| 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. | Full analysis set (FAS) included all participants who were randomized and who received at least one dose of study vaccine. | Posted | | Count of Participants | | Participants | | Up to 7 days post-vaccination 1 on Day 1 (up to Day 8) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | Group 3: 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). |
| | | Title | Denominators | Categories |
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| Solicited local AE | | | | Solicited systemic AE | |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | FAS included all participants who were randomized and who received at least one dose of study vaccine. | Posted | | Count of Participants | | Participants | | Up to 28 days post-vaccination 1 on Day 1 (Up to Day 29) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | FAS included all participants who were randomized and who received at least one dose of study vaccine. | Posted | | Count of Participants | | Participants | | From Baseline (Day 1) up to Week 72 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | |
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| 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. | FAS included all participants who were randomized and who received at least one dose of study vaccine. | Posted | | Count of Participants | | Participants | | From Baseline (Day 1) up to Week 72 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | From Baseline (Day 1) up to Week 216 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit). | Posted | | Count of Participants | | Participants | | From Week 188 up to end of study (Week 288) | | | | ID | Title | Description |
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| OG000 | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. | | OG001 | Group 2b: LTE Then Late-boost Placebo | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with placebo matching to Ad26.Mos4.HIV and matching to gp140 HIV bivalent as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. |
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| 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. | LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit). | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. |
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| 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. | LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit). | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. | | OG001 | Group 2b: LTE Then Late-boost Placebo |
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| 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. | LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit). | Posted | | Count of Participants | | Participants | | From Week 188 up to end of study (Week 288) | | | | ID | Title | Description |
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| OG000 | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. | | OG001 |
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| 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. | LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit). | Posted | | Count of Participants | | Participants | | From Week 188 up to end of study (Week 288) | | | | ID | Title | Description |
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| OG000 | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. | |
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| 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. | LB included all participants who received LB vaccination (at least one of the 2 vaccines at LB visit). | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | ELISA units/milliliter (EU/mL) | | Week 28 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | ELISA units/milliliter (EU/mL) | | Week 52 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | ELISA units/milliliter (EU/mL) | | Week 72 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of responders | | Week 28 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of responders | | Week 52 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of responders | | Week 72 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | ELISA units/milliliter (EU/mL) | | Week 192 | | | | ID | Title | Description |
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| OG000 | Group 1b:LTE Then LB:Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 1 of Main Study) | Participants from Group 1 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. | | OG001 | Group 2b: LTE Then LB: Placebo (Previously in Group 1 of Main Study) | Participants from Group 1 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with placebo matching to Ad26.Mos4.HIV and matching to gp140 HIV bivalent as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | ELISA units/milliliter (EU/mL) | | Week 193 | | | | ID | Title | Description |
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| OG000 | Group 1b:LTE Then LB:Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 1 of Main Study) | Participants from Group 1 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. | | OG001 | Group 2b: LTE Then LB: Placebo (Previously in Group 1 of Main Study) | Participants from Group 1 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with placebo matching to Ad26.Mos4.HIV and matching to gp140 HIV bivalent as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | ELISA units/milliliter (EU/mL) | | Week 196 | | | | ID | Title | Description |
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| OG000 | Group 1b: LTE Then LB:Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 1 of Main Study) | Participants from Group 1 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. | | OG001 | Group 2b: LTE Then LB: Placebo (Previously in Group 1 of Main Study) | Participants from Group 1 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with placebo matching to Ad26.Mos4.HIV and matching to gp140 HIV bivalent as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | ELISA units/milliliter (EU/mL) | | Week 204 | | | | ID | Title | Description |
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| OG000 | Group 1b:LTE Then LB: Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 1 of Main Study) | Participants from Group 1 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. | | OG001 | Group 2b: LTE Then LB: Placebo (Previously in Group 1 of Main Study) | Participants from Group 1 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with placebo matching to Ad26.Mos4.HIV and matching to gp140 HIV bivalent as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | ELISA units/milliliter (EU/mL) | | Week 216 | | | | ID | Title | Description |
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| OG000 | Group 1b:LTE Then LB: Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 1 of Main Study) | Participants from Group 1 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. | | OG001 | Group 2b: LTE Then LB: Placebo (Previously in Group 1 of Main Study) | Participants from Group 1 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with placebo matching to Ad26.Mos4.HIV and matching to gp140 HIV bivalent as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | ELISA units/milliliter (EU/mL) | | Week 240 | | | | ID | Title | Description |
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| OG000 | Group 1b: LTE Then LB:Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 1 of Main Study) | Participants from Group 1 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. | | OG001 | Group 2b: LTE Then LB: Placebo (Previously in Group 1 of Main Study) | Participants from Group 1 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with placebo matching to Ad26.Mos4.HIV and matching to gp140 HIV bivalent as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | ELISA units/milliliter (EU/mL) | | Week 288 | | | | ID | Title | Description |
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| OG000 | Group 1b: LTE Then LB:Ad26.Mos4.HIV+gp140 HIV Bivalent Vaccine (Previously in Group 1 of Main Study) | Participants from Group 1 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. | | OG001 | Group 2b: LTE Then LB: Placebo (Previously in Group 1 of Main Study) | Participants from Group 1 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with placebo matching to Ad26.Mos4.HIV and matching to gp140 HIV bivalent as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of responders | | Weeks 28, 52, and 72 (only for Clade C [MW965]) | | | | ID | Title | Description |
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| OG000 | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Participants received single intramuscular (IM) injection of Ad26.Mos4.HIV vaccine 5*10^10 viral particles (vp) at Weeks 0 and 12, 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 and 48. 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 extension. | | OG001 |
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| 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. | 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. | Posted | | | | | | From Week 72 to Week 216 | | | | ID | Title | Description |
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| OG000 | Group 1: Ad26.Mos4.HIV + Clade C gp140 | Participants received single intramuscular (IM) injection of Ad26.Mos4.HIV vaccine 5*10^10 viral particles (vp) at Weeks 0 and 12, 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 and 48. 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 extension. | | OG001 | 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. |
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| 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. | 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. | Posted | | | | | | From Week 188 up to end of study (Week 288) | | | | ID | Title | Description |
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| OG000 | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. | | OG001 | Group 2b: LTE Then Late-boost Placebo | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with placebo matching to Ad26.Mos4.HIV and matching to gp140 HIV bivalent as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. |
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| 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. | 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. | Posted | | Number | | Percentage of Responders | | Weeks 28, 52, and 72 (Weeks 52 and 72 are only for HIV ENV [gp140 T sortA] C [ZA] F Ab) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | | | | | From Week 72 up to Week 216 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 |
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| 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. | 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. | Posted | | | | | | From Week 188 up to end of study (Week 288) | | | | ID | Title | Description |
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| OG000 | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. | | OG001 | Group 2b: LTE Then Late-boost Placebo | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with placebo matching to Ad26.Mos4.HIV and matching to gp140 HIV bivalent as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of Responders | | Weeks 28, 52, and 72 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | | | | | From Week 72 up to Week 216 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 |
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| 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. | 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. | Posted | | | | | | From Week 188 up to end of study (Week 288) | | | | ID | Title | Description |
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| OG000 | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. | | OG001 | Group 2b: LTE Then Late-boost Placebo | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with placebo matching to Ad26.Mos4.HIV and matching to gp140 HIV bivalent as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of Responders | | Weeks 28, 52, and 72 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | | | | | From Week 72 up to Week 216 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | | | | | From Week 188 up to end of study (Week 288) | | | | ID | Title | Description |
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| OG000 | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. | | OG001 | Group 2b: LTE Then Late-boost Placebo | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with placebo matching to Ad26.Mos4.HIV and matching to gp140 HIV bivalent as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of responders | | Weeks 28, 52, and 72 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | | | | | From Week 72 up to Week 216 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of responders | | Weeks 192 and 196 | | | | ID | Title | Description |
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| OG000 | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. | | OG001 | Group 2b: LTE Then Late-boost Placebo |
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| Secondary | Main Study: Percentage of Participants With T-Cell Development | Percentage of participants with T-Cell development were planned to be reported. | 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. | Posted | | | | | | From Baseline (Day 1) up to Week 72 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 |
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| 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. | 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. | Posted | | | | | | From Week 72 up to Week 216 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | |
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| 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. | 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. | Posted | | | | | | From Week 188 up to end of study (Week 288) | | | | ID | Title | Description |
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| OG000 | Group 1b: LTE Then Late-boost Ad26.Mos4.HIV + gp140 HIV Bivalent Vaccine | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with Ad26.Mos4.HIV and bivalent gp140 containing adjuvanted protein co-formulation with 80 mcg Clade C protein, 75 mcg Mosaic protein and 425 mcg aluminum (as aluminum phosphate adjuvant) as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. | | OG001 | Group 2b: LTE Then Late-boost Placebo | Participants from Group 1 and 2 of main study that entered the LTE phase were offered to enter in extension of LTE phase (late boost vaccination phase) and received late- boost vaccination with placebo matching to Ad26.Mos4.HIV and matching to gp140 HIV bivalent as IM injection within 4 weeks prior to Week 192 until 4 months after Week 192 (that is, any day from Week 188 to Week 208) and were followed up until Week 288. |
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