Safety and Immune Response to a Clade C DNA HIV Vaccine

PHASE1CompletedINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

June 21, 2016

Primary Completion Date

July 11, 2018

Study Completion Date

July 11, 2018

Conditions
HIV Infections
Interventions
BIOLOGICAL

DNA-HIV-PT123 vaccine

Contains a mixture of 3 DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C ZM96 gag, 2) clade C ZM96 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose 4 mg administered as 1 mL intramuscularly (IM)

BIOLOGICAL

Protein/MF59 vaccine

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 as 0.5 mL IM

BIOLOGICAL

Placebo

Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products

Trial Locations (5)

1632

Aurum Tembisa CRS, Johannesburg

2571

