HIV Vaccine for HIV/AIDS
What You Need to Know Before You Apply
What is the purpose of this trial?
A multicenter, randomized, parallel-group, placebo-controlled, double-blind, Phase 1/2a clinical study to investigate the safety, tolerability, immunogenicity and exploratory efficacy of a vaccine regimen consisting of an Ad26.Mos4.HIV prime and a boost with Modified Vaccinia Ankara (MVA)-BN-HIV in combination with broadly neutralizing antibodies (bNAb) PGT121, PGDM1400, and VRC07-523LS in human immunodeficiency virus type 1 (HIV-1)-infected study participants on suppressive anti-retroviral therapy (ART).
Will I have to stop taking my current medications?
The trial requires participants to be on suppressive anti-retroviral therapy (ART) for at least 48 weeks before screening and to continue it during the study. However, nonsteroidal anti-inflammatory drugs (NSAIDs) and aspirin must be stopped for 5 days before and after planned leukapheresis. Other medications are not specifically mentioned, so it's best to discuss with the study team.
Is the HIV vaccine safe for humans?
The HIV vaccine candidates, including MVA-B and MVA-BN, have been tested in various trials and found to be generally safe in humans, with no serious adverse events reported. Common side effects were mild, such as injection site pain, and the vaccines were well tolerated even in people with HIV.12345
What data supports the effectiveness of the HIV vaccine treatment Ad26.Mos4.HIV, MVA-BN-HIV, PGDM1400, PGT121, VRC07-523LS, VRC07-523LS?
Research on similar treatments, like the MVA-B vaccine, shows it is safe and can trigger strong immune responses, including the production of antibodies and T cells that target HIV. This suggests that the components in the new treatment might also be effective in stimulating the body's defenses against HIV.46789
Who Is on the Research Team?
Boris D Juelg, MD PHD
Principal Investigator
Beth Israel Deaconess Medical Center
Are You a Good Fit for This Trial?
Adults aged 18-70 with HIV, on stable ART for at least 48 weeks, and undetectable viral load. They must understand the study, consent to it, be willing to restart ART if needed, and adhere to protocol restrictions. Excluded are those with acute illness or certain medical conditions like advanced liver disease or history of significant heart issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Vaccination and Follow-up
Participants receive Ad26.Mos4.HIV vaccine at week 0 and MVA-BN-HIV vaccine at week 12, followed by monitoring
bNAb Administration and Washout
Administration of bNAbs PGT121, PGDM1400, and VRC07-523LS, followed by a washout period
Monitoring
Participants are monitored for safety, immunogenicity, and efficacy, including an analytical treatment interruption
What Are the Treatments Tested in This Trial?
Interventions
- Ad26.Mos4.HIV
- MVA-BN-HIV
- PGDM1400
- PGT121
- VRC07-523LS
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boris Juelg, MD PhD
Lead Sponsor
The University of Texas Health Science Center, Houston
Collaborator
Janssen Pharmaceuticals
Industry Sponsor
Joaquin Duato
Janssen Pharmaceuticals
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Pharmaceuticals
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Harvard School of Public Health (HSPH)
Collaborator
Orlando Immunology Center
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator