IAVI W001

Status:
Phase:I
Principal Investigator(s):Julie McElrath, Omu Anzala, Boris Juelg
Objective: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 AdultsThis 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. Last updated September 15, 2022
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Placebo-controlled, Randomized
Arms and Assigned Interventions
DescriptionBiological: BG505 SOSIP.664 gp140, adjuvanted Dosage of 30ug, Intramuscular administration
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionBiological: BG505 SOSIP.664 gp140, adjuvanted Dosage of 100ug, Intramuscular administration
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionBiological: BG505 SOSIP.664 gp140, adjuvanted Dosage of 300ug, Intramuscular administration
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code: NCT03699241
Related Publications:
cGMP production and analysis of BG505 SOSIP.664, an extensively glycosylated, trimeric HIV‐1 envelope glycoprotein vaccine candidate
IAVI Announces First-in-Human Clinical Trial of Native-like HIV Envelope Vaccine Candidate
Trial Sponsors: IAVI
Start Date
End Date
December 4, 2018
August 30, 2023
Enrollment:61
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women