Phase 3
N=3,900
A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03964415 ↗Enrolled (actual)
3,900
Serious AEs
4.1%
Results posted
Jul 2024
Primary outcome: 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) — 65; 58 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ad26.Mos4.HIV (Biological); Clade C and Mosaic gp140 HIV bivalent vaccine (Biological); Placebo (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Vaccines & Prevention B.V.
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
65; 58 | — |
| PRIMARY Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 30 Visits (PP Set) |
71; 67 | — |
| SECONDARY Number of Participants With Solicited Local Adverse Events (AEs) |
1225; 329; 905; 239; 1010; 319 | — |
| SECONDARY Number of Participants With Solicited Systemic Adverse Events (AEs) |
1313; 860; 891; 572; 856; 535 | — |
| SECONDARY Number of Participants With Unsolicited Adverse Events (AEs) |
253; 245; 190; 191; 298; 293 | — |
| SECONDARY Number of Participants With Adverse Events of Special Interest (AESIs) |
4; 2 | — |
| SECONDARY Number of Participants With Medically-attended Adverse Events (MAAEs) |
999; 1002 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
82; 77 | — |
| SECONDARY Number of Participants Who Discontinued the Study or Study Intervention Due to Adverse Events (AEs) |
11; 16 | — |
| SECONDARY Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat [mITT] Set) |
124; 123; 130; 132; 130; 133 | — |
| SECONDARY Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-2 [mITT-2] Set) |
75; 71; 81; 80; 81; 81 | — |
| SECONDARY Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-3 [mITT-3] Set) |
75; 71; 81; 80; 81; 81 | — |
| SECONDARY Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Full Immunization Analysis Set [FIS]) |
22; 22; 28; 31; 28; 32 | — |
| SECONDARY Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups |
8; 7; 15; 17; 21; 17 | — |
| SECONDARY Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment |
63; 54; 0; 1; 2; 3 | — |
| SECONDARY Number of Participants With an HIV-1 Infection by Adenovirus Serotype 26 (Ad26) at Baseline |
204; 10 | — |
| SECONDARY Geometric Mean Antibody Titers For Adenovirus Serotype 26 (Ad26) as Determined by Vector Neutralization Assay (VNA) |
66.6; 41.3 | — |
| SECONDARY Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use |
5; 3; 60; 55; 5; 5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03964415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.