A Safety and Immune Response Study of 2 Experimental HIV Vaccines

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

February 2, 2015

Primary Completion Date

August 7, 2018

Study Completion Date

August 7, 2018

Conditions
HIV Infection
Interventions
BIOLOGICAL

ALVAC-HIV

a lyophilized vaccine for injection at a viral titer ≥ 1 × 10E6 cell culture infectious dose (CCID)50 and \< 1 × 10E8 CCID50 (nominal dose of 10E7 CCID50) and is reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for intramuscular (IM) injection as a single dose.

BIOLOGICAL

Bivalent Subtype C gp120/MF59®

2 recombinant monomeric proteins, each at a dose of 100 mcg, mixed with MF59® adjuvant (an oil-in-water emulsion) delivered as a 0.5 mL IM injection

BIOLOGICAL

ALVAC-HIV (vCP2438) Placebo

a sterile, lyophilized product that consists of a mixture of virus stabilizer, and freeze drying medium and is reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for injection as a single dose IM

BIOLOGICAL

Bivalent gp120/MF59® Placebo

Sodium chloride for injection, 0,9% delivered as a 0.5 mL IM injection

Trial Locations (5)

2013

Perinatal HIV Research Unit, Soweto

2570

Aurum Institute for Health Research, Klerksdorp

4001

CAPRISA eThekwini CRS, Durban

4133

Isipingo CRS, Durban

7750

Emavundleni Desmond Tutu HIV Centre CRS, Cape Town

All Listed Sponsors
collaborator

HIV Vaccine Trials Network

NETWORK

collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

Medical Research Council

OTHER_GOV

collaborator

Sanofi Pasteur, a Sanofi Company

INDUSTRY

collaborator

GlaxoSmithKline

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH