160
Participants
Start Date
January 16, 2018
Primary Completion Date
July 30, 2020
Study Completion Date
July 30, 2020
ALVAC-HIV (vCP2438)
expresses the gene products 96ZM651 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 viral titer greater than or equal to 1 × 10\^6 cell culture infectious dose (CCID)50 and less than 1 × 10\^8 CCID50 (nominal dose of 10\^7 CCID50) and is reconstituted with 1 mL of sterile sodium chloride solution (NaCl 0.4%), administered IM as a single 1 mL dose.
Bivalent subtype C gp120/MF59
clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered IM as a single 0.5 mL dose.
Bivalent subtype C gp120/AS01(B)
clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 20 mcg or 100 mcg, mixed with AS01B adjuvant, administered IM as a single 0.75 mL dose.
Placebo
Sodium Chloride for Injection, 0.9%, administered IM.
Matero Reference Clinic CRS, Lusaka
University of Rochester Vaccines to Prevent HIV Infection CRS, Rochester
Penn Prevention CRS, Philadelphia
The Hope Clinic of the Emory Vaccine Center CRS, Decatur
Case Clinical Research Site, Cleveland
Bridge HIV CRS, San Francisco
Brigham and Women's Hospital Vaccine CRS (BWH VCRS), Boston
Fenway Health (FH) CRS, Boston
Vanderbilt Vaccine (VV) CRS, Nashville
Seattle Vaccine and Prevention CRS, Seattle
National Institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC) Network CRS, Mbeya
Seke South CRS, Chitungwiza
Collaborators (1)
GlaxoSmithKline
INDUSTRY
Sanofi Pasteur, a Sanofi Company
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH