252
Participants
Start Date
February 2, 2015
Primary Completion Date
August 7, 2018
Study Completion Date
August 7, 2018
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.
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
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
Bivalent gp120/MF59® Placebo
Sodium chloride for injection, 0,9% delivered as a 0.5 mL IM injection
Perinatal HIV Research Unit, Soweto
Aurum Institute for Health Research, Klerksdorp
CAPRISA eThekwini CRS, Durban
Isipingo CRS, Durban
Emavundleni Desmond Tutu HIV Centre CRS, Cape Town
Collaborators (2)
HIV Vaccine Trials Network
NETWORK
Bill and Melinda Gates Foundation
OTHER
Medical Research Council
OTHER_GOV
Sanofi Pasteur, a Sanofi Company
INDUSTRY
GlaxoSmithKline
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH