NCT03699241

A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV Envelope Protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in Healthy, HIV-1 Uninfected Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This a phase 1 first-in-human clinical trial to evaluate the safety, tolerability, and immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in up to 60 healthy adult HIV-uninfected volunteers.

Detailed description

This a phase 1 first-in-human clinical trial to evaluate the safety, tolerability, and immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in up to 60 healthy adult HIV-uninfected volunteers. BG505 SOSIP.664 gp140 is a stable, soluble, cleaved HIV envelope trimer 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.664 gp140, adjuvanted	Dosage of 30ug, Intramuscular administration
BIOLOGICAL	BG505 SOSIP.664 gp140, adjuvanted	Dosage of 100ug, Intramuscular administration
BIOLOGICAL	BG505 SOSIP.664 gp140, adjuvanted	Dosage of 300ug, Intramuscular administration
BIOLOGICAL	Placebo	Tris-NaCl Diluent

Timeline

• Start date: 2018-12-03
• Primary completion: 2023-03-21
• Completion: 2023-07-11
• First posted: 2018-10-09
• Last updated: 2023-12-14

Locations

3 sites across 2 countries: United States, Kenya

Regulatory

• FDA-regulated drug study