HVTN 303

Principal Investigator(s):Dr. Jesse Clark
Objective:Protocol overview presented on June 15,  2022 at National Vaccine Advisory Meeting by Dr. Jesse Clark (UCLA) Full title: Phase 1, open-label clinical trial to evaluate safety, tolerability, and immunogenicity of adjuvanted HIV-1 fusion peptide conjugate vaccine (VRC-HIVVCP0108-00-VP) alone or in prime-boost regimens with adjuvanted HIV-1 envelope trimer 4571 (VRC-HIVRGP096-00-VP) and HIV-1 Trimer 6931 (VRC-HIVRGP0106-00-VP) vaccines in healthy adultsPart ASafety, tolerability, immunogenicity of single doses of fusion peptide conjugate, Trimer 4571 and Trimer 6931 vaccines in a dose escalation design (each product must be assessed as safe prior to use in Part B; Trimer 4571 with alum adjuvant has been previously evaluated in humans but will be tested in Part A with Adjuplex)Part BSafety, tolerability, immunogenicity of fusion peptide conjugate prime, Trimer 4571 prime, or an FP + Trimer 4571 prime, all followed by subsequent doses of Trimer 4571, Trimer 6931 and both Trimers combined Last updated June 15, 2022
Prevention Option(s):HIV Vaccine
Study Design:Open label
Trial Sponsors: HVTN
Start Date
End Date
Age range: ↔ any
Population:Cisgender Men, Cisgender Women