Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
HIV-related
Enrollment Eligibility
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
Accepts Healthy Volunteers
Call +1 (305) 2439034