Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals.
Detailed description
Human immunodeficiency virus type 1 (HIV-1) is a retrovirus that, if left untreated, can progress to acquired immunodeficiency syndrome (AIDS), a condition in which the immune system is severely compromised, leading to life-threatening conditions. Ad26.Mos4.HIV is a tetravalent vaccine composed of Ad26.Mos1.Gag-Pol, Ad26.Mos2.Gag-Pol, Ad26.Mos1.Env, and Ad26.Mos2S.Env. Clade C and Mosaic gp140 HIV bivalent vaccine contains: Clade C gp140, HIV-1 Env gp140 of Clade C, Mosaic gp140, HIV-1 Env gp140, and aluminum phosphate adjuvant. Evidences showed that a combination of vaccination with Ad26.Mos.HIV followed by Ad26.Mos.HIV together with Clade C gp140 protein in aluminum phosphate adjuvant led to highest level of protection observed so far with this vaccine concept. Study comprises of a screening period of 45 days, a 12-month vaccination period and a follow-up period of at least 18 months after fourth vaccination (until Month 30) in participants who remain HIV-1 negative or up to 6 months after diagnosis of HIV-1 infection in participants who become HIV-1 infected. Participants who completed their Month 30 visit will be followed for HIV infection, medically-attended adverse event (MAAEs) and serious adverse events until the end of study (Month 30). Primary analysis of vaccine efficacy will evaluate the number of HIV-1 infections in the vaccine group compared to number of HIV-1 infections in the placebo group between Month 7 and Month X (with 24\<=X\<=30) in per-protocol population.
Interventions
BIOLOGICALAd26.Mos4.HIV
Participants will receive Ad26.Mos4.HIV via IM injection into the deltoid muscle at months 0 (Day 1), 3, 6 and 12.
BIOLOGICALClade C and Mosaic gp140 HIV bivalent vaccine
Participants will receive Clade C and Mosaic gp140 HIV bivalent vaccine as IM injection into the deltoid muscle at Months 6 and 12.
BIOLOGICALPlacebo
Participants will receive matching placebo.
Sponsors
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Individual is either cis-gender man having sex with cis-gender men and/or transgender individuals or transgender woman having sex with cis-gender men and/or transgender individuals or transgender man having sex with cis-gender men and/or transgender women or gender non-conforming individual having receptive or insertive anal and/or vaginal condom-less intercourse and who is considered by the site staff to be at increased risk for HIV-1 infection. The potential participants must in the last 6 months have had any condom-less receptive anal or vaginal sex (not included is condom-less anal sex within a mutually monogamous relationship \>=12 months if the partner is HIV negative or living with HIV and virally suppressed) or rectal or urethral gonorrhea or chlamydia or incident syphilis or any stimulant use or any other drug and/or substance which in the local context may be associated with increased HIV transmission (example, cocaine, amphetamine) or 5 or more sex partners * Potential participant has a negative test result for HIV-1 and HIV-2 infection less than or equal to (\<=) 28 days prior to first vaccination * Potential participant must be healthy based on medical history, physical examination, and vital sign measurement performed at screening * Contraceptive use by participants assigned female at birth and who have not had sexual reassignment surgery should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies * All participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
Exclusion criteria
* Potential participants choosing to use PrEP. However, once participants are enrolled and received their first vaccination, and they change their mind regarding PrEP usage, they will be allowed to take PrEP according to the site PrEP plan and will continue to receive further vaccinations. The use of long acting PrEP is disallowed from 24 months prior to Day 1 * Potential participant is a recipient of a HIV-vaccine candidate at any time, or a recipient of other experimental vaccine(s) within the last 12 months prior to Day 1. For participants who received an experimental vaccine (except HIV vaccine) more than 12 months prior to Day 1, documentation of the identity of the experimental vaccine must be provided to the HPX3002/HVTN 706 safety review team, who will determine eligibility on a case by-case basis. Exceptions: participants can be included if the vaccine received (except HIV vaccine) was subsequently licensed or authorized for emergency use (example, Emergency Use Authorization (EUA), Emergency Use Listing (EUL), or similar program). Participants with proof of having received only placebo can also be included. Participants who are currently still in an interventional study of such a licensed/emergency use-authorized vaccine are to be excluded from the current study * Potential participant has received an HIV-related mAb, whether licensed or investigational, within the last 12 months prior to Day 1. For participants who received an HIV-related mAb more than 12 months prior to Day 1, documentation of the identity of the mAb must be provided to the HPX3002/HVTN 706 safety review team, who will determine eligibility on a case-by-case basis * Potential participant has known allergy or history of anaphylaxis or other serious adverse reactions to vaccines * Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study vaccination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 24 Visits (Per-protocol [PP] Set) | From Month 7 up to Month 24 | Number of participants with a confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits (PP set) was reported. The data represents the cumulative incidence of HIV-1 infections. |
| Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 30 Visits (PP Set) | From Month 7 up to Month 30 | Number of participants with a confirmed HIV-1 infections diagnosed between the Month 7 and Month 30 visits (PP set) was reported. The data represents the cumulative incidence of HIV-1 infections. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Unsolicited Adverse Events (AEs) | Up to 28 days after each vaccination (dose) on Days 1 (up to Day 29), 84 (up to Day 112), 168 (up to Day 196), and 364 (up to 392) | Number of participants with unsolicited AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participants were not specifically questioned in the participant's diary. |
| Number of Participants With Adverse Events of Special Interest (AESIs) | Up to 6 months after the last vaccination (up to Month 18) | Number of participants with AESIs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Thrombotic events and/or thrombocytopenia (defined as platelet count below the lower limit of normal \[LLN\] range for the testing lab) were considered to be potential AESIs. |
| Number of Participants With Medically-attended Adverse Events (MAAEs) | From Day 1 up to Month 40 | Number of participants with MAAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. |
| Number of Participants With Serious Adverse Events (SAEs) | From Day 1 up to Month 40 | Number of participants with SAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. |
| Number of Participants Who Discontinued the Study or Study Intervention Due to Adverse Events (AEs) | From Day 1 up to Month 40 | Number of participants who discontinued the study or study intervention due to AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
| Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat [mITT] Set) | Month 0 to 24, Month 0 to 30, Month 0 to 40 | Number of participants with a confirmed HIV-1 infections diagnosed over time (mITT set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals. |
| Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-2 [mITT-2] Set) | Month 7 to 24, Month 7 to 30, Month 7 to 40 | Number of participants with a confirmed HIV-1 infections diagnosed over time (mITT-2 set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals. |
| Number of Participants With Solicited Local Adverse Events (AEs) | Up to 7 days post each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371) | Number of participants with solicited local AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site) and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). |
| Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Full Immunization Analysis Set [FIS]) | Month 13 to 24, Month 13 to 30, Month 13 to 40 | Number of participants with confirmed HIV-1 infection diagnosed over time (FIS set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals. |
| Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 24, Month 7 to 30, Month 7 to 40 | Number of participants with confirmed HIV-1 infection as assessed by demographic characteristics: age groups was reported. Age groups included 18-20, 21-24, 25-29, 30-34, 35-44, and greater than or equal to (\>=) 45 years. The data represents the cumulative incidence of HIV-1 infections at specified intervals. |
| Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 24, Month 7 to 30, Month 7 to 40 | Number of participants with confirmed HIV-1 infections as assessed by demographic characteristics: region-wise enrollment was reported. Regions were Latin-America (Argentina, Brazil, Mexico, and Peru), North America (Puerto Rico and United States of America), and Europe (Italy, Poland, and Spain). The data represents the cumulative incidence of HIV-1 infections at specified intervals. |
| Number of Participants With an HIV-1 Infection by Adenovirus Serotype 26 (Ad26) at Baseline | Baseline (Day 1) | Number of participants with an HIV-1 infection by Ad26 at baseline were reported. |
| Geometric Mean Antibody Titers For Adenovirus Serotype 26 (Ad26) as Determined by Vector Neutralization Assay (VNA) | From Day 1 up to Month 40 | Geometric mean antibody titers for Ad26 as determined by VNA were reported. |
| Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use | Month 7 to 24, Month 7 to 30, Month 7 to 40 | Number of participants with HIV-1 infection by P(r)EP use were reported. P(r)EP was assessed with a 4 item survey. Each item was measured on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicating higher levels of self-efficacy. If participant showed any evidence of P(r)EP use during the period based on questionnaire responses, concomitant medications or dried blood spot analysis, the response was yes. The data represents the cumulative incidence of HIV-1 infections at specified intervals. |
| Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-3 [mITT-3] Set) | Month 7 to 24, Month 7 to 30, Month 7 to 40 | Number of participants with confirmed HIV-1 infection diagnosed over time (mITT-3 set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals. |
| Number of Participants With Solicited Systemic Adverse Events (AEs) | Up to 7 days after each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371) | Number of participants with solicited systemic AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). |
Countries
Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 Participants received adenovirus serotype 26.Mosaic 4.human immunodeficiency virus (Ad26.Mos4.HIV) 5\*10\^10 viral particles (vp) intramuscular (IM) injection into the deltoid muscle as a monotherapy at Months 0 (Day 1) and 3 (Day 84) (preferably the deltoid of the non-dominant upper arm) along with adjuvanted protein formulation consisting of Clade C protein 80 micrograms (mcg), Mosaic protein 75 mcg and adjuvanted aluminum phosphate 425 mcg, into the deltoid muscle at Months 6 (Day 168) and 12 (Day 364) (different deltoid for each injection). | 1,942 |
| Group 2: Placebo Participants received placebo into the deltoid muscle at Months 0 (Day 1), 3 (Day 84; 1 injection), 6 (Day 168) and 12 (Day 364; 2 injections). | 1,945 |
| Total | 3,887 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Death | 4 | 6 |
| Overall Study | Lost to Follow-up | 139 | 146 |
| Overall Study | Other | 35 | 38 |
| Overall Study | Physician Decision | 34 | 48 |
| Overall Study | Protocol Violation | 1 | 4 |
| Overall Study | Randomized but not treated | 6 | 7 |
| Overall Study | Sponsor's decision | 1,563 | 1,528 |
| Overall Study | Withdrawal by Subject | 68 | 72 |
Baseline characteristics
| Characteristic | Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Total | Group 2: Placebo |
|---|---|---|---|
| Age, Continuous | 29.7 years STANDARD_DEVIATION 8.28 | 29.8 years STANDARD_DEVIATION 8.43 | 29.9 years STANDARD_DEVIATION 8.58 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1690 Participants | 3365 Participants | 1675 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 238 Participants | 484 Participants | 246 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants | 38 Participants | 24 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 63 Participants | 122 Participants | 59 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 25 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 140 Participants | 301 Participants | 161 Participants |
| Race (NIH/OMB) More than one race | 814 Participants | 1623 Participants | 809 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 10 Participants | 7 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 41 Participants | 76 Participants | 35 Participants |
| Race (NIH/OMB) White | 868 Participants | 1730 Participants | 862 Participants |
| Region of Enrollment Argentina | 202 Participants | 405 Participants | 203 Participants |
| Region of Enrollment Brazil | 425 Participants | 851 Participants | 426 Participants |
| Region of Enrollment Italy | 46 Participants | 90 Participants | 44 Participants |
| Region of Enrollment Mexico | 175 Participants | 347 Participants | 172 Participants |
| Region of Enrollment Peru | 812 Participants | 1620 Participants | 808 Participants |
| Region of Enrollment Poland | 57 Participants | 117 Participants | 60 Participants |
| Region of Enrollment Puerto Rico | 5 Participants | 10 Participants | 5 Participants |
| Region of Enrollment Spain | 128 Participants | 258 Participants | 130 Participants |
| Region of Enrollment United States | 92 Participants | 189 Participants | 97 Participants |
| Sex/Gender, Customized Female (at birth) | 9 Participants | 16 Participants | 7 Participants |
| Sex/Gender, Customized Male (at birth) | 1933 Participants | 3870 Participants | 1937 Participants |
| Sex/Gender, Customized Undifferentiated (at birth) | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 1,942 | 6 / 1,945 |
| other Total, other adverse events | 1,687 / 1,942 | 1,348 / 1,945 |
| serious Total, serious adverse events | 82 / 1,942 | 77 / 1,945 |
Outcome results
Primary
Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 30 Visits (PP Set)
Number of participants with a confirmed HIV-1 infections diagnosed between the Month 7 and Month 30 visits (PP set) was reported. The data represents the cumulative incidence of HIV-1 infections.
Time frame: From Month 7 up to Month 30
Population: The PP set included all participants in the FAS (all randomized participants who received at least one vaccine administration) population who had a negative HIV test 4 weeks post 3rd vaccination visit (that is, at the Month 7 Visit) and who received all planned vaccinations at the first three vaccination visits within the respective visit windows.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 30 Visits (PP Set) | 71 Participants |
| Group 2: Placebo | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 30 Visits (PP Set) | 67 Participants |
Primary
Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 24 Visits (Per-protocol [PP] Set)
Number of participants with a confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits (PP set) was reported. The data represents the cumulative incidence of HIV-1 infections.
Time frame: From Month 7 up to Month 24
Population: The PP set included all participants in the full analysis set (FAS; all randomized participants who received at least one vaccine administration) population who had a negative HIV test 4 weeks post 3rd vaccination visit (that is, at the Month 7 Visit) and who received all planned vaccinations at the first three vaccination visits within the respective visit windows.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 24 Visits (Per-protocol [PP] Set) | 65 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 24 Visits (Per-protocol [PP] Set) | 58 Participants |
Secondary
Geometric Mean Antibody Titers For Adenovirus Serotype 26 (Ad26) as Determined by Vector Neutralization Assay (VNA)
Geometric mean antibody titers for Ad26 as determined by VNA were reported.
Time frame: From Day 1 up to Month 40
Population: The immunogenicity analysis set included participants who acquired HIV-1 (case) and HIV-1 test negative (controls) that were selected for the analysis. Here, 'N' (number of participants analyzed) indicates number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Geometric Mean Antibody Titers For Adenovirus Serotype 26 (Ad26) as Determined by Vector Neutralization Assay (VNA) | 66.6 Titers | 95% Confidence Interval 54.1 |
| Group 2: Placebo | Geometric Mean Antibody Titers For Adenovirus Serotype 26 (Ad26) as Determined by Vector Neutralization Assay (VNA) | 41.3 Titers | 95% Confidence Interval 16.1 |
Secondary
Number of Participants Who Discontinued the Study or Study Intervention Due to Adverse Events (AEs)
Number of participants who discontinued the study or study intervention due to AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: From Day 1 up to Month 40
Population: The FAS set included all randomized participants who received at least one vaccine administration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants Who Discontinued the Study or Study Intervention Due to Adverse Events (AEs) | 11 Participants |
| Group 2: Placebo | Number of Participants Who Discontinued the Study or Study Intervention Due to Adverse Events (AEs) | 16 Participants |
Secondary
Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-2 [mITT-2] Set)
Number of participants with a confirmed HIV-1 infections diagnosed over time (mITT-2 set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals.
Time frame: Month 7 to 24, Month 7 to 30, Month 7 to 40
Population: The mITT-2 efficacy population included participants in the FAS who had a negative HIV test 4 weeks post third vaccination visit (that is, at the Month 7 Visit).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-2 [mITT-2] Set) | Month 7 to 24 | 75 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-2 [mITT-2] Set) | Month 7 to 30 | 81 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-2 [mITT-2] Set) | Month 7 to 40 | 81 Participants |
| Group 2: Placebo | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-2 [mITT-2] Set) | Month 7 to 24 | 71 Participants |
| Group 2: Placebo | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-2 [mITT-2] Set) | Month 7 to 30 | 80 Participants |
| Group 2: Placebo | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-2 [mITT-2] Set) | Month 7 to 40 | 81 Participants |
Secondary
Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat [mITT] Set)
Number of participants with a confirmed HIV-1 infections diagnosed over time (mITT set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals.
Time frame: Month 0 to 24, Month 0 to 30, Month 0 to 40
Population: The mITT efficacy population included participants in the FAS who were HIV-1 uninfected at the date of the first vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat [mITT] Set) | Month 0 to 24 | 124 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat [mITT] Set) | Month 0 to 30 | 130 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat [mITT] Set) | Month 0 to 40 | 130 Participants |
| Group 2: Placebo | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat [mITT] Set) | Month 0 to 24 | 123 Participants |
| Group 2: Placebo | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat [mITT] Set) | Month 0 to 30 | 132 Participants |
| Group 2: Placebo | Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat [mITT] Set) | Month 0 to 40 | 133 Participants |
Secondary
Number of Participants With Adverse Events of Special Interest (AESIs)
Number of participants with AESIs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Thrombotic events and/or thrombocytopenia (defined as platelet count below the lower limit of normal \[LLN\] range for the testing lab) were considered to be potential AESIs.
Time frame: Up to 6 months after the last vaccination (up to Month 18)
Population: The FAS set included all randomized participants who received at least one vaccine administration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Adverse Events of Special Interest (AESIs) | 4 Participants |
| Group 2: Placebo | Number of Participants With Adverse Events of Special Interest (AESIs) | 2 Participants |
Secondary
Number of Participants With an HIV-1 Infection by Adenovirus Serotype 26 (Ad26) at Baseline
Number of participants with an HIV-1 infection by Ad26 at baseline were reported.
Time frame: Baseline (Day 1)
Population: The immunogenicity analysis set included participants who acquired HIV-1 (case) and HIV-1 test negative (controls) that were selected for the case-control analysis. Here, 'N' (number of participants analyzed) indicates number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With an HIV-1 Infection by Adenovirus Serotype 26 (Ad26) at Baseline | 204 Participants |
| Group 2: Placebo | Number of Participants With an HIV-1 Infection by Adenovirus Serotype 26 (Ad26) at Baseline | 10 Participants |
Secondary
Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups
Number of participants with confirmed HIV-1 infection as assessed by demographic characteristics: age groups was reported. Age groups included 18-20, 21-24, 25-29, 30-34, 35-44, and greater than or equal to (\>=) 45 years. The data represents the cumulative incidence of HIV-1 infections at specified intervals.
Time frame: Month 7 to 24, Month 7 to 30, Month 7 to 40
Population: The PP set included all participants in the FAS (who received at least one vaccine administration) population who had a negative HIV test 4 weeks post third vaccination visit (that is, at Month 7 Visit) and who received all planned vaccinations at the first 3 vaccination visits within the respective visit windows. Here, 'n' (number analyzed) indicated participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 24 (Age Group: 18-20 years) | 8 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 24 (Age Group: 21-24 years) | 15 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 24 (Age Group: 25-29 years) | 21 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 24 (Age Group: 30-34 years) | 7 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 24 (Age Group: 35-44 years) | 12 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 24 (Age Group: >=45 years) | 2 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 30 (Age Group: 18-20 years) | 9 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 30 (Age Group: 21-24 years) | 18 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 30 (Age Group: 25-29 years) | 22 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 30 (Age Group: 30-34 years) | 8 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 30 (Age Group: 35-44 years) | 12 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 30 (Age Group: >=45 years) | 2 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 40 (Age Group: 18-20 years) | 9 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 40 (Age Group: 21-24 years) | 18 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 40 (Age Group: 25-29 years) | 22 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 40 (Age Group: 30-34 years) | 8 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 40 (Age Group: 35-44 years) | 12 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 40 (Age Group: >=45 years) | 2 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 40 (Age Group: 21-24 years) | 17 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 24 (Age Group: 18-20 years) | 7 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 30 (Age Group: 30-34 years) | 8 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 24 (Age Group: 21-24 years) | 17 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 40 (Age Group: >=45 years) | 4 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 24 (Age Group: 25-29 years) | 17 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 30 (Age Group: 35-44 years) | 7 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 24 (Age Group: 30-34 years) | 7 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 40 (Age Group: 25-29 years) | 22 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 24 (Age Group: 35-44 years) | 6 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 30 (Age Group: >=45 years) | 4 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 24 (Age Group: >=45 years) | 4 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 40 (Age Group: 35-44 years) | 7 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 30 (Age Group: 18-20 years) | 10 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 40 (Age Group: 18-20 years) | 10 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 30 (Age Group: 21-24 years) | 17 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 40 (Age Group: 30-34 years) | 8 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups | Month 7 to 30 (Age Group: 25-29 years) | 21 Participants |
Secondary
Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment
Number of participants with confirmed HIV-1 infections as assessed by demographic characteristics: region-wise enrollment was reported. Regions were Latin-America (Argentina, Brazil, Mexico, and Peru), North America (Puerto Rico and United States of America), and Europe (Italy, Poland, and Spain). The data represents the cumulative incidence of HIV-1 infections at specified intervals.
Time frame: Month 7 to 24, Month 7 to 30, Month 7 to 40
Population: The PP set included all participants in the FAS (who received at least one vaccine administration) population who had a negative HIV test 4 weeks post third vaccination visit (that is, at Month 7 Visit) and who received all planned vaccinations at the first 3 vaccination visits within the respective visit windows. Here, 'n' (number analyzed) indicated participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 24: North America | 0 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 30: Europe | 3 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 30: Latin America | 68 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 40: Latin America | 68 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 24: Europe | 2 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 40: North America | 0 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 30: North America | 0 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 40: Europe | 3 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 24: Latin America | 63 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 40: Europe | 3 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 24: Latin America | 54 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 24: North America | 1 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 24: Europe | 3 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 30: Latin America | 63 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 30: North America | 1 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 30: Europe | 3 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 40: Latin America | 64 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment | Month 7 to 40: North America | 1 Participants |
Secondary
Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Full Immunization Analysis Set [FIS])
Number of participants with confirmed HIV-1 infection diagnosed over time (FIS set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals.
Time frame: Month 13 to 24, Month 13 to 30, Month 13 to 40
Population: The FIS included participants in the FAS who were HIV-1 uninfected 4 weeks after the fourth vaccination visit (that is, at Month 13 Visit) and who received all planned vaccinations within the respective visit windows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Full Immunization Analysis Set [FIS]) | Month 13 to 24 | 22 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Full Immunization Analysis Set [FIS]) | Month 13 to 30 | 28 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Full Immunization Analysis Set [FIS]) | Month 13 to 40 | 28 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Full Immunization Analysis Set [FIS]) | Month 13 to 24 | 22 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Full Immunization Analysis Set [FIS]) | Month 13 to 30 | 31 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Full Immunization Analysis Set [FIS]) | Month 13 to 40 | 32 Participants |
Secondary
Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-3 [mITT-3] Set)
Number of participants with confirmed HIV-1 infection diagnosed over time (mITT-3 set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals.
Time frame: Month 7 to 24, Month 7 to 30, Month 7 to 40
Population: The mITT-3 efficacy population included participants in the FAS who had a negative HIV test 4 weeks post third vaccination visit (that is, at the Month 7 Visit) and who received all planned vaccinations at the first three vaccination visits regardless of the fact if the vaccinations were within the visit windows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-3 [mITT-3] Set) | Month 7 to 24 | 75 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-3 [mITT-3] Set) | Month 7 to 30 | 81 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-3 [mITT-3] Set) | Month 7 to 40 | 81 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-3 [mITT-3] Set) | Month 7 to 24 | 71 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-3 [mITT-3] Set) | Month 7 to 30 | 80 Participants |
| Group 2: Placebo | Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-3 [mITT-3] Set) | Month 7 to 40 | 81 Participants |
Secondary
Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use
Number of participants with HIV-1 infection by P(r)EP use were reported. P(r)EP was assessed with a 4 item survey. Each item was measured on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicating higher levels of self-efficacy. If participant showed any evidence of P(r)EP use during the period based on questionnaire responses, concomitant medications or dried blood spot analysis, the response was yes. The data represents the cumulative incidence of HIV-1 infections at specified intervals.
Time frame: Month 7 to 24, Month 7 to 30, Month 7 to 40
Population: The PP set included all subjects in FAS (all randomized participants who received at least one vaccine) set who had a negative HIV test 4 weeks post 3rd vaccination visit (that is, at Month 7 Visit) and who received all planned vaccinations at the first three vaccination visits within respective visit windows. Here, 'N' (number of participants analyzed) is number of participants evaluable for this outcome measure and 'n' (number analyzed) indicated participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use | Month 7 to 24: P(r)EP Use=Y | 5 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use | Month 7 to 24: P(r)EP Use=N | 60 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use | Month 7 to 30: P(r)EP Use=Y | 5 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use | Month 7 to 30: P(r)EP Use=N | 66 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use | Month 7 to 40: P(r)EP Use=Y | 5 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use | Month 7 to 40: P(r)EP Use=N | 66 Participants |
| Group 2: Placebo | Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use | Month 7 to 40: P(r)EP Use=Y | 5 Participants |
| Group 2: Placebo | Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use | Month 7 to 24: P(r)EP Use=Y | 3 Participants |
| Group 2: Placebo | Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use | Month 7 to 30: P(r)EP Use=N | 62 Participants |
| Group 2: Placebo | Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use | Month 7 to 24: P(r)EP Use=N | 55 Participants |
| Group 2: Placebo | Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use | Month 7 to 40: P(r)EP Use=N | 63 Participants |
| Group 2: Placebo | Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use | Month 7 to 30: P(r)EP Use=Y | 5 Participants |
Secondary
Number of Participants With Medically-attended Adverse Events (MAAEs)
Number of participants with MAAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.
Time frame: From Day 1 up to Month 40
Population: The FAS set included all randomized participants who received at least one vaccine administration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Medically-attended Adverse Events (MAAEs) | 999 Participants |
| Group 2: Placebo | Number of Participants With Medically-attended Adverse Events (MAAEs) | 1002 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs)
Number of participants with SAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Time frame: From Day 1 up to Month 40
Population: The FAS set included all randomized participants who received at least one vaccine administration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Serious Adverse Events (SAEs) | 82 Participants |
| Group 2: Placebo | Number of Participants With Serious Adverse Events (SAEs) | 77 Participants |
Secondary
Number of Participants With Solicited Local Adverse Events (AEs)
Number of participants with solicited local AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site) and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Time frame: Up to 7 days post each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371)
Population: The FAS set included all randomized participants who received at least one vaccine administration. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Solicited Local Adverse Events (AEs) | Up to 7 days post dose on Day 1 | 1225 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Solicited Local Adverse Events (AEs) | Up to 7 days post dose on Day 84 | 905 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Solicited Local Adverse Events (AEs) | Up to 7 days post dose on Day 168 | 1010 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Solicited Local Adverse Events (AEs) | Up to 7 days post dose on Day 364 | 917 Participants |
| Group 2: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) | Up to 7 days post dose on Day 364 | 252 Participants |
| Group 2: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) | Up to 7 days post dose on Day 1 | 329 Participants |
| Group 2: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) | Up to 7 days post dose on Day 168 | 319 Participants |
| Group 2: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) | Up to 7 days post dose on Day 84 | 239 Participants |
Secondary
Number of Participants With Solicited Systemic Adverse Events (AEs)
Number of participants with solicited systemic AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Time frame: Up to 7 days after each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371)
Population: The FAS set included all randomized participants who received at least one vaccine administration. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Solicited Systemic Adverse Events (AEs) | Up to 7 days post dose on Day 1 | 1313 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Solicited Systemic Adverse Events (AEs) | Up to 7 days post dose on Day 84 | 891 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Solicited Systemic Adverse Events (AEs) | Up to 7 days post dose on Day 168 | 856 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Solicited Systemic Adverse Events (AEs) | Up to 7 days post dose on Day 371 | 759 Participants |
| Group 2: Placebo | Number of Participants With Solicited Systemic Adverse Events (AEs) | Up to 7 days post dose on Day 371 | 432 Participants |
| Group 2: Placebo | Number of Participants With Solicited Systemic Adverse Events (AEs) | Up to 7 days post dose on Day 1 | 860 Participants |
| Group 2: Placebo | Number of Participants With Solicited Systemic Adverse Events (AEs) | Up to 7 days post dose on Day 168 | 535 Participants |
| Group 2: Placebo | Number of Participants With Solicited Systemic Adverse Events (AEs) | Up to 7 days post dose on Day 84 | 572 Participants |
Secondary
Number of Participants With Unsolicited Adverse Events (AEs)
Number of participants with unsolicited AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participants were not specifically questioned in the participant's diary.
Time frame: Up to 28 days after each vaccination (dose) on Days 1 (up to Day 29), 84 (up to Day 112), 168 (up to Day 196), and 364 (up to 392)
Population: The FAS set included all randomized participants who received at least one vaccine administration. Here, 'n' (number analyzed) is defined as participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Unsolicited Adverse Events (AEs) | Up to 28 days post dose on Day 1 | 253 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Unsolicited Adverse Events (AEs) | Up to 28 days post dose on Day 84 | 190 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Unsolicited Adverse Events (AEs) | Up to 28 days post dose on Day 168 | 298 Participants |
| Group 1: Ad26.Mos4.HIV + Clade C and Mosaic gp140 | Number of Participants With Unsolicited Adverse Events (AEs) | Up to 28 days post dose on Day 364 | 249 Participants |
| Group 2: Placebo | Number of Participants With Unsolicited Adverse Events (AEs) | Up to 28 days post dose on Day 364 | 297 Participants |
| Group 2: Placebo | Number of Participants With Unsolicited Adverse Events (AEs) | Up to 28 days post dose on Day 1 | 245 Participants |
| Group 2: Placebo | Number of Participants With Unsolicited Adverse Events (AEs) | Up to 28 days post dose on Day 168 | 293 Participants |
| Group 2: Placebo | Number of Participants With Unsolicited Adverse Events (AEs) | Up to 28 days post dose on Day 84 | 191 Participants |