NCT05983874

A Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, Given to a Population of Adults Who Have Received 3 Doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted

An Open-Label Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, Given to a Population of Adults in Good General Health Who Have Received 3 Doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 51 Years
• Healthy volunteers: Accepted

Summary

An Open-Label Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, given to a Population of Adults in Good General Health Who have Received 3 doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted

Detailed description

The study population is comprised of adults in good general health who meet all protocol inclusion criteria and do not meet any protocol exclusion criteria and who understand the study and provide written informed consent. Up to 8 participants who received 3 doses of 300µg of BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted, from the AMC clinical site in IAVI C101 (NCT04224701) will be enrolled in the study. BG505 SOSIP.664 gp140 is a stable, soluble, cleaved HIV envelope trimer formulated in 0.55mL at 2mg/mL in 20 mM Tris, 100mM Sodium Chloride (NaCl), pH 7.5 and will be administered intramuscular (IM). BG505 SOSIP.664 gp140 will be diluted in 20 mM Tris, 100 mM NaCl, pH 7.5 (Tris NaCl Diluent). The 3M-052-AF is provided by AAHI. 3M-052-AF is provided in 2mL vials, with a fill volume of 0.4mL at a concentration of 50µg/mL. 3M 052 AF is a clear-to-slightly hazy, colorless liquid. Aluminum hydroxide suspension 2% is a pyrogen free, sterilized aluminum hydroxide wet gel suspension, placed into 2 mL Type 1 vials, containing an aluminum concentration of 10 mg/mL. It appears as an opaque white gelatinous precipitate in aqueous suspension. All administrations of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted will be given IM in a 0.5mL volume. The study product is described in detail in the Investigators Brochure. All products slated for use in the Netherlands will have EU-compliant labels.

Conditions

• Hiv

Interventions

Type	Name	Description
BIOLOGICAL	BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) Dosage	100µg Month 0 and Month 3

Timeline

• Start date: 2024-04-16
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2023-08-09
• Last updated: 2024-06-11

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study