Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

June 19, 2017

Primary Completion Date

December 12, 2019

Study Completion Date

December 12, 2019

Conditions
HIV Infections
Interventions
BIOLOGICAL

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

BIOLOGICAL

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

BIOLOGICAL

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

BIOLOGICAL

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

Trial Locations (6)

1632

Aurum Tembisa CRS, Johannesburg

1862

Soweto HVTN CRS, Johannesburg

4013

eThekwini CRS, Durban

7750

Emavundleni CRS, Cape Town

Unknown

Polana Canico Health Research and Training Center (CISPOC), National Institute of Health (INS) CRS, Maputo

Seke South CRS, Chitungwiza

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

HIV Vaccine Trials Network

NETWORK

collaborator

Sanofi Pasteur, a Sanofi Company

INDUSTRY

collaborator

GlaxoSmithKline

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03284710 - Safety and Immunogenicity of Clade C ALVAC and gp120 HIV Vaccine | Biotech Hunter | Biotech Hunter