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HVTN 120

Status
Ongoing
Phase
I/II
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 participants

Prevention Option(s)
HIV Vaccine
Study Design
Randomized
Arms and Assigned Interventions
Description
100 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 Delivery
Intramuscular
Products
ALVAC/gp120/MF59
ARMs
Experimental
Clade
C
Description
100 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 Delivery
Intramuscular
Products
ALVAC/gp120/AS01(B)
ARMs
Experimental
Clade
C
Description
100 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 Delivery
Intramuscular
Products
ALVAC/gp120/AS01(B)
ARMs
Experimental
Clade
C
Description
20 participants will receive 1 mL of the placebo injection in the left deltoid on Months 0, 1, 3, and 6. They will receive 0.5 mL of the placebo injection and 0.75 mL of a separate placebo injection in the right deltoid on Months 3 and 6.
ARMs
Placebo Comparator
Trial Sponsors
NIAID
March 2018
September 2019
Enrollment
320
18
Years
40
Years
Population
Women
Men
Sites

Soweto

South Africa

Durban

South Africa

Mbeya Med. Research Program, Mbeya Referral Hospital CRS

Mbeya
United Republic of Tanzania

Klerksdorp

South Africa

Soshanguve

South Africa

The Aurum Institute, Tembisa Hospital

Tembisa
South Africa

Seke South Clinical Research Site

Harare
Zimbabwe

Site(s) - Brits

South Africa

Site(s) - Ladysmith

South Africa

Matero

Lusaka
Zambia

Bridge HIV CRS

San Francisco, California
United States of America

Hope Clinic of the Emory Vaccine Center CRS

Decatur, Georgia
United States of America

Fenway Health (FH) CRS

Boston, Massachusetts
United States of America

Columbia P&S CRS

New York, NY
United States of America

University of Rochester HVTN CRS

Rochester, New York
United States of America

Case CRS

Cleveland, Ohio
United States of America

Vanderbilt Vaccine CRS

Nashville, Tennessee
United States of America