Synthetic DNA + Protein Boosts Vaccine for HIV Protection
Trial Summary
What is the purpose of this trial?
This is an open-label study to examine the safety and immunogenicity of synthetic DNAs encoding NP-GT8 and IL-12 with or without a TLR-agonist-adjuvanted Env Trimer 4571 boost in adults without HIV. The primary hypothesis is that vaccination with a recombinant DNA vaccine encoding a germline-targeting epitope followed by a trimeric protein boost will be safe and immunogenic.
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, certain medications that might impair immune response or recent vaccinations could affect eligibility, so it's best to discuss your specific situation with the trial team.
What data supports the effectiveness of the treatment 3M-052-AF, IL-12 DNA, sD-NP-GT8 DNA, Trimer 4571 for HIV protection?
Research shows that DNA vaccines, like those used in the treatment, can trigger strong immune responses in animals and humans, which are important for fighting HIV. Studies have found that adding components like IL-12 can enhance these immune responses, suggesting potential effectiveness in HIV protection.12345
Is the synthetic DNA and protein vaccine for HIV generally safe in humans?
The research indicates that DNA vaccines, including those with synthetic components, have been tested in humans and animals, showing immune responses without major safety concerns. However, specific safety data for the exact combination of synthetic DNA and protein in humans is not detailed in the available studies.23567
How does the treatment IL-12 DNA, sD-NP-GT8 DNA differ from other HIV treatments?
This treatment is unique because it uses synthetic DNA with optimized codon usage to enhance the immune response, which is further boosted by a protein component. This approach aims to induce stronger and broader antibody responses compared to traditional methods, potentially offering better protection against HIV.5891011
Eligibility Criteria
Adults aged 18-55, in good health with stable blood pressure and no history of severe allergies or chronic conditions that could affect the trial. Must not be pregnant, breastfeeding, or at high risk for HIV. Participants should agree to use birth control and avoid other clinical trials during this study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 3 administrations of sD-NP-GT8 DNA coformulated with IL-12 DNA, with or without Trimer 4571 boost
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- 3M-052-AF
- IL-12 DNA
- sD-NP-GT8 DNA
- Trimer 4571
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Inovio Pharmaceutical Inc.
Collaborator
Access to Advanced Health Institute (AAHI)
Collaborator
Inovio Pharmaceuticals
Industry Sponsor
The Betty and Dale Bumpers Vaccine Research Center (VRC)
Collaborator
Access to Advanced Health Institute (AAHI)
Collaborator
HIV Vaccine Trials Network
Collaborator
Department of Health and Human Services
Collaborator
The Wistar Institute
Collaborator