Principal Investigator(s):Marina Caskey, Godelieve de Bree, David Joseph Diemert
Objective: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 AdultsThis 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.Last updated September 16, 2022
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Placebo-controlled, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Investigational Product, 30 µg/ Placebo 30 µg IM, months 0, 2 and 6
Mode of DeliveryIntramuscular
DescriptionExperimental: Investigational Product, 300 µg/ Placebo 300 µg IM, months 0, 2 and 6
Mode of DeliveryIntramuscular
Official Code: NCT04224701
Trial Sponsors: GSK, IAVI
Start Date
End Date
August 1, 2020
December 1, 2023
Age range: 18 ↔ 51 Years
Population:Cisgender Men, Cisgender Women