Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected Adults
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HIV Infections
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 50 years
- Gender
- Both males and females
Description
This study will evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults. The study will be conducted in two parts (Part A and B). Part A will include two groups (Groups 1 and 2) and Part B will include four groups...
This study will evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults. The study will be conducted in two parts (Part A and B). Part A will include two groups (Groups 1 and 2) and Part B will include four groups (Groups 3, 4, 5, and 6). Participants in Part A will be randomly assigned to receive the BG505 SOSIP.664 gp140 vaccine admixed with 3M-052-AF and alum adjuvant or to receive placebo. Part A participants will be enrolled sequentially in Groups 1 and 2 for dose escalation. Participants in Part B will be randomly assigned to Groups 3, 4, 5, or 6, to receive the BG505 SOSIP.664 gp140 vaccine with an adjuvant (the specific adjuvant will vary by group) or to receive placebo. Participants in Part A will attend 8 months of scheduled clinic visits, and they will be contacted by study staff at Month 14 for follow-up health monitoring. Participants in Part B will attend 18 months of scheduled clinic visits.
Tracking Information
- NCT #
- NCT04177355
- Collaborators
- HIV Vaccine Trials Network
- International AIDS Vaccine Initiative
- Infectious Disease Research Institute (IDRI)
- Dynavax Technologies Corporation
- Fred Hutchinson Cancer Research Center
- Investigators
- Study Chair: M. Juliana McElrath Seattle Vaccine Trials Unit Study Chair: Nadine Rouphael Emory University
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