NCT04224701

A Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505 SOSIP.GT1.1 Gp140 Vaccine, Adjuvanted in Healthy, HIV-uninfected Adults

A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505 SOSIP.GT1.1 Gp140 Vaccine, Adjuvanted in Healthy, HIV-uninfected Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 51 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 trimer Vaccine, Adjuvanted, in up to 48 healthy HIV-uninfected adult volunteers.

Detailed description

This is a phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 trimer Vaccine, Adjuvanted, in up to 48 healthy HIV-uninfected adult volunteers. BG505 SOSIP.GT1.1 is a soluable, cleavage-competent, trimeric HIV-1 envelope glycoprotein gp140 formulated in 0.55mL at 2mg/mL in 20 mM Tris, 100 mM naCL, pH 7.5 and will be administered IM.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted	30 µg
BIOLOGICAL	BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted	300 µg
BIOLOGICAL	Placebo	Tris NaCl Diluent

Timeline

• Start date: 2020-08-01
• Primary completion: 2023-07-05
• Completion: 2023-08-02
• First posted: 2020-01-13
• Last updated: 2024-12-05

Locations

3 sites across 2 countries: United States, Netherlands

Regulatory

• FDA-regulated drug study