HIV Trimer mRNA Vaccines for HIV Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new mRNA-based vaccines designed to prevent HIV. Researchers aim to determine if these vaccines are safe and can effectively trigger the immune system to combat HIV. Different groups will receive various forms and doses of the vaccine to compare results. Individuals not infected with HIV and considered low-risk for acquiring it, such as those on stable pre-exposure prophylaxis (PrEP), might be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive medications, you must not have taken them within 168 days before the first vaccination. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the BG505 MD39.3 mRNA vaccines are generally safe and well-tolerated. In earlier studies, recipients developed immune responses, indicating that the body reacted to the vaccine as intended. However, some side effects have been reported. Specifically, one study found that many participants experienced chronic urticaria, meaning they had itchy skin rashes that persisted after vaccination.
This research remains in the early stages, with the primary focus on studying safety. The information gathered will help researchers understand how people react to the vaccine. For those considering joining a trial, this data helps set expectations about potential outcomes. Always consult a healthcare professional before deciding to participate in a clinical trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these HIV Trimer mRNA vaccines because they represent a novel approach to HIV prevention. Unlike traditional vaccines, which often rely on weakened or inactivated viruses, these vaccines use mRNA technology to instruct cells to produce proteins that mimic parts of the HIV virus, specifically targeting the BG505 MD39.3 protein structure. This method aims to trigger a stronger and more targeted immune response. The use of mRNA technology also allows for faster production and scalability, potentially speeding up the availability of effective vaccines. This approach could pave the way for more efficient and adaptable vaccines against HIV.
What evidence suggests that this trial's HIV trimer mRNA vaccines could be effective for HIV prevention?
Research shows that mRNA technology holds promise for creating an HIV vaccine. Previous studies have demonstrated that mRNA vaccines can stimulate the immune system to produce antibodies, which help fight infections. This trial tests the BG505 MD39.3 series of vaccines, including BG505 MD39.3 gp151 CD4KO mRNA, BG505 MD39.3 gp151 mRNA, and BG505 MD39.3 mRNA, in separate treatment arms. Early trials indicate that these vaccines can trigger an immune response, suggesting they might help prevent HIV. While more research is needed, these initial results are encouraging for the potential of these vaccines in preventing HIV.13567
Who Is on the Research Team?
Jesse Clark, MD
Principal Investigator
University of California, Los Angeles
Sharon Riddler, MD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
Healthy adults aged 18-55 who are HIV-negative, not pregnant or breastfeeding, and at low risk for HIV infection. They must be willing to use birth control if applicable, have normal blood counts and organ function tests, understand the study requirements, and commit to follow-up visits. Exclusions include poorly controlled hypertension, diabetes (except diet-controlled type 2), previous investigational HIV vaccine recipients (unless placebo), acute illness on vaccination day, recent immunosuppressants or blood products usage.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA, or BG505 MD39.3 gp151 CD4KO mRNA at doses of 100 mcg or 250 mcg, administered via intramuscular injections at months 0, 2, and 6
Safety Evaluation
Sentinel safety groups are evaluated for safety 2 weeks after the first vaccination, with routine safety evaluations throughout the trial
Follow-up
Participants are monitored for safety and effectiveness after treatment, including measurement of serum IgG binding antibodies and CD4+ T-cell responses
What Are the Treatments Tested in This Trial?
Interventions
- BG505 MD39.3 gp151 CD4KO mRNA
- BG505 MD39.3 gp151 mRNA
- BG505 MD39.3 mRNA
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Department of Health and Human Services
Collaborator
National Institutes of Health (NIH)
Collaborator