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Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected Adults

HIV Infections Clinical Trial

Official title:
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Aalum Adjuvants and VRC HIV Env Trimer 4571 and 3M-052-AF With Alum in Healthy, HIV-uninfected Adults

Clinical Trial Summary

The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults.

Clinical Trial 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 three parts (Part A, B and C). Part A will include two groups (Groups 1 and 2), Part B will include four groups (Groups 3, 4, 5, and 6) and Part C will include two groups (Groups 7 and 8). 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 C will be randomly assigned to Groups 7 or 8 to receive the Trimer 4571 (BG505 SOSIP.664 DS gp140) with 3M-052-AF + Alum 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. Participants in Part C will attend 18 months of scheduled clinic visits. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04177355
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Active, not recruiting
Phase Phase 1
Start date January 13, 2020
Completion date November 4, 2024
View Details
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