HVTN 120/ ALVAC-HIV
Status:Completed
Phase:I/II
Principal Investigator(s):Z Mike Chirenje
Objective:A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult participantsLast updated January 31, 2022
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
Description100 participants will receive 1 mL ALVAC-HIV injection in the left deltoid on Months 0, 1, 3, and 6. They will receive 0.5 mL100 mcg Protein/MF59 and 0.75 mL placebo injection in the right deltoid on Months 3 and 6.
Mode of DeliveryIntramuscular
ARMsExperimental
Description100 participants will receive 1 mL ALVAC-HIV injection in the left deltoid on Months 0, 1, 3, and 6. They will receive 0.75 mL100 mcg Protein/AS01(B) and 0.5 mL placebo injection in the right deltoid on Months 3 and 6.
Mode of DeliveryIntramuscular
ARMsExperimental
Description100 participants will receive 1 mL ALVAC-HIV injection in the left deltoid on Months 0, 1, 3, and 6. They will receive 0.75 mL 20 mcg Protein/AS01(B) and 0.5 mL placebo injection in the right deltoid on Months 3 and 6.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT03122223
Trial Sponsors:
NIAID (DAIDS-ES: 36128)
Start Date
End Date
January 16, 2018
July 30, 2020
Enrollment:160
Age range:
18 Years ↔
40 Years
Population:Cisgender Men, Cisgender Women