NCT04177355

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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: Group 7: The same BG505 SOSIP immunogen but with a lower dose (3mcg) of 3M-052-AF + Alum, Group 8: The Trimer 4571 with 5mcg 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. Upon protocol amendment, subjects in Part A were invited to receive a third immunization. Participants in Part B will attend 18 months of scheduled clinic visits. Participants in Part C will attend 18 months of scheduled clinic visits.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	BG505 SOSIP.664 gp140	Administered by IM injection
BIOLOGICAL	Placebo	Administered by IM injection
BIOLOGICAL	3M-052-AF	Administered by IM injection
BIOLOGICAL	CpG 1018	Administered by IM injection
BIOLOGICAL	GLA-LSQ	Administered by IM injection
BIOLOGICAL	Alum (Aluminum Hydroxide Suspension)	Administered by IM injection
BIOLOGICAL	Trimer 4571	Administered by IM injection

Timeline

• Start date: 2020-01-13
• Primary completion: 2024-11-04
• Completion: 2024-11-04
• First posted: 2019-11-26
• Last updated: 2025-09-02
• Results posted: 2025-06-27

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study