HIV Vaccine for HIV/AIDS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new vaccine regimen for people living with HIV who are already on anti-retroviral therapy (ART). Researchers seek to determine the vaccine's safety and effectiveness in boosting the immune system's response to HIV. Participants will receive a combination of vaccines, including Ad26.Mos4.HIV and MVA-BN-HIV, along with antibodies to evaluate their impact on controlling the virus. Ideal candidates are those with HIV who have maintained a stable ART regimen for at least 48 weeks and have a well-controlled viral load. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
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 there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the vaccines Ad26.Mos4.HIV and MVA-BN-HIV are generally safe and well-tolerated. Earlier studies reported that most side effects were mild, with any discomfort or reactions being manageable.
The broadly neutralizing antibodies (bNAbs) PGT121, PGDM1400, and VRC07-523LS have also undergone safety testing. Studies found these antibodies to be safe at various doses, with most participants experiencing no significant side effects.
Overall, both the vaccines and antibodies have demonstrated a good safety record, indicating they are well-tolerated. However, as the study is in its early stages, monitoring for any new safety information remains crucial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for HIV/AIDS because they combine innovative vaccine strategies with powerful broadly neutralizing antibodies (bNAbs). Unlike current antiretroviral therapies that mainly suppress the virus, the Ad26.Mos4.HIV and MVA-BN-HIV vaccines aim to train the immune system to recognize and attack the virus itself. Additionally, the bNAbs—PGT121, PGDM1400, and VRC07-523LS—are designed to target multiple strains of HIV, offering a broader scope of protection. This combination has the potential to not only prevent infection but also provide longer-lasting immunity compared to existing treatments.
What evidence suggests that this trial's treatments could be effective for HIV/AIDS?
Research shows that the Ad26.Mos4.HIV and MVA-BN-HIV vaccines are being tested in this trial to determine their ability to help the body fight HIV. Previous studies of similar vaccines have had mixed results, with one study showing a 31% success rate. These vaccines teach the immune system to recognize and combat HIV.
In this trial, some participants will receive these vaccines along with broadly neutralizing antibodies (bNAbs) like PGT121, PGDM1400, and VRC07-523LS, which have shown promise in lowering HIV levels in the blood. Research has demonstrated that these antibodies can fight various types of HIV and reduce virus levels. Together, these vaccines and antibodies could help the body better control HIV infection. Other participants will receive the vaccines with a placebo, or a placebo with the bNAbs, to compare the effectiveness of these combinations.15678Who 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
Trial Overview
The trial is testing a vaccine regimen (Ad26.Mos4.HIV prime and MVA-BN-HIV boost) combined with antibodies (PGT121, PGDM1400, VRC07-523LS) in HIV-infected adults on ART. It's a Phase 1/2a study assessing safety, tolerability, immune response and preliminary effectiveness.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants will receive Ad26.Mos4.HIV vaccine at week 0 and MVA-BN-HIV vaccine at week 12. The bNAbs PGT121, PGDM1400, and VRC07-523LS will be administered at week 24, and the bNAbs PGT121 and PGDM1400 will be administered at week 28.
Participants will receive Ad26.Mos4.HIV vaccine at week 0 and MVA-BN-HIV vaccine at week 12. Placebo will be administered at week 24, and at week 28.
Participants will receive Placebo at week 0 and 12. The bNAbs PGT121, PGDM1400, and VRC07-523LS will be administered at week 24, and the bNAbs PGT121 and PGDM1400 will be administered at week 28.
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
Citations
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Overall, the HIV DNA and rTV vaccines, whether administered alone or in combination, were safe and well tolerated. Most of AEs were mild and ...
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