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HVTN 702

Status
Ongoing
Phase
III
IIb
Principal Investigator(s)
Glenda Gray, MBBCH, FCPaed (SA)
Objective

This study will evaluate the preventive vaccine efficacy, safety, and tolerability of ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 in HIV-seronegative South African adults over 24 months and potentially up to 36 months from enrollment.

Prevention Option(s)
HIV Vaccine
Study Design
Double-blind
Arms and Assigned Interventions
Description
Active Comparator: ALVAC-HIV + subtype C gp120/MF59 2700 participants will receive an IM injection of ALVAC-HIV (vCP2438) at months 0 and 1, and an IM injection of ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 at months 3, 6, and 12.
Mode of Delivery
Intermuscular
Products
ALVAC
gp120
ARMs
Experimental
Clade
C
Description
Placebo Comparator: Placebo 2700 participants will receive Sodium Chloride for injection, 0.9% at months 0, 1, 3, 6, and 12.
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Trial Sponsors
NIAID
November 2016
July 2021
Enrollment
5 400
18
Years
35
Years
Population
Women
Men
Sites

Madibeng Centre for Research

Brits
South Africa

Emavundleni (EMA) CRS

Cape Town
South Africa

Khayelitsha CRS

Cape Town
South Africa

eThekwini CRS

Durban, KwaZulu-Natal
South Africa

Isipingo CRS

Westville, KwaZulu-Natal
South Africa

Verulam CRS

Verulam, KwaZulu-Natal
South Africa

Klerksdorp

South Africa

Aurum Institute

Klerksdorp
South Africa

Soweto HVTN CRS

Johannesburg
South Africa

Rustenburg CRS

Rustenburg
South Africa

Setshaba Research Centre

Shoshanguve
South Africa

Kliptown

Soweto
South Africa

The Aurum Institute, Tembisa Hospital

Tembisa
South Africa

MeCRU CRS

Pretoria
South Africa

Qhakaza Mbokodo Research Clinic

Ladysmith
South Africa