Trial Outcomes & Findings for Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad26.Mos4.HIV Along With Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults (NCT NCT02788045)

Last Updated: 2025-05-25

Results Overview

Solicited local AEs were predefined local events (at the injection site: erythema, induration, swelling, itching and warmth) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

201 participants

Primary outcome timeframe

7 days after first vaccination on Day 1 (Day 8)

Results posted on

2025-05-25

Participant Flow

A total of 201 participants were enrolled, out of which 198 participants were randomized and vaccinated; 3 participants were not vaccinated and hence were not included in analyses.

Participant milestones

Participant milestones
Measure	Tetravalent Ad26.Mos4.HIV Vaccine Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Main Study (Up to Week 72) STARTED	110	55	33
Main Study (Up to Week 72) COMPLETED	94	45	28
Main Study (Up to Week 72) NOT COMPLETED	16	10	5
Long Term Extension (From Wk 72 to 264) STARTED	77	0	0
Long Term Extension (From Wk 72 to 264) COMPLETED	60	0	0
Long Term Extension (From Wk 72 to 264) NOT COMPLETED	17	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Tetravalent Ad26.Mos4.HIV Vaccine Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Main Study (Up to Week 72) Adverse Event	0	1	1
Main Study (Up to Week 72) Lost to Follow-up	5	4	3
Main Study (Up to Week 72) Pregnancy	1	1	0
Main Study (Up to Week 72) Protocol Violation	1	0	0
Main Study (Up to Week 72) Withdrawal by Subject	6	4	1
Main Study (Up to Week 72) Other	3	0	0
Long Term Extension (From Wk 72 to 264) Lost to Follow-up	8	0	0
Long Term Extension (From Wk 72 to 264) Withdrawal by Subject	8	0	0
Long Term Extension (From Wk 72 to 264) Other	1	0	0

Baseline Characteristics

Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad26.Mos4.HIV Along With Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=110 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=55 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=33 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.	Total n=198 Participants Total of all reporting groups
Age, Continuous	28.0 years n=5 Participants	27.0 years n=7 Participants	27.0 years n=5 Participants	27.0 years n=4 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	32 Participants n=7 Participants	24 Participants n=5 Participants	110 Participants n=4 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	23 Participants n=7 Participants	9 Participants n=5 Participants	88 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	23 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	96 Participants n=5 Participants	48 Participants n=7 Participants	29 Participants n=5 Participants	173 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	35 Participants n=5 Participants	18 Participants n=7 Participants	7 Participants n=5 Participants	60 Participants n=4 Participants
Race/Ethnicity, Customized White	58 Participants n=5 Participants	24 Participants n=7 Participants	23 Participants n=5 Participants	105 Participants n=4 Participants
Race/Ethnicity, Customized More than one race	6 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	13 Participants n=4 Participants
Race/Ethnicity, Customized Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Region of Enrollment RWANDA	10 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	17 Participants n=4 Participants
Region of Enrollment UNITED STATES	100 Participants n=5 Participants	50 Participants n=7 Participants	31 Participants n=5 Participants	181 Participants n=4 Participants

PRIMARY outcome

Timeframe: 7 days after first vaccination on Day 1 (Day 8)

Population: The full analysis set (FAS) included all participants who were randomized and who received at least one dose of study vaccine.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=110 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=55 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=33 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Participants With Solicited Local Adverse Events (AEs) Post First Vaccination	70.9 percentage of participants	78.2 percentage of participants	27.3 percentage of participants

PRIMARY outcome

Timeframe: 7 days after second vaccination on Day 85 (Day 92)

Population: The FAS included all participants who were randomized and who received at least one dose of study vaccine. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=102 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=51 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=32 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Participants With Solicited Local AEs Post Second Vaccination	83.3 percentage of participants	76.5 percentage of participants	50 percentage of participants

PRIMARY outcome

Timeframe: 7 days after third vaccination on Day 169 (Day 176)

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=99 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=49 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=32 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Participants With Solicited Local AEs Post Third Vaccination	80.8 percentage of participants	79.6 percentage of participants	21.9 percentage of participants

PRIMARY outcome

Timeframe: 7 days after fourth vaccination on Day 337 (Day 344)

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=94 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=45 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=27 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Participants With Solicited Local AEs Post Fourth Vaccination	84 percentage of participants	68.9 percentage of participants	29.6 percentage of participants

PRIMARY outcome

Timeframe: 7 days after first vaccination on Day 1 (Day 8)

Population: FAS included all participants who were randomized and who received at least one dose of study vaccine.

An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Solicited systemic AEs including pyrexia/fever, headache, fatigue, myalgia, nausea and chills were collected within 7 days after vaccination.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=110 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=55 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=33 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Participants With Solicited Systemic AEs Post First Vaccination	69.1 percentage of participants	83.6 percentage of participants	54.5 percentage of participants

PRIMARY outcome

Timeframe: 7 days after second vaccination on Day 85 (Day 92)

Population: FAS included all participants who were randomized and who received at least one dose of study vaccine. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Solicited systemic AEs including pyrexia/fever, headache, fatigue, myalgia, nausea and chills were collected within 7 days after vaccination.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=102 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=51 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=32 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Participants With Solicited Systemic AEs Post Second Vaccination	66.7 percentage of participants	54.9 percentage of participants	40.6 percentage of participants

PRIMARY outcome

Timeframe: 7 days after third vaccination on Day 169 (Day 176)

An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Solicited systemic AEs including pyrexia/fever, headache, fatigue, myalgia, nausea and chills were collected within 7 days after vaccination.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=99 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=49 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=32 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Participants With Solicited Systemic AEs Post Third Vaccination	59.6 percentage of participants	44.9 percentage of participants	34.4 percentage of participants

PRIMARY outcome

Timeframe: 7 days after fourth vaccination on Day 337 (Day 344)

An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Solicited systemic AEs including pyrexia/fever, headache, fatigue, myalgia, nausea and chills were collected within 7 days after vaccination.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=94 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=45 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=27 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Participants With Solicited Systemic AEs Post Fourth Vaccination	58.5 percentage of participants	53.3 percentage of participants	33.3 percentage of participants

PRIMARY outcome

Timeframe: 28 days after first vaccination on Day 1 (Day 29)

Population: The FAS included all participants who were randomized and who received at least one dose of study vaccine.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=110 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=55 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=33 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Participants With Unsolicited AEs for 28 Days After First Vaccination	38.2 percentage of participants	41.8 percentage of participants	30.3 percentage of participants

PRIMARY outcome

Timeframe: 28 days after second vaccination on Day 85 (Day 113)

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=102 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=51 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=32 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Participants With Unsolicited AEs for 28 Days After Second Vaccination	30.4 percentage of participants	23.5 percentage of participants	37.5 percentage of participants

PRIMARY outcome

Timeframe: 28 days after third vaccination on Day 169 (Day 197)

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=99 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=49 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=32 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Participants With Unsolicited AEs for 28 Days After Third Vaccination	28.3 percentage of participants	20.4 percentage of participants	21.9 percentage of participants

PRIMARY outcome

Timeframe: 28 days after fourth vaccination on Day 334 (Day 362)

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=94 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=45 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=27 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Participants With Unsolicited AEs for 28 Days After Fourth Vaccination	36.2 percentage of participants	22.2 percentage of participants	40.7 percentage of participants

PRIMARY outcome

Timeframe: Up to Week 72

Population: The FAS included all participants who were randomized and who received at least one dose of study vaccine.

Percentage of participants with discontinuations from vaccination due to AEs were reported.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=110 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=55 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=33 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Participants With Discontinuations From Vaccination Due to AEs	0 percentage of participants	1.8 percentage of participants	6.1 percentage of participants

PRIMARY outcome

Timeframe: Up to Week 72

Population: The FAS included all participants who were randomized and who received at least one dose of study vaccine.

An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. SAE was defined as any AE that resulted in: death, persistent or significant disability/incapacity, required inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, was a congenital anomaly/birth defect and would jeopardize participant and/or required medical or surgical intervention to prevent one of the outcomes listed above.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=110 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=55 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=33 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Participants With Serious Adverse Events (SAEs) During Main Study	5.5 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: From Week 96 to Week 264

Population: The FAS included all participants those were all the participants from the Tetravalent Ad26.Mos4.HIV group who had received all 4 vaccinations and were negative for HIV infections at Week 72.

An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. SAE was defined as any AE that resulted in: death, persistent or significant disability/incapacity, required inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, was a congenital anomaly/birth defect and would jeopardize participant and/or required medical or surgical intervention to prevent one of the outcomes listed above. This outcome measure was planned to be analyzed for specified arm only.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=77 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Participants With SAEs During Long Term Extension (LTE) Period	5.2 percentage of participants	—	—

PRIMARY outcome

Timeframe: Up to Week 72

Population: The FAS included all participants who were randomized and who received at least one dose of study vaccine.

Percentage of participants with AEs of special interest during main study were reported. HIV infection was considered as an AE of special interest.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=110 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=55 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=33 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Participants With AEs of Special Interest During Main Study	0 percentage of participants	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: From Week 96 to Week 264

Percentage of participants with AEs of special interest during LTE period were reported. HIV infection was considered as an AE of special interest. This outcome measure was planned to be analyzed for specified arm only.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=77 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Participants With AEs of Special Interest During LTE Period	0 percentage of participants	—	—

PRIMARY outcome

Timeframe: Week 28

Population: The PPI analysis set included all participants who had received at least first three vaccinations, according to protocol-specified vaccination schedule (+/- 2 weeks), had at least 1 measured post-dose blood sample collected and were not diagnosed with HIV infection during the study. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants evaluable for specified categories.

Percentage of responders for envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) specific binding antibody titers at Week 28 were reported. Env Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012)-specific binding antibody titers were assessed using enzyme-linked immunosorbent assay (ELISA). 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.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=98 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=48 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=31 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 Clade B (1990a)	100 percentage of responders Interval 96.3 to 100.0	100 percentage of responders Interval 92.6 to 100.0	12.9 percentage of responders Interval 3.6 to 29.8
Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 Clade C (Con C)	100 percentage of responders Interval 96.2 to 100.0	100 percentage of responders Interval 92.6 to 100.0	12.9 percentage of responders Interval 3.6 to 29.8
Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 Clade C (C97ZA.012)	100 percentage of responders Interval 96.3 to 100.0	100 percentage of responders Interval 92.6 to 100.0	6.5 percentage of responders Interval 0.8 to 21.4
Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 Clade A (92UG037.1)	100 percentage of responders Interval 96.3 to 100.0	100 percentage of responders Interval 92.6 to 100.0	19.4 percentage of responders Interval 7.5 to 37.5

PRIMARY outcome

Timeframe: Week 52

Percentage of responders for envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) specific binding antibody titers at Week 52 were reported. Env Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012)-specific binding antibody titers were assessed using enzyme-linked immunosorbent assay (ELISA). 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.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=98 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=48 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=31 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 Clade A (92UG037.1)	100 percentage of responders Interval 96.1 to 100.0	100 percentage of responders Interval 91.2 to 100.0	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 Clade C (Con C)	100 percentage of responders Interval 96.1 to 100.0	100 percentage of responders Interval 91.2 to 100.0	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 Clade C (C97ZA.012)	100 percentage of responders Interval 96.1 to 100.0	100 percentage of responders Interval 91.2 to 100.0	3.7 percentage of responders Interval 0.1 to 19.0
Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 Clade B (1990a)	100 percentage of responders Interval 96.1 to 100.0	100 percentage of responders Interval 91.2 to 100.0	22.2 percentage of responders Interval 8.6 to 42.3

PRIMARY outcome

Timeframe: Week 72

Percentage of responders for envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) specific binding antibody titers at Week 72 were reported. Env Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012)-specific binding antibody titers were assessed using enzyme-linked immunosorbent assay (ELISA). 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.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=98 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=48 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=31 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 Clade A (92UG037.1)	100 percentage of responders Interval 96.1 to 100.0	100 percentage of responders Interval 91.8 to 100.0	2 percentage of responders Interval 0.9 to 24.3
Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 Clade C (Con C)	100 percentage of responders Interval 96.0 to 100.0	100 percentage of responders Interval 91.8 to 100.0	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 Clade C (C97ZA.012)	100 percentage of responders Interval 96.1 to 100.0	100 percentage of responders Interval 91.8 to 100.0	3.7 percentage of responders Interval 0.1 to 19.0
Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 Clade B (1990a)	100 percentage of responders Interval 96.1 to 100.0	100 percentage of responders Interval 91.8 to 100.0	11.1 percentage of responders Interval 2.4 to 29.2

SECONDARY outcome

Timeframe: Weeks 28, 52 and 72

The functionality of vaccine-induced antibody responses was investigated by the determination of nAb activity in a virus neutralization assay (VNA) using TZM-bl cells and Env-pseudotyped viruses. The response was defined as post-baseline value \>LLOQ. The LLOQ for this assay was an inhibitory concentration (IC50) of 20 (fold-dilution). The data was collected for the responses against Tier 1 HIV strain Clade C (MW965.26 and C97ZA.012).

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=98 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=48 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=30 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) Clade C (MW965.26) Week 52	100 percentage of responders Interval 96.1 to 100.0	90 percentage of responders Interval 76.3 to 97.2	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) Clade C (MW965.26) Week 72	98.9 percentage of responders Interval 94.1 to 100.0	100 percentage of responders Interval 85.8 to 100.0	—
Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) Clade C (MW965.26) Week 28	99 percentage of responders Interval 94.4 to 100.0	66.7 percentage of responders Interval 51.6 to 79.6	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) Clade C (C97ZA.012) Week 28	0 percentage of responders Interval 0.0 to 0.0	0 percentage of responders Interval 0.0 to 0.0	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) Clade C (C97ZA.012) Week 52	0 percentage of responders Interval 0.0 to 0.0	0 percentage of responders Interval 0.0 to 0.0	0 percentage of responders Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Weeks 28, 52 and 72

The functionality of vaccine-induced antibody responses was investigated by the determination of ADCP. 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 (C97ZA.012), and Mos1, respectively.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=98 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=47 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=31 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody Clade C (Con C) at Week 28	88.8 percentage of responders Interval 80.8 to 94.3	66 percentage of responders Interval 50.7 to 79.1	16.1 percentage of responders Interval 5.5 to 33.7
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody Clade A (92UG037.1) at Week 28	72.4 percentage of responders Interval 62.5 to 81.0	36.2 percentage of responders Interval 22.7 to 51.5	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody Clade B (1990a) at Week 28	69.4 percentage of responders Interval 59.3 to 78.3	57.4 percentage of responders Interval 42.2 to 71.7	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody Mos1 at Week 28	100 percentage of responders Interval 96.3 to 100.0	100 percentage of responders Interval 92.5 to 100.0	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody Clade C (C97ZA.012) at Week 28	98 percentage of responders Interval 92.8 to 99.8	93.6 percentage of responders Interval 82.5 to 98.7	3.2 percentage of responders Interval 0.1 to 16.7
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody Clade C (C97ZA.012) at Week 52	97.8 percentage of responders Interval 92.4 to 99.7	82.5 percentage of responders Interval 67.2 to 92.7	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody Clade C (C97ZA.012) at Week 72	98.9 percentage of responders Interval 94.1 to 100.0	97.7 percentage of responders Interval 87.7 to 99.9	18.5 percentage of responders Interval 6.3 to 38.1

SECONDARY outcome

Timeframe: Weeks 26, 52 and 72

Frozen peripheral blood mononuclear cell (PBMCs) were analyzed by interferon-gamma (IFN-gamma) (ELISpot). 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.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=99 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=48 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=31 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Pol peptide pool PTE at Week 72	87.6 percentage of responders Interval 79.0 to 93.7	90 percentage of responders Interval 76.3 to 97.2	11.1 percentage of responders Interval 2.4 to 29.2
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Pol peptide pool Mos1 at Week 26	88.9 percentage of responders Interval 81.0 to 94.3	85.4 percentage of responders Interval 72.2 to 93.9	3.2 percentage of responders Interval 0.1 to 16.7
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Pol peptide pool Mos1 at Week 52	82.6 percentage of responders Interval 73.3 to 89.7	92.5 percentage of responders Interval 79.6 to 98.4	3.8 percentage of responders Interval 0.1 to 19.6
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Pol peptide pool Mos2 at Week 72	89.9 percentage of responders Interval 81.7 to 95.3	92.5 percentage of responders Interval 79.6 to 98.4	7.4 percentage of responders Interval 0.9 to 24.3
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) ENV peptide pool potential T-cell epitope (PTE) at Week 26	96 percentage of responders Interval 90.0 to 98.9	79.2 percentage of responders Interval 65.0 to 89.5	3.2 percentage of responders Interval 0.1 to 16.7
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) ENV peptide pool PTE at Week 52	95.7 percentage of responders Interval 89.2 to 98.8	85 percentage of responders Interval 70.2 to 94.3	3.8 percentage of responders Interval 0.1 to 19.6
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) ENV peptide pool PTE at Week 72	97.8 percentage of responders Interval 92.1 to 99.7	83.3 percentage of responders Interval 68.6 to 93.0	3.7 percentage of responders Interval 0.1 to 19.0
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) ENV peptide pool Mos1 at Week 26	96 percentage of responders Interval 90.0 to 98.9	87.5 percentage of responders Interval 74.8 to 95.3	6.5 percentage of responders Interval 0.8 to 21.4
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) ENV peptide pool Mos1 at Week 52	98.9 percentage of responders Interval 94.1 to 100.0	92.5 percentage of responders Interval 79.6 to 98.4	3.8 percentage of responders Interval 0.1 to 19.6
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) ENV peptide pool Mos1 at Week 72	97.8 percentage of responders Interval 92.1 to 99.7	92.9 percentage of responders Interval 80.5 to 98.5	18.5 percentage of responders Interval 6.3 to 38.1
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) ENV peptide pool Mos2 at Week 26	96 percentage of responders Interval 90.0 to 98.9	58.3 percentage of responders Interval 43.2 to 72.4	3.2 percentage of responders Interval 0.1 to 16.7
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) ENV peptide pool Mos2 at Week 52	93.5 percentage of responders Interval 86.3 to 97.6	77.5 percentage of responders Interval 61.5 to 89.2	3.8 percentage of responders Interval 0.1 to 19.6
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) ENV peptide pool Mos2 at Week 72	95.5 percentage of responders Interval 88.9 to 98.8	70 percentage of responders Interval 53.5 to 83.4	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Gag peptide pool PTE at Week 26	58.6 percentage of responders Interval 48.2 to 68.4	60.4 percentage of responders Interval 45.3 to 74.2	3.2 percentage of responders Interval 0.1 to 16.7
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Gag peptide pool PTE at Week 52	57.6 percentage of responders Interval 46.9 to 67.9	70 percentage of responders Interval 53.5 to 83.4	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Gag peptide pool PTE at Week 72	41.6 percentage of responders Interval 31.2 to 52.5	47.6 percentage of responders Interval 32.0 to 63.6	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Gag peptide pool Mos1 at Week 26	59.6 percentage of responders Interval 49.3 to 69.3	54.2 percentage of responders Interval 39.2 to 68.6	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Gag peptide pool Mos1 at Week 52	60.9 percentage of responders Interval 50.1 to 70.9	60 percentage of responders Interval 43.3 to 75.1	3.8 percentage of responders Interval 0.1 to 19.6
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Gag peptide pool Mos1 at Week 72	57.3 percentage of responders Interval 46.4 to 67.7	54.8 percentage of responders Interval 38.7 to 70.2	3.7 percentage of responders Interval 0.1 to 19.0
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Gag peptide pool Mos2 at Week 26	69.7 percentage of responders Interval 59.6 to 78.5	60.4 percentage of responders Interval 45.3 to 74.2	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Gag peptide pool Mos2 at Week 52	65.2 percentage of responders Interval 54.6 to 74.9	62.5 percentage of responders Interval 45.8 to 77.3	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Gag peptide pool Mos2 at Week 72	64 percentage of responders Interval 53.2 to 73.9	60 percentage of responders Interval 43.3 to 75.1	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Pol peptide pool PTE at Week 26	87.9 percentage of responders Interval 79.8 to 93.6	91.7 percentage of responders Interval 80.0 to 97.7	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Pol peptide pool PTE at Week 52	84.8 percentage of responders Interval 75.8 to 91.4	85 percentage of responders Interval 70.2 to 94.3	3.8 percentage of responders Interval 0.1 to 19.6
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Pol peptide pool Mos1 at Week 72	85.4 percentage of responders Interval 76.3 to 92.0	81 percentage of responders Interval 65.9 to 91.4	14.8 percentage of responders Interval 4.2 to 33.7
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Pol peptide pool Mos2 at Week 26	92.9 percentage of responders Interval 86.0 to 97.1	93.8 percentage of responders Interval 82.8 to 98.7	3.2 percentage of responders Interval 0.1 to 16.7
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) Pol peptide pool Mos2 at Week 52	89.1 percentage of responders Interval 80.9 to 94.7	90 percentage of responders Interval 76.3 to 97.2	3.8 percentage of responders Interval 0.1 to 19.6

