | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| Clade A (92UG037.1) | 99731.9 (61923.3 to 160625.5) | 88412.7 (7592.1 to 102917.5) | 312.5 (312.5 to 312.5) |
| Clade B (1990a) | 67190.3 (42923 to 105177.6) | 71067.3 (60104.7 to 84029.4) | 94.4 (71.8 to 123.9) |
| Clade C (Con C) | 149924.9 (91195.3 to 246476.1) | 130235.2 (110383.5 to 153656.9) | 333.3 (303.9 to 365.5) |
| Clade C (C97ZA.012) | 65644.1 (43866.4 to 98233.5) | 54942.6 (46038 to 65569.4) | 98.4 (70.7 to 136.9) |
| Mos 1 | 69234.2 (40940.5 to 117081.3) | 73780 (60679.2 to 89709.3) | 39.1 (39.1 to 39.1) |
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.
| ELISA units/milliliter (EU/mL) | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| Clade A (92UG037.1) | 104042.2 (78120.7 to 138564.8) | 139725.1 (117861.4 to 165644.6) | 312.5 (312.5 to 312.5) |
| Clade B (1990a) | 77042.3 (51359.9 to 115567.2) | 133424.3 (111903.8 to 159083.5) | 94.3 (72 to 123.5) |
| Clade C (Con C) | 155117.3 (107852.7 to 223094.6) | 237501.1 (197847.5 to 285102.3) | 323.1 (301.5 to 346.2) |
| Clade C (C97ZA.012) | 92936.2 (60391.6 to 143018.7) | 110083.7 (92455 to 131073.8) | 78.1 (78.1 to 78.1) |
| Mos 1 | 79595 (49206 to 128751.7) | 137520.1 (115722.2 to 163423.8) | 39.1 (39.1 to 39.1) |
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.
| ELISA units/milliliter (EU/mL) | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| Clade A (92UG037.1) | 33049.4 (22287.3 to 49008.4) | 39174.4 (32083 to 47833.2) | 312.5 (312.5 to 312.5) |
| Clade B (1990a) | 20625 (14107.1 to 30154.3) | 33177.5 (27444.9 to 40107.6) | 99.1 (69.7 to 140.8) |
| Clade C (Con C) | 44505.6 (31448.4 to 62984.1) | 57596.5 (47597.1 to 69696.7) | 342 (300.4 to 389.4) |
| Clade C (C97ZA.012) | 18236.1 (11989.7 to 27736.7) | 18857.2 (15759.6 to 22563.7) | 83.1 (73 to 94.6) |
| Mos 1 | 16861.6 (11096.6 to 25621.5) | 25161.6 (20879.1 to 30322.6) | 40.9 (37.2 to 44.9) |
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.
| percentage of responders | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| Clade B (SC42261) | 100 (82.4 to 100) | 100.0 (95.6 to 100.0) | 0 (0 to 0) |
| Clade C (CH505TF) | 100 (82.4 to 100) | 100 (95.6 to 100) | 0 (0 to 0) |
| Clade A (9004S) | 100 (82.4 to 100) | 100 (95.6 to 100) | 0 (0 to 0) |
| Clade B (RHPA) | 100 (82.4 to 100) | 100 (95.6 to 100) | 0 (0 to 0) |
| Clade B (WITO) | 100 (82.4 to 100) | 100 (95.6 to 100) | 0 (0 to 0) |
| Clade C (1086C) | 100 (82.4 to 100) | 100 (95.6 to 100) | 0 (0 to 0) |
| Clade C (BF1266) | 100 (82.4 to 100) | 100 (95.6 to 100) | 0 (0 to 0) |
| CladeAE (conAE) | 100 (82.4 to 100) | 100 (95.6 to 100) | 0 (0 to 0) |
| Clade M(Con S) | 100 (82.4 to 100) | 100 (95.6 to 100) | 0 (0 to 0) |
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.
| percentage of responders | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| Clade B (SC42261) | 100 (78.2 to 100) | 100.0 (95.2 to 100.0) | 0 (0 to 0) |
| Clade C (CH505TF) | 100 (78.2 to 100) | 100 (95.2 to 100) | 0 (0 to 0) |
| Clade A (9004S) | 100 (78.2 to 100) | 100 (95.2 to 100) | 0 (0 to 0) |
| Clade B (RHPA) | 100 (78.2 to 100) | 100 (95.2 to 100) | 0 (0 to 0) |
| Clade B (WITO) | 100 (78.2 to 100) | 100 (95.2 to 100) | 0 (0 to 0) |
| Clade C (1086C) | 100 (78.2 to 100) | 100 (95.2 to 100) | 0 (0 to 0) |
| Clade C (BF1266) | 100 (78.2 to 100) | 100 (95.2 to 100) | 0 (0 to 0) |
| CladeAE (conAE) | 100 (78.2 to 100) | 100 (95.2 to 100) | 0 (0 to 0) |
| Clade M(Con S) | 100 (78.2 to 100) | 100 (95.2 to 100) | 0 (0 to 0) |
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.
| percentage of responders | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| Clade B (SC42261) | 93.8 (69.8 to 99.8) | 94.7 (87.1 to 98.5) | 0 (0 to 0) |
| Clade C (CH505TF) | 100 (78.2 to 100) | 96.1 (89 to 99.2) | 0 (0 to 0) |
| Clade A (9004S) | 100 (78.2 to 100) | 100 (95.2 to 100) | 0 (0 to 0) |
| Clade B (RHPA) | 100 (78.2 to 100) | 100 (95.3 to 100) | 0 (0 to 0) |
| Clade B (WITO) | 100 (78.2 to 100) | 100 (95.3 to 100) | 0 (0 to 0) |
| Clade C (1086C) | 100 (78.2 to 100.0) | 100 (95.3 to 100.0) | 0 (0 to 0) |
| Clade C (BF1266) | 100 (78.2 to 100.0) | 98.7 (93 to 100.0) | 0 (0 to 0) |
| CladeAE (conAE) | 100 (78.2 to 100) | 97.4 (90.9 to 99.7) | 0 (0 to 0) |
| Clade M(Con S) | 100 (78.2 to 100) | 100 (95.3 to 100) | 0 (0 to 0) |
Geometric mean of Env Mos 1 specific binding Abs response at Week 192 were assessed using ELISA.
| ELISA units/milliliter (EU/mL) | Group 1b:LTE Then LB:Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 1 of Main Study) | Group 2b: LTE Then LB: Placebo (Previously in Group 1 of Main Study) | Group 1b:LTE Then LB:Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 2 of Main Study) | 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 | 4044.7 (2132.9 to 7670.2) | 3398.9 (979.0 to 11800.9) | 6816.4 (5125.4 to 9065.2) | 5125.0 (3079.4 to 8529.3) |
Geometric Mean of Env Mos 1 specific binding Abs response at Week 193 were assessed using ELISA.
| ELISA units/milliliter (EU/mL) | Group 1b:LTE Then LB:Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 1 of Main Study) | Group 2b: LTE Then LB: Placebo (Previously in Group 1 of Main Study) | Group 1b:LTE Then LB:Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 2 of Main Study) | 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 | 28412.2 (7194.6 to 112202.7) | 3652.9 (7.7 to 1726909.7) | 46851.6 (26104.6 to 84087.6) | 4505.3 (3439.9 to 5900.6) |
Geometric mean of Env Mos 1 specific binding Abs response at Week 196 were assessed using ELISA.
| ELISA units/milliliter (EU/mL) | Group 1b: LTE Then LB:Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 1 of Main Study) | Group 2b: LTE Then LB: Placebo (Previously in Group 1 of Main Study) | Group 1b: LTE Then LB:Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 2 of Main Study) | 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 | 169017.3 (102848.8 to 277755.8) | 3438.1 (1190.8 to 9926.6) | 174004.6 (124094.4 to 243988.4) | 5153.9 (3377.6 to 7864.4) |
Geometric mean of Env Mos 1 specific binding Abs response at Week 204 were assessed using ELISA.
| ELISA units/milliliter (EU/mL) | Group 1b:LTE Then LB: Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 1 of Main Study) | Group 2b: LTE Then LB: Placebo (Previously in Group 1 of Main Study) | Group 1b:LTE Then LB: Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 2 of Main Study) | 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 | 65259.8 (35974.8 to 118383.9) | 3440.8 (835.5 to 14170.2) | 74715.2 (51288.6 to 108842.1) | 5303.2 (3435.7 to 8185.7) |
Geometric mean of Env Mos 1 specific binding Abs response at Week 216 were assessed using ELISA.
| ELISA units/milliliter (EU/mL) | Group 1b:LTE Then LB: Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 1 of Main Study) | Group 2b: LTE Then LB: Placebo (Previously in Group 1 of Main Study) | Group 1b: LTE Then LB:Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 2 of Main Study) | 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 | 27307.4 (12695.8 to 58735.4) | 3237.3 (4.2 to 2511983.7) | 43831.8 (30033.5 to 63969.3) | 5029.6 (3219.4 to 7857.7) |
Geometric mean of Env Mos 1 specific binding Abs response at Week 240 were assessed using ELISA.
| ELISA units/milliliter (EU/mL) | Group 1b: LTE Then LB:Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 1 of Main Study) | Group 2b: LTE Then LB: Placebo (Previously in Group 1 of Main Study) | Group 1b:LTE Then LB: Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 2 of Main Study) | 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 | 18223.4 (8647.7 to 38402.3) | 3031.1 (19.6 to 467682.9) | 25693.2 (17757.9 to 37174.7) | 4491.1 (2492.1 to 8093.7) |
Geometric mean of Env Mos 1 specific binding Abs response at Week 288 were assessed using ELISA.
| ELISA units/milliliter (EU/mL) | Group 1b: LTE Then LB:Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 1 of Main Study) | Group 2b: LTE Then LB: Placebo (Previously in Group 1 of Main Study) | Group 1b: LTE Then LB:Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 2 of Main Study) | 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 | 18799.1 (8267.1 to 42748.8) | 4742.3 (NA to NA) | 15757.0 (10438.7 to 23784.7) | 3933.1 (2772.2 to 5580.2) |
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.
| Percentage of responders | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| Clade C (MW965): Week 28 | 100.0 (83.2 to 100.0) | 100.0 (96.0 to 100.0) | 0 (0 to 0) |
| Clade C (MW965): Week 52 | 100.0 (80.5 to 100.0) | 100.0 (95.5 to 100.0) | 0 (0 to 0) |
| Clade C (MW965) Week 72 | 100.0 (80.5 to 100.0) | 98.7 (93.1 to 100.0) | — |
| Clade C (97ZA012): Week 28 | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| Clade C (97ZA012): Week 52 | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| Clade C (ZM233M): Week 28 | 0 (0 to 0) | 0 (0 to 0) | — |
| Clade C (ZM233M): Week 52 | 0 (0 to 0) | 0 (0 to 0) | — |
| Clade C (CE703010010): Week 28 | 0 (0 to 0) | 0 (0 to 0) | — |
| Clade C (CE703010010): Week 52 | 0 (0 to 0) | 0 (0 to 0) | — |
| Clade C (2759058): Week 28 | 0 (0 to 0) | 0 (0 to 0) | — |
| Clade C (2759058): Week 52 | 0 (0 to 0) | 0 (0 to 0) | — |
| Clade C (ZM215F): Week 28 | 0 (0 to 0) | 0 (0 to 0) | — |
| Clade C (ZM215F): Week 52 | 0 (0 to 0) | 0 (0 to 0) | — |
| Clade C (SO431): Week 28 | 0 (0 to 0) | 0 (0 to 0) | — |
| Clade C (SO431): Week 52 | 0 (0 to 0) | 0 (0 to 0) | — |
| Clade C (CE704810053): Week 28 | 0 (0 to 0) | 0 (0 to 0) | — |
| Clade C(CE704810053): Week 52 | 0 (0 to 0) | 0 (0 to 0) | — |
Percentage of responders of Env-specific nAbs for tier 1 viruses were planned to be reported.
No measurements were reported for this outcome.
Percentage of responders of Env-specific nAbs for tier 1 viruses were planned to be reported.
No measurements were reported for this outcome.
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.
| Percentage of Responders | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| HIV ENV (gp140 M sortA) A (92UG037) F Ab: Week 28 | 90.0 | 94.4 | 32.0 |
| HIV ENV (gp140 M sortA) B (1990a) F Ab: Week 28 | 90.0 | 98.9 | 0 |
| HIV ENV (gp140 M sortA) C (conC) F Ab: Week 28 | 85.0 | 91.1 | 0 |
| HIV ENV (gp140 T sortA) (Mos1) F Ab: Week 28 | 100.0 | 100.0 | 36.0 |
| HIV ENV (gp140 T sortA) C (ZA) F Ab: Week 28 | 95.0 | 100.0 | 8.0 |
| HIV ENV (gp140 T sortA) C (ZA) F Ab: Week 52 | 100.0 | 100.0 | 13.0 |
| HIV ENV (gp140 T sortA) C (ZA) F Ab: Week 72 | 100.0 | 96.4 | 52.4 |
Percentage of responders for Env-specific functional antibody response (Env ADCP gp140) were planned to be reported.
No measurements were reported for this outcome.
Percentage of responders for Env-specific functional antibody response (Env ADCP gp140) were planned to be reported.
No measurements were reported for this outcome.
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.
| Percentage of Responders | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| HIV ENV (gp140 T) clade C (ZA) IgG-1 Ab: Week 28 | 65.0 (40.8 to 84.6) | 76.7 (66.6 to 84.9) | 0 (0 to 0) |
| HIV ENV (gp140 T) clade C (ZA) IgG-1 Ab: Week 52 | 76.5 (50.1 to 93.2) | 75.6 (64.9 to 84.4) | 0 (0 to 0) |
| HIV ENV (gp140 T) clade C (ZA) IgG-1 Ab: Week 72 | 76.5 (50.1 to 93.2) | 66.3 (55.1 to 76.3) | 0 (0 to 0) |
| HIV ENV (gp140 T) clade C (ZA) IgG-3 Ab: Week 28 | 60.0 (36.1 to 80.9) | 75.0 (64.6 to 83.6) | 8.7 (1.1 to 28.0) |
| HIV ENV (gp140 T) clade C (ZA) IgG-3 Ab: Week 52 | 75.0 (47.6 to 92.7) | 73.2 (62.2 to 82.4) | 0 (0 to 0) |
| HIV ENV (gp140 T) clade C (ZA) IgG-3 Ab: Week 72 | 23.5 (6.8 to 49.9) | 36.6 (26.2 to 48.0) | 14.3 (3.0 to 36.3) |
Percentage of responders for Env-specific binding Ab isotypes IgG1 and IgG3) were planned to be reported.
No measurements were reported for this outcome.
Percentage of responders for Env-specific binding Ab isotypes IgG1 and IgG3) were planned to be reported.
No measurements were reported for this outcome.
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.
| Percentage of Responders | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| HIV IFNg ENV pep pool (Clinical PTE): Week 28 | 90.5 (69.6 to 98.8) | 82.0 (72.5 to 89.4) | 0 (0 to 0) |
| HIV IFNg ENV pep pool (Clinical PTE): Week 52 | 82.4 (56.6 to 96.2) | 87.8 (78.7 to 94.0) | 4.3 (0.1 to 21.9) |
| HIV IFNg ENV pep pool (Clinical PTE): Week 72 | 76.5 (50.1 to 93.2) | 84.3 (74.7 to 91.4) | 4.8 (0.1 to 23.8) |
| HIV IFNg ENV pep pool (Mos1): Week 28 | 90.5 (69.6 to 98.8) | 85.4 (76.3 to 92.0) | 4.0 (0.1 to 20.4) |
| HIV IFNg ENV pep pool (Mos1): Week 52 | 94.1 (71.3 to 99.9) | 84.1 (74.4 to 91.3) | 13.0 (2.8 to 33.6) |
| HIV IFNg ENV pep pool (Mos1): Week 72 | 85.7 (57.2 to 98.2) | 85.9 (76.2 to 92.7) | 10.0 (1.2 to 31.7) |
| HIV IFNg ENV pep pool (Mos2): Week 28 | 81.0 (58.1 to 94.6) | 88.8 (80.3 to 94.5) | 4.0 (0.1 to 20.4) |
| HIV IFNg ENV pep pool (Mos2): Week 52 | 94.1 (71.3 to 99.9) | 87.8 (78.7 to 94.0) | 8.7 (1.1 to 28.0) |
| HIV IFNg ENV pep pool (Mos2): Week 72 | 70.6 (44.0 to 89.7) | 86.7 (77.5 to 93.2) | 4.8 (0.1 to 23.8) |
| HIV IFNg Gag pep pool (Clinical PTE) : Week 28 | 52.4 (29.8 to 74.3) | 31.5 (22.0 to 42.2) | 0 (0 to 0) |
| HIV IFNg Gag pep pool (Clinical PTE) : Week 52 | 41.2 (18.4 to 67.1) | 32.9 (22.9 to 44.2) | 0 (0 to 0) |
| HIV IFNg Gag pep pool (Clinical PTE) : Week 72 | 41.2 (18.4 to 67.1) | 26.5 (17.4 to 37.3) | 0 (0 to 0) |
| HIV IFNg Gag pep pool (Mos1): Week 28 | 52.4 (29.8 to 74.3) | 56.2 (45.3 to 66.7) | 4.0 (0.1 to 20.4) |
| HIV IFNg Gag pep pool (Mos1): Week 52 | 52.9 (27.8 to 77.0) | 51.2 (39.9 to 62.4) | 4.3 (0.1 to 21.9) |
| HIV IFNg Gag pep pool (Mos1): Week 72 | 52.9 (27.8 to 77.0) | 48.2 (37.1 to 59.4) | 4.8 (0.1 to 23.8) |
| HIV IFNg Gag pep pool (Mos2): Week 28 | 61.9 (38.4 to 81.9) | 60.7 (49.7 to 70.9) | 8.0 (1.0 to 26.0) |
| HIV IFNg Gag pep pool (Mos2): Week 52 | 75.0 (47.6 to 92.7) | 52.4 (41.1 to 63.6) | 8.7 (1.1 to 28.0) |
| HIV IFNg Gag pep pool (Mos2): Week 72 | 58.8 (32.9 to 81.6) | 47.0 (35.9 to 58.3) | 0 (0 to 0) |
| HIV IFNg Pol pep pool (Clinical PTE): Week 28 | 76.2 (52.8 to 91.8) | 77.5 (67.4 to 85.7) | 4.0 (0.1 to 20.4) |
| HIV IFNg Pol pep pool (Clinical PTE): Week 52 | 82.4 (56.6 to 96.2) | 86.6 (77.3 to 93.1) | 4.3 (0.1 to 21.9) |
| HIV IFNg Pol pep pool (Clinical PTE): Week 72 | 76.5 (50.1 to 93.2) | 83.1 (73.3 to 90.5) | 0 (0 to 0) |
| HIV IFNg Pol pep pool (Mos1): Week 28 | 76.2 (52.8 to 91.8) | 75.3 (65.0 to 83.8) | 8.0 (1.0 to 26.0) |
| HIV IFNg Pol pep pool (Mos1): Week 52 | 58.8 (32.9 to 81.6) | 78.0 (67.5 to 86.4) | 17.4 (5.0 to 38.8) |
| HIV IFNg Pol pep pool (Mos1): Week 72 | 47.1 (23.0 to 72.2) | 73.5 (62.7 to 82.6) | 0 (0 to 0) |
| HIV IFNg Pol pep pool (Mos2): Week 28 | 76.2 (52.8 to 91.8) | 83.1 (73.7 to 90.2) | 4.0 (0.1 to 20.4) |
| HIV IFNg Pol pep pool (Mos2): Week 52 | 75.0 (47.6 to 92.7) | 85.4 (75.8 to 92.2) | 17.4 (5.0 to 38.8) |
| HIV IFNg Pol pep pool (Mos2): Week 72 | 70.6 (44.0 to 89.7) | 80.7 (70.6 to 88.6) | 9.5 (1.2 to 30.4) |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
| Percentage of responders | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3: Placebo |
|---|---|---|---|
| CD4+: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 28 | 50.00 (27.20 to 72.80) | 80.95 (70.92 to 88.70) | 0 (0 to 0) |
| CD4+: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 52 | 64.29 (35.14 to 87.24) | 77.46 (66.00 to 86.54) | 0 (0 to 0) |
| CD4+: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 72 | 41.18 (18.44 to 67.08) | 69.23 (57.76 to 79.19) | 0 (0 to 0) |
| CD4+: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 50.00 (27.20 to 72.80) | 80.95 (70.92 to 88.70) | 0 (0 to 0) |
| CD4+: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 64.29 (35.14 to 87.24) | 74.65 (62.92 to 84.23) | 0 (0 to 0) |
| CD4+: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 29.41 (10.31 to 55.96) | 69.23 (57.76 to 79.19) | 0 (0 to 0) |
| CD4+: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 40.00 (19.12 to 63.95) | 53.57 (42.35 to 64.53) | 0 (0 to 0) |
| CD4+: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 57.14 (28.86 to 82.34) | 47.89 (35.88 to 60.08) | 0 (0 to 0) |
| CD4+: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 29.41 (10.31 to 55.96) | 21.79 (13.24 to 32.59) | 0 (0 to 0) |
| CD4+: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 28 | 50.00 (27.20 to 72.80) | 82.14 (72.26 to 89.65) | 0 (0 to 0) |
| CD4+: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 52 | 64.29 (35.14 to 87.24) | 77.46 (66.00 to 86.54) | 0 (0 to 0) |
| CD4+: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 72 | 41.18 (18.44 to 67.08) | 69.23 (57.76 to 79.19) | 0 (0 to 0) |
| CD4+: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 28 | 10.00 (1.23 to 31.70) | 8.33 (3.42 to 16.42) | 0 (0 to 0) |
| CD4+: HIV Gag pep pool ANY: Week 52 | 7.14 (0.18 to 33.87) | 9.86 (4.06 to 19.26) | 0 (0 to 0) |
| CD4+: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 72 | 5.88 (0.15 to 28.69) | 1.28 (0.03 to 6.94) | 0 (0 to 0) |
| CD4+: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 10.00 (1.23 to 31.70) | 8.33 (3.42 to 16.42) | 0 (0 to 0) |
| CD4+: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 (0 to 0) | 11.27 (4.99 to 21.00) | 0 (0 to 0) |
| CD4+: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 (0 to 0) | 1.28 (0.03 to 6.94) | 0 (0 to 0) |
| CD4 +: HIV ENV gp120 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 50.00 (27.20 to 72.80) | 80.95 (70.92 to 88.70) | 0 (0 to 0) |
| CD4 +: HIV ENV gp120 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 57.14 (28.86 to 82.34) | 73.24 (61.41 to 83.06) | 0 (0 to 0) |
| CD4 +: HIV ENV gp120 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 29.41 (10.31 to 55.96) | 69.23 (57.76 to 79.19) | 0 (0 to 0) |
| CD4 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 40.00 (19.12 to 63.95) | 47.62 (36.60 to 58.81) | 0 (0 to 0) |
| CD4 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 42.86 (17.66 to 71.14) | 43.66 (31.91 to 55.95) | 0 (0 to 0) |
| CD4 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 23.53 (6.81 to 49.90) | 19.23 (11.18 to 29.73) | 0 (0 to 0) |
| CD4 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 15.79 (3.38 to 39.58) | 28.05 (18.68 to 39.06) | 0 (0 to 0) |
| CD4 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 21.43 (4.66 to 50.80) | 19.72 (11.22 to 30.86) | 0 (0 to 0) |
| CD4 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 5.88 (0.15 to 28.69) | 12.82 (6.32 to 22.32) | 0 (0 to 0) |
| CD4 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 20.00 (5.73 to 43.66) | 32.14 (22.36 to 43.22) | 0 (0 to 0) |
| CD4 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 42.86 (17.66 to 71.14) | 23.94 (14.61 to 35.54) | 0 (0 to 0) |
| CD4 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 5.88 (0.15 to 28.69) | 10.26 (4.53 to 19.21) | 0 (0 to 0) |
| CD4 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 10.00 (1.23 to 31.70) | 8.33 (3.42 to 16.42) | 0 (0 to 0) |
| CD4 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 7.14 (0.18 to 33.87) | 9.86 (4.06 to 19.26) | 0 (0 to 0) |
| CD4 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 5.88 (0.15 to 28.69) | 1.28 (0.03 to 6.94) | 0 (0 to 0) |
| CD4 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 10.00 (1.23 to 31.70) | 2.38 (0.29 to 8.34) | 0 (0 to 0) |
| CD4 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 (0 to 0) | 7.04 (2.33 to 15.67) | 0 (0 to 0) |
| CD4 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 (0 to 0) | 1.28 (0.03 to 6.94) | 0 (0 to 0) |
| CD4 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 10.00 (1.23 to 31.70) | 5.95 (1.96 to 13.35) | 0 (0 to 0) |
| CD4 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 (0 to 0) | 7.04 (2.33 to 15.67) | 0 (0 to 0) |
| CD4 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| CD8 +: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 28 | 21.05 (6.05 to 45.57) | 33.33 (23.58 to 44.25) | 0 (0 to 0) |
| CD8+: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 52 | 29.41 (10.31 to 55.96) | 29.11 (19.43 to 40.42) | 0 (0 to 0) |
| CD8 +: HIV ENV pep pool (Mos1 ZA) IFNg+ or IL2+ (%): Week 72 | 17.65 (3.80 to 43.43) | 26.25 (17.04 to 37.29) | 0 (0 to 0) |
| CD8 +: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 10.53 (1.30 to 33.14) | 29.89 (20.54 to 40.65) | 0 (0 to 0) |
| CD8 +: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 11.76 (1.46 to 36.44) | 26.58 (17.27 to 37.72) | 0 (0 to 0) |
| CD8+: HIV ENV pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 5.88 (0.15 to 28.69) | 25.00 (15.99 to 35.94) | 0 (0 to 0) |
| CD8 +: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 15.79 (3.38 to 39.58) | 14.94 (8.20 to 24.20) | 0 (0 to 0) |
| CD8 +: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 29.41 (10.31 to 55.96) | 13.92 (7.16 to 23.55) | 0 (0 to 0) |
| CD8 +: HIV ENV pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 17.65 (3.80 to 43.43) | 13.75 (7.07 to 23.27) | 0 (0 to 0) |
| CD8 +: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 28 | 73.68 (48.80 to 90.85) | 58.62 (47.55 to 69.08) | 0 (0 to 0) |
| CD8 +: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 52 | 70.59 (44.04 to 89.69) | 58.23 (46.59 to 69.23) | 0 (0 to 0) |
| CD8 +: HIV Env Pol Gag pep pool IFNg+ or IL2+ (%): Week 72 | 52.94 (27.81 to 77.02) | 52.50 (41.02 to 63.79) | 0 (0 to 0) |
| CD8 +: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 28 | 36.84 (16.29 to 61.64) | 21.84 (13.69 to 31.98) | 0 (0 to 0) |
| CD8 +: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 52 | 35.29 (14.21 to 61.67) | 22.78 (14.10 to 33.60) | 0 (0 to 0) |
| CD8 +: HIV Gag pep pool ANY IFNg+ or IL2+ (%): Week 72 | 29.41 (10.31 to 55.96) | 17.50 (9.91 to 27.62) | 0 (0 to 0) |
| CD8 +: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 63.16 (38.36 to 83.71) | 47.13 (36.33 to 58.13) | 0 (0 to 0) |
| CD8 +: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 58.82 (32.92 to 81.56) | 49.37 (37.92 to 60.86) | 0 (0 to 0) |
| CD8 +: HIV Pol pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 29.41 (10.31 to 55.96) | 40.00 (29.20 to 51.56) | 0 (0 to 0) |
| CD8 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 15.79 (3.38 to 39.58) | 9.20 (4.05 to 17.32) | 0 (0 to 0) |
| CD8 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 29.41 (10.31 to 55.96) | 10.13 (4.47 to 18.98) | 0 (0 to 0) |
| CD8 +:HIV ENV gp120 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 17.65 (3.80 to 43.43) | 8.75 (3.59 to 17.20) | 0 (0 to 0) |
| CD8 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 5.56 (0.14 to 27.29) | 11.76 (5.79 to 20.57) | 0 (0 to 0) |
| CD8 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 0 (0 to 0) | 12.66 (6.24 to 22.05) | 0 (0 to 0) |
| CD8 +:HIV ENV gp41 pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 0 (0 to 0) | 13.75 (7.07 to 23.27) | 0 (0 to 0) |
| CD8 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 28 | 0 (0 to 0) | 9.20 (4.05 to 17.32) | 0 (0 to 0) |
| CD8 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 52 | 0 (0 to 0) | 6.33 (2.09 to 14.16) | 0 (0 to 0) |
| CD8 +:HIV ENV gp41 pep pool clade C (ZA) IFNg+ or IL2+ (%): Week 72 | 0 (0 to 0) | 7.50 (2.80 to 15.61) | 0 (0 to 0) |
| CD8 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 36.84 (16.29 to 61.64) | 21.84 (13.69 to 31.98) | 0 (0 to 0) |
| CD8 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 35.29 (14.21 to 61.67) | 22.78 (14.10 to 33.60) | 0 (0 to 0) |
| CD8 +:HIV Gag pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 29.41 (10.31 to 55.96) | 17.50 (9.91 to 27.62) | 0 (0 to 0) |
| CD8 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 28 | 57.89 (33.50 to 79.75) | 29.89 (20.54 to 40.65) | 0 (0 to 0) |
| CD8 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 52 | 47.06 (22.98 to 72.19) | 30.38 (20.53 to 41.75) | 0 (0 to 0) |
| CD8 +:HIV Pol RNAseInt pep pool 1 (Mos1) IFNg+ or IL2+ (%): Week 72 | 17.65 (3.80 to 43.43) | 20.00 (11.89 to 30.44) | 0 (0 to 0) |
| CD8 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 28 | 31.58 (12.58 to 56.55) | 31.03 (21.55 to 41.86) | 0 (0 to 0) |
| CD8 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 52 | 29.41 (10.31 to 55.96) | 30.38 (20.53 to 41.75) | 0 (0 to 0) |
| CD8 +:HIV Pol RT pep pool (Mos1) IFNg+ or IL2+ (%): Week 72 | 23.53 (6.81 to 49.90) | 27.50 (18.10 to 38.62) | 0 (0 to 0) |
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.
No measurements were reported for this outcome.
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.
| Percentage of responders | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Group 2b: LTE Then Late-boost Placebo |
|---|---|---|
| CD4 +:Any Env IFNg+ or IL2+ (%): Week 192 | 82.6 (61.22 to 95.05) | 57.1 (18.41 to 90.10) |
| CD4 +:Any Env IFNg+ or IL2+ (%): Week 196 | 91.3 (71.96 to 98.93) | 83.3 (35.88 to 99.58) |
| CD4 +:Any HIV IFNg+ or IL2+ (%): Week 192 | 82.6 (61.22 to 95.05) | 57.1 (18.41 to 90.10) |
| CD4 +:Any HIV IFNg+ or IL2+ (%): Week 196 | 91.3 (71.96 to 98.93) | 83.3 (35.88 to 99.58) |
| CD4 +:Any MOS1 Env IFNg+ or IL2+ (%): Week 192 | 73.9 (51.59 to 89.77) | 57.1 (18.41 to 90.10) |
| CD4 +:Any MOS1 Env IFNg+ or IL2+ (%): Week 196 | 91.3 (71.96 to 98.93) | 83.3 (35.88 to 99.58) |
| CD4 +:Any MOS2 Env IFNg+ or IL2+ (%): Week 192 | 65.2 (42.73 to 83.62) | 42.9 (9.90 to 81.59) |
| CD4 +:Any MOS2 Env IFNg+ or IL2+ (%): Week 196 | 73.9 (51.59 to 89.77) | 33.3 (4.33 to 77.72) |
| CD4 +:J Mos1 gp120 IFNg+ or IL2+ (%): Week 192 | 73.9 (51.59 to 89.77) | 57.1 (18.41 to 90.10) |
| CD4 +:J Mos1 gp120 IFNg+ or IL2+ (%): Week 196 | 91.3 (71.96 to 98.93) | 83.3 (35.88 to 99.58) |
| CD4 +:J Mos1 gp41 IFNg+ or IL2+ (%): Week 192 | 39.1 (19.71 to 61.46) | 14.3 (0.36 to 57.87) |
| CD4 +:J Mos1 gp41 IFNg+ or IL2+ (%): Week 196 | 43.5 (23.19 to 65.51) | 33.3 (4.33 to 77.72) |
| CD4 +:J Mos2 Gag IFNg+ or IL2+ (%): Week 192 | 21.7 (7.46 to 43.70) | 0 (0 to 0) |
| CD4 +:J Mos2 Gag IFNg+ or IL2+ (%): Week 196 | 39.1 (19.71 to 61.46) | 0 (0 to 0) |
| CD4 +:J Mos2 RNAseInt IFNg+ or IL2+ (%): Week 192 | 17.4 (4.95 to 38.78) | 0 (0 to 0) |
| CD4 +:J Mos2 RNAseInt IFNg+ or IL2+ (%): Week 196 | 17.4 (4.95 to 38.78) | 16.7 (0.42 to 64.12) |
| CD4 +:J Mos2S gp120 IFNg+ or IL2+ (%): Week 192 | 60.9 (38.54 to 80.29) | 42.9 (9.90 to 81.59) |
| CD4 +:J Mos2S gp120 IFNg+ or IL2+ (%): Week 196 | 69.6 (47.08 to 86.79) | 33.3 (4.33 to 77.72) |
| CD4 +:J Mos2S gp41 IFNg+ or IL2+ (%): Week 192 | 21.7 (7.46 to 43.70) | 0 (0 to 0) |
| CD4 +:J Mos2S gp41 IFNg+ or IL2+ (%): Week 196 | 43.5 (23.19 to 65.51) | 16.7 (0.42 to 64.12) |
| CD4 +: POSITIVE CONTROL (CMV) IFNg+ or IL2+ (%): Week 192 | 52.2 (30.59 to 73.18) | 57.1 (18.41 to 90.10) |
| CD4 +: POSITIVE CONTROL (CMV) IFNg+ or IL2+ (%): Week 196 | 50.0 (28.22 to 71.78) | 80.0 (28.36 to 99.49) |
| CD8 +: Any HIV IFNg+ or IL2+ (%): Week 192 | 73.9 (51.59 to 89.77) | 28.6 (3.67 to 70.96) |
| CD8 +: Any HIV IFNg+ or IL2+ (%): Week 196 | 73.9 (51.59 to 89.77) | 33.3 (4.33 to 77.72) |
| CD8 +: Any MOS1 Env IFNg+ or IL2+ (%): Week 192 | 34.8 (16.38 to 57.27) | 14.3 (0.36 to 57.87) |
| CD8 +: Any MOS1 Env IFNg+ or IL2+ (%): Week 196 | 43.5 (23.19 to 65.51) | 16.7 (0.42 to 64.12) |
| CD8 +: Any MOS2 Env IFNg+ or IL2+ (%): Week 192 | 47.8 (26.82 to 69.41) | 14.3 (0.36 to 57.87) |
| CD8 +: Any MOS2 Env IFNg+ or IL2+ (%): Week 196 | 47.8 (26.82 to 69.41) | 33.3 (4.33 to 77.72) |
| CD8 +: J Mos1 gp120 IFNg+ or IL2+ (%): Week 192 | 17.4 (4.95 to 38.78) | 14.3 (0.36 to 57.87) |
| CD8 +: J Mos1 gp120 IFNg+ or IL2+ (%): Week 196 | 26.1 (10.23 to 48.41) | 16.7 (0.42 to 64.12) |
| CD8 +: J Mos1 gp41 IFNg+ or IL2+ (%): Week 192 | 17.4 (4.95 to 38.78) | 0 (0 to 0) |
| CD8 +: J Mos1 gp41 IFNg+ or IL2+ (%): Week 196 | 21.7 (7.46 to 43.70) | 0 (0 to 0) |
| CD8 +: J Mos2 Gag IFNg+ or IL2+ (%): Week 192 | 30.4 (13.21 to 52.92) | 0 (0 to 0) |
| CD8 +: J Mos2 Gag IFNg+ or IL2+ (%): Week 196 | 30.4 (13.21 to 52.92) | 0 (0 to 0) |
| CD8 +: J Mos2 RNAseInt IFNg+ or IL2+ (%): Week 192 | 34.8 (16.38 to 57.27) | 14.3 (0.36 to 57.87) |
| CD8 +: J Mos2 RNAseInt IFNg+ or IL2+ (%): Week 196 | 34.8 (16.38 to 57.27) | 16.7 (0.42 to 64.12) |
| CD8 +: J Mos2S gp120 IFNg+ or IL2+ (%): Week 192 | 30.4 (13.21 to 52.92) | 14.3 (0.36 to 57.87) |
| CD8 +: J Mos2S gp120 IFNg+ or IL2+ (%): Week 196 | 34.8 (16.38 to 57.27) | 16.7 (0.42 to 64.12) |
| CD8 +: J Mos2S gp41 IFNg+ or IL2+ (%): Week 192 | 17.4 (4.95 to 38.78) | 0 (0 to 0) |
| CD8 +: J Mos2S gp41 IFNg+ or IL2+ (%): Week 196 | 17.4 (4.95 to 38.78) | 16.7 (0.42 to 64.12) |
| CD8 +: POSITIVE CONTROL (CMV) IFNg+ or IL2+ (%): Week 192 | 52.2 (30.59 to 73.18) | 71.4 (29.04 to 96.33) |
| CD8 +: POSITIVE CONTROL (CMV) IFNg+ or IL2+ (%): Week 196 | 50.0 (28.22 to 71.78) | 80.0 (28.36 to 99.49) |
Percentage of participants with T-Cell development were planned to be reported.
No measurements were reported for this outcome.
Percentage of participants with T-Cell development were planned to be reported.
No measurements were reported for this outcome.
Percentage of participants with T-Cell Development were planned to be reported.
No measurements were reported for this outcome.
Collected over Group 1 and 2: Baseline up to Week 72 for participants who didn't enter LTE; up Week 216 for participants entering the LTE but not receiving late boost vaccination. Group 3: Baseline up to Week 72. Group 1b and 2b: From Week 188 up to Week 288.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 Main Study and LTE Phase: Ad26.Mos4.HIV + Clade C gp140 | 0/26 (0%) | 1/26 (3.8%) | 25/26 (96.2%) |
| Group 2 Main Study and LTE Phase: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | 0/100 (0%) | 2/100 (2%) | 96/100 (96%) |
| Group 3 Main Study: Placebo | 0/26 (0%) | 0/26 (0%) | 25/26 (96.2%) |
| Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | 0/41 (0%) | 1/41 (2.4%) | 38/41 (92.7%) |
| Group 2b: LTE Then Late-boost Placebo | 0/13 (0%) | 3/13 (23.1%) | 9/13 (69.2%) |
| Event | Group 1 Main Study and LTE Phase: Ad26.Mos4.HIV + Clade C gp140 | Group 2 Main Study and LTE Phase: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3 Main Study: Placebo | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Group 2b: LTE Then Late-boost Placebo |
|---|---|---|---|---|---|
| CholecystitisHepatobiliary disorders | 0/26 | 0/100 | 0/26 | 0/41 | 1/13 |
| Tibia FractureInjury, poisoning and procedural complications | 0/26 | 0/100 | 0/26 | 0/41 | 1/13 |
| Abortion SpontaneousPregnancy, puerperium and perinatal conditions | 1/26 | 0/100 | 0/26 | 0/41 | 1/13 |
| Death NeonatalGeneral disorders | 0/26 | 0/100 | 0/26 | 1/41 | 0/13 |
| Foetal DeathPregnancy, puerperium and perinatal conditions | 0/26 | 0/100 | 0/26 | 1/41 | 0/13 |
| Miscarriage of PartnerSocial circumstances | 0/26 | 1/100 | 0/26 | 1/41 | 0/13 |
| GastritisGastrointestinal disorders | 0/26 | 1/100 | 0/26 | 0/41 | 0/13 |
| GastroenteritisInfections and infestations | 0/26 | 1/100 | 0/26 | 0/41 | 0/13 |
| Event | Group 1 Main Study and LTE Phase: Ad26.Mos4.HIV + Clade C gp140 | Group 2 Main Study and LTE Phase: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3 Main Study: Placebo | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Group 2b: LTE Then Late-boost Placebo |
|---|---|---|---|---|---|
| Pain/Tenderness (Solicited)General disorders | 24/26 | 94/100 | 16/26 | 34/41 | 4/13 |
| Fatigue (Solicited)General disorders | 19/26 | 78/100 | 18/26 | 26/41 | 7/13 |
| Headache (Solicited)Nervous system disorders | 15/26 | 69/100 | 16/26 | 20/41 | 3/13 |
| Myalgia (Solicited)Musculoskeletal and connective tissue disorders | 15/26 | 68/100 | 9/26 | 16/41 | 0/13 |
| Chills (Solicited)General disorders | 12/26 | 48/100 | 1/26 | 5/41 | 3/13 |
| Nausea (Solicited)Gastrointestinal disorders | 9/26 | 46/100 | 9/26 | 3/41 | 1/13 |
| Upper Respiratory Tract InfectionInfections and infestations | 3/26 | 16/100 | 6/26 | 1/41 | 0/13 |
| Aspartate Aminotransferase IncreasedInvestigations | 4/26 | 0/100 | 1/26 | 0/41 | 0/13 |
| Pyrexia (Solicited)General disorders | 2/26 | 15/100 | 1/26 | 1/41 | 0/13 |
| Alanine Aminotransferase IncreasedInvestigations | 3/26 | 1/100 | 1/26 | 0/41 | 0/13 |
The Full Analysis Set (FA) consisted of all participants who were randomized and who received at least one dose of study vaccine.
| Age, Continuous(years) | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3 Main Study: Placebo | Total |
|---|---|---|---|---|
| Mean | 28.7 ± 7.07 | 31.8 ± 8.09 | 30.7 ± 10.11 | 31.1 ± 8.34 |
| Sex: Female, Male(Participants) | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3 Main Study: Placebo | Total |
|---|---|---|---|---|
| Female | 16 | 59 | 15 | 90 |
| Male | 10 | 41 | 11 | 62 |
| Ethnicity (NIH/OMB)(Participants) | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3 Main Study: Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 6 | 4 | 12 |
| Not Hispanic or Latino | 24 | 92 | 22 | 138 |
| Unknown or Not Reported | 0 | 2 | 0 | 2 |
| Race/Ethnicity, Customized(Participants) | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3 Main Study: Placebo | Total |
|---|---|---|---|---|
| Asian | 2 | 7 | 2 | 11 |
| Black or African American | 10 | 38 | 9 | 57 |
| White | 12 | 47 | 12 | 71 |
| Other | 2 | 8 | 3 | 13 |
| Region of Enrollment(Participants) | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Group 3 Main Study: Placebo | Total |
|---|---|---|---|---|
| KENYA | 1 | 4 | 0 | 5 |
| RWANDA | 7 | 26 | 7 | 40 |
| UNITED STATES | 18 | 70 | 19 | 107 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Janssen Vaccines & Prevention B.V.