HIV Vaccine + Adjuvant for HIV Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a potential vaccine for preventing HIV, focusing on its safety and ability to trigger an immune response in healthy adults. Researchers test different doses and methods of administering the vaccine to find the safest and most effective approach. The trial divides participants into groups, each trying different methods. Individuals who are HIV-negative, generally healthy, and interested in contributing to HIV prevention might be a good fit for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, helping researchers understand its effects in people.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like immunosuppressive drugs, recent vaccines, and treatments for specific conditions may affect eligibility. It's best to discuss your current medications with the trial team to determine if they might impact your participation.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like immunosuppressive drugs and recent vaccines may affect eligibility, so it's best to discuss your specific situation with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the N332-GT5 gp140, a component of the HIV vaccine under testing, remains in the early stages of human trials. Detailed safety information is not yet available. However, earlier studies have demonstrated promising safety results for the saponin/MPLA nanoparticles (SMNP), which enhance the immune response to the vaccine. These studies found that SMNP was well-tolerated in pre-human tests.
The current study seeks to determine a safe dose and method for administering the vaccine and adjuvant. As a phase 1 trial, the primary goal is to ensure safety for participants. Although clear data on human side effects is not yet available, the study is carefully designed to minimize risks. Participants will be closely monitored to address any side effects promptly.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the N332-GT5 gp140 and SMNP treatments because they represent a novel approach to HIV prevention. Unlike standard HIV treatments that focus on managing the virus in infected individuals, these investigational treatments aim to prevent infection altogether by stimulating the immune system to produce protective antibodies before exposure. The combination of N332-GT5 gp140, a designed protein, with the SMNP adjuvant potentially enhances the immune response, distinguishing it from existing vaccines that lack this specific targeting mechanism. This could lead to a more effective preventative strategy against HIV, sparking hope for a significant advancement in global HIV prevention efforts.
What evidence suggests that this trial's treatments could be effective for HIV prevention?
Research has shown that the N332-GT5 gp140 trimer, an investigational treatment in this trial, helps the immune system recognize and fight HIV by activating certain B cells, which protect the body from infections. Another treatment option in this trial, the adjuvant SMNP, is used with the trimer to further enhance this immune response. Animal studies demonstrated that SMNP improves the body's ability to remember and respond to HIV-like threats. These findings suggest that this combination could be an important step toward preventing HIV infection.12456
Who Is on the Research Team?
Lindsey Baden
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
Adults aged 18-55, in good health with a low risk of HIV, can join this trial. They must have normal blood counts and organ function tests, live near a participating research site, and commit to the study's duration. Those with certain cancers or lymph disorders cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive N332-GT5 gp140 HIV trimer protein adjuvanted with SMNP via subcutaneous or intramuscular route, with 2 bolus immunizations or fractionated escalating dose prime followed by a bolus immunization boost
Follow-up
Participants are monitored for safety and effectiveness after treatment, including planned safety holds and Adverse Event of Special Interest (AESI) health contact 1 year after last vaccination
What Are the Treatments Tested in This Trial?
Interventions
- N332-GT5 gp140
- SMNP
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
Department of Health and Human Services
Collaborator