SECONDARY outcome

Timeframe: Weeks 28, 52 and 72

Vaccine-induced binding antibody IgG1 and IgG3 subclass responses were investigated using Clade C (C97ZA.012) specific ELISAs. 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 for IgG1 and IgG3, respectively.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=93 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=44 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=29 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Clade C (C97ZA.012) IgG1 at Week 28	72.8 percentage of responders Interval 62.6 to 81.6	61.4 percentage of responders Interval 45.5 to 75.6	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Clade C (C97ZA.012) IgG1 at Week 72	67.0 percentage of responders Interval 56.4 to 76.5	50 percentage of responders Interval 34.2 to 65.8	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Clade C (C97ZA.012) IgG3 at Week 72	37.1 percentage of responders Interval 27.1 to 48.0	31 percentage of responders Interval 17.6 to 47.1	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Clade C (C97ZA.012) IgG1 at Week 52	73.1 percentage of responders Interval 62.9 to 81.8	67.5 percentage of responders Interval 50.9 to 81.4	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Clade C (C97ZA.012) IgG3 at Week 28	67.4 percentage of responders Interval 56.8 to 76.8	18.2 percentage of responders Interval 8.2 to 32.7	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Clade C (C97ZA.012) IgG3 at Week 52	66.3 percentage of responders Interval 55.7 to 75.8	46.2 percentage of responders Interval 30.1 to 62.8	0 percentage of responders Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Weeks 28, 52 and 72

Population: The PPI analysis set included all participants who had received at least first three vaccinations, according to protocol-specified vaccination schedule (+/- 2 weeks), had at least 1 measured post-dose blood sample collected and were not diagnosed with HIV during the study. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants evaluable at specified categories

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.

Outcome measures

Outcome measures
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=97 Participants Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=48 Participants Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=31 Participants Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV pep pool (PP) (Mos1) IFNg+ /IL2+ Wk 28	53.61 percentage of responders Interval 43.19 to 63.8	41.67 percentage of responders Interval 27.61 to 56.79	3.23 percentage of responders Interval 0.08 to 16.7
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 52	75.82 percentage of responders Interval 65.72 to 84.19	55 percentage of responders Interval 38.49 to 70.74	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 52	63.74 percentage of responders Interval 52.99 to 73.56	35.00 percentage of responders Interval 20.63 to 51.68	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 72	51.28 percentage of responders Interval 39.69 to 62.77	10.53 percentage of responders Interval 2.94 to 24.8	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV pol gag PP IFNg+ /IL2+ Wk 28	57.73 percentage of responders Interval 47.28 to 67.7	45.83 percentage of responders Interval 31.37 to 60.83	3.23 percentage of responders Interval 0.08 to 16.7
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV Pol PP (Mos1) IFNg+ /IL2+ Wk 72	6.41 percentage of responders Interval 2.11 to 14.33	5.26 percentage of responders Interval 0.64 to 17.75	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD8+ ENV PP (Mos1) IFNg+ /IL2+ Wk 28	35.42 percentage of responders Interval 25.92 to 45.84	43.75 percentage of responders Interval 29.48 to 58.82	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD8+ ENV PP (Mos1) IFNg+ /IL2+ Wk 52	30.77 percentage of responders Interval 21.51 to 41.32	42.50 percentage of responders Interval 27.04 to 59.11	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD8+ ENV PP (Mos1) IFNg+ /IL2+ Wk 72	29.11 percentage of responders Interval 19.43 to 40.42	26.32 percentage of responders Interval 13.4 to 43.1	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD8+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 28	41.67 percentage of responders Interval 31.68 to 52.18	45.83 percentage of responders Interval 31.37 to 60.83	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD8+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 52	34.07 percentage of responders Interval 24.45 to 44.75	45.00 percentage of responders Interval 29.26 to 61.51	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD8+ ENV Pol gag PP IFNg+ /IL2+ Wk 28	76.04 percentage of responders Interval 66.25 to 84.17	81.25 percentage of responders Interval 67.37 to 91.05	3.23 percentage of responders Interval 0.08 to 16.7
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD8+ Pol PP (Mos1) IFNg+ /IL2+ Wk 52	54.95 percentage of responders Interval 44.16 to 65.4	50.00 percentage of responders Interval 33.8 to 66.2	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD8+ Pol PP (Mos1) IFNg+ /IL2+ Wk 72	51.90 percentage of responders Interval 40.36 to 63.29	36.84 percentage of responders Interval 21.81 to 54.01	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV PP (Mos1) IFNg+ /IL2+ Wk 52	64.84 percentage of responders Interval 54.12 to 74.56	50.00 percentage of responders Interval 33.8 to 66.2	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV PP (Mos1) IFNg+ /IL2+ Wk 72	53.85 percentage of responders Interval 42.18 to 65.21	36.84 percentage of responders Interval 21.81 to 54.01	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 28	56.70 percentage of responders Interval 46.25 to 66.73	43.75 percentage of responders Interval 29.48 to 58.82	3.23 percentage of responders Interval 0.08 to 16.7
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 72	64.10 percentage of responders Interval 52.44 to 74.66	36.84 percentage of responders Interval 21.81 to 54.01	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 28	46.39 percentage of responders Interval 36.2 to 56.81	18.75 percentage of responders Interval 8.95 to 32.63	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV pol gag PP IFNg+ /IL2+ Wk 52	75.82 percentage of responders Interval 65.72 to 84.19	55 percentage of responders Interval 38.49 to 70.74	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV pol gag PP IFNg+ /IL2+ Wk 72	64.10 percentage of responders Interval 52.44 to 74.66	36.84 percentage of responders Interval 21.81 to 54.01	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV gag PP ANY IFNg+ /IL2+ Wk 28	8.25 percentage of responders Interval 3.63 to 15.61	6.25 percentage of responders Interval 1.31 to 17.2	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV gag PP ANY IFNg+ /IL2+ Wk 52	3.30 percentage of responders Interval 0.69 to 9.33	10.00 percentage of responders Interval 2.79 to 23.66	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV gag PP ANY IFNg+ /IL2+ Wk 72	2.56 percentage of responders Interval 0.31 to 8.96	5.26 percentage of responders Interval 0.64 to 17.75	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV Pol PP (Mos1) IFNg+ /IL2+ Wk 28	8.25 percentage of responders Interval 3.63 to 15.61	8.33 percentage of responders Interval 2.32 to 19.98	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD4+ ENV Pol PP (Mos1) IFNg+ /IL2+ Wk 52	6.59 percentage of responders Interval 2.46 to 13.8	7.50 percentage of responders Interval 1.57 to 20.39	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD8+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 72	34.18 percentage of responders Interval 23.87 to 45.71	28.95 percentage of responders Interval 15.42 to 45.9	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD8+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 28	21.88 percentage of responders Interval 14.08 to 31.47	22.92 percentage of responders Interval 12.03 to 37.31	0 percentage of responders Interval 0.0 to 0.0
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD8+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 52	15.38 percentage of responders Interval 8.67 to 24.46	17.50 percentage of responders Interval 7.34 to 32.78	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD8+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 72	16.46 percentage of responders Interval 9.06 to 26.49	10.53 percentage of responders Interval 2.94 to 24.8	—
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD8+ ENV Pol gag PP IFNg+ /IL2+ Wk 52	71.43 percentage of responders Interval 61.0 to 80.41	77.50 percentage of responders Interval 61.55 to 89.16	3.70 percentage of responders Interval 0.09 to 18.97
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD8+ ENV Pol gag PP IFNg+ /IL2+ Wk 72	69.62 percentage of responders Interval 58.25 to 79.47	65.79 percentage of responders Interval 48.65 to 80.37	4.00 percentage of responders Interval 0.1 to 20.35
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD8+ ENV gag PP ANY IFNg+ /IL2+ Wk 28	39.58 percentage of responders Interval 29.75 to 50.08	39.58 percentage of responders Interval 25.77 to 54.73	3.23 percentage of responders Interval 0.08 to 16.7
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD8+ ENV gag PP ANY IFNg+ /IL2+ Wk 52	32.91 percentage of responders Interval 22.75 to 44.4	31.58 percentage of responders Interval 17.5 to 48.65	4.00 percentage of responders Interval 0.1 to 20.35
Percentage of Responders for CD4+ and CD8+ T-Cell Responses CD8+ Pol PP (Mos1) IFNg+ /IL2+ Wk 28	62.50 percentage of responders Interval 52.03 to 72.18	62.50 percentage of responders Interval 47.35 to 76.05	—

SECONDARY outcome

Timeframe: Up to Week 264

As per change in planned analysis, this outcome measure was not performed since it was no longer considered relevant to interpret the immunogenicity of the vaccines.

Outcome measures

Outcome data not reported

Adverse Events

Tetravalent Ad26.Mos4.HIV Vaccine

Serious events: 9 serious events

Other events: 37 other events

Deaths: 0 deaths

Trivalent Ad26.Mos.HIV Vaccine

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=110 participants at risk Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=55 participants at risk Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=33 participants at risk Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Cardiac disorders Angina Pectoris	0.91% 1/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Cardiac disorders Atrial Fibrillation	0.91% 1/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Infections and infestations Covid-19 Pneumonia	0.91% 1/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Infections and infestations Pneumonia	0.91% 1/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Injury, poisoning and procedural complications Ankle Fracture	0.91% 1/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	0.91% 1/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acoustic Neuroma	0.91% 1/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Nervous system disorders Syncope	0.91% 1/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.91% 1/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Psychiatric disorders Bipolar I Disorder	0.91% 1/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Vascular disorders Lymphoedema	0.91% 1/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section

Other adverse events

Other adverse events
Measure	Tetravalent Ad26.Mos4.HIV Vaccine n=110 participants at risk Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264).	Trivalent Ad26.Mos.HIV Vaccine n=55 participants at risk Participants received Ad26.Mos4.HIV vaccine 5\10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72.	Placebo n=33 participants at risk Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72.
Infections and infestations Gastroenteritis	4.5% 5/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	5.5% 3/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	3.0% 1/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Infections and infestations Upper Respiratory Tract Infection	15.5% 17/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	16.4% 9/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	30.3% 10/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Infections and infestations Urinary Tract Infection	1.8% 2/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	7.3% 4/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Infections and infestations Viral Infection	6.4% 7/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	3.6% 2/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Injury, poisoning and procedural complications Muscle Strain	0.00% 0/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	6.1% 2/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Investigations Alanine Aminotransferase Increased	4.5% 5/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	3.6% 2/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	9.1% 3/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Investigations Haemoglobin Decreased	0.00% 0/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	5.5% 3/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Renal and urinary disorders Proteinuria	2.7% 3/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	5.5% 3/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	0.00% 0/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	1.8% 2/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	5.5% 3/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	3.0% 1/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section
Skin and subcutaneous tissue disorders Dermatitis Contact	0.91% 1/110 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	1.8% 1/55 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section	6.1% 2/33 • Up to Week 264 The full analysis set (FAS) included of all participants who were randomized and who received atleast one dose of study vaccine. One participant had serious adverse event during main study and long-term extension period. This participant has only been counted once in the adverse event section

Additional Information

Clinical Franchise Leader

Janssen Vaccines & Prevention B.V

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER