HVTN 107/ ALVAC-HIV (vCP2438)
Status:Ongoing
Phase:I/II
Principal Investigator(s):Paul Goepfert, Kathy Mngadi
Objective:The purpose of this study is to evaluate the safety and immune response to an HIV clade C vaccine and to an MF59- or alum-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.
Last updated February 27, 2021
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionActive Comparator: Group 1: ALVAC-HIV + gp120/MF59
Participants will receive the ALVAC-HIV (vCP2438) vaccine in the left deltoid at months 0, 1, 3, 6, and 12, and Bivalent Subtype C gp120/MF59 in the right deltoid at months 3, 6, and 12.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionActive Comparator: Group 2: ALVAC-HIV + gp120/Al(OH)3
Participants will receive the ALVAC-HIV (vCP2438) vaccine in the left deltoid at months 0, 1, 3, 6, and 12, and Bivalent Subtype C gp120 admixed with Al(OH)3 Suspension in the right deltoid at months 3, 6, and 12.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionActive Comparator: Group 3: ALVAC-HIV + gp120/MF59
Participants will receive the ALVAC-HIV (vCP2438) vaccine in the left deltoid and Bivalent Subtype C gp120/MF59 in the right deltoid at months 0, 1, 6, and 12.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionActive Comparator: Group 4: ALVAC-HIV + gp120
Participants will receive the ALVAC-HIV (vCP2438) vaccine in the left deltoid at months 0, 1, 3, 6, and 12, and Bivalent Subtype C gp120 in the right deltoid at months 3, 6, and 12.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT03284710
Trial Sponsors:
NIAID
Start Date
End Date
July 19, 2017
December 12, 2019
Enrollment:132
Age range:
18 Years ↔
40 Years
Population:Cisgender Men, Cisgender Women