132
Participants
Start Date
June 19, 2017
Primary Completion Date
December 12, 2019
Study Completion Date
December 12, 2019
ALVAC-HIV (vCP2438)
Expresses the gene products ZM96 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane (TM) anchor sequence of gp41 (28 amino acids clade B LAI strain) and gag and pro (clade B LAI strain); formulated as a lyophilized vaccine for injection at a viral titer ≥ 1 × 10\^6 cell culture infectious dose (CCID)50 and \< 1 × 10\^8 CCID50 (nominal dose of 10\^7 CCID50) and reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for intramuscular (IM) injection as a single dose
Bivalent Subtype C gp120/MF59
Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant (an oil-in-water emulsion); delivered as a 0.5 mL IM injection
Bivalent Subtype C gp120 admixed with Al(OH)3 Suspension
Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, admixed with Aluminum Hydroxide Suspension (\~625 mcg aluminum content); delivered as a 0.5 mL IM injection
Bivalent Subtype C gp120
Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, mixed with sodium chloride for injection, 0.9%; delivered as a 0.5 mL IM injection
Aurum Tembisa CRS, Johannesburg
Soweto HVTN CRS, Johannesburg
eThekwini CRS, Durban
Emavundleni CRS, Cape Town
Polana Canico Health Research and Training Center (CISPOC), National Institute of Health (INS) CRS, Maputo
Seke South CRS, Chitungwiza
Collaborators (1)
HIV Vaccine Trials Network
NETWORK
Sanofi Pasteur, a Sanofi Company
INDUSTRY
GlaxoSmithKline
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH