A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 EFFICACY STUDY OF AHETEROLOGOUS VACCINE REGIMEN OF AD26.MOS4.HIV AND ADJUVANTED CLADE C GP140 ANDMOSAIC GP140 TO PREVENT HIV-1 INFECTION AMONG CIS-GENDER MEN AND TRANSGENDERINDIVIDUALS WHO HAVE SEX WITH CIS-GENDER MEN AND/OR TRANSGENDER INDIVIDUALS.
- Conditions
- -B24 Unspecified human immunodeficiency virus [HIV] diseaseUnspecified human immunodeficiency virus [HIV] diseaseB24
- Registration Number
- PER-035-19
- Lead Sponsor
- Janssen Vaccines & Prevention B.V.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1620
- 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 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 (example, cocaine, amphetamine) or 5 or more sex partners.
- Potential participant is negative for HIV-1 and HIV-2 infection less than (<) 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 highly sensitive urine or 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.
- Potential participants choosing to use PrEP. However, once participants received the first vaccination, they will be allowed to start PrEP while in the study according to the site PrEP
plan. 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method