5,404
Participants
Start Date
October 26, 2016
Primary Completion Date
November 16, 2021
Study Completion Date
November 16, 2021
ALVAC-HIV (vCP2438)
Expresses the gene products ZM96 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane anchor (TM) sequence of gp41 (28 amino acids clade B LAI strain) and gag and pro (clade B LAI strain). It is formulated as a lyophilized vaccine for injection at a dose \> 10\^6 cell culture infectious dose 50% (CCIDv50) and \< 1 × 10\^8 CCIDv50 (nominal dose of 10\^7 CCIDv50) and is reconstituted with 1 mL of sterile sodium chloride solution (NaCl 0.4%) delivered IM
Bivalent Subtype C gp120/MF59
Subtype C TV1.C gp120 Env and 1086.C gp120 Env proteins, each at a dose of 100 mcg, mixed with MF59 adjuvant (an oil-in-water emulsion) and delivered IM
Placebo
Sodium Chloride for injection, 0.9% delivered IM
Kliptown Soweto CRS, Johannesburg
Aurum Tembisa CRS, Johannesburg
Soweto HVTN CRS, Johannesburg
Aurum Institute Klerksdorp CRS, Klerksdorp
Qhakaza Mbokodo Research Clinic CRS, Ladysmith
eThekwini CRS, Durban
Isipingo CRS, Isipingo
Walter Sisulu University HIV Vaccine Research Unit CRS, Mthatha
Emavundleni CRS, Cape Town
Khayelitsha CRS, Cape Town
MeCRU CRS, Pretoria
Setshaba Research Centre CRS, Soshanguve
Verulam CRS, Verulam
Rustenburg CRS, Rustenburg
Collaborators (2)
Sanofi
INDUSTRY
GlaxoSmithKline
INDUSTRY
Bill and Melinda Gates Foundation
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH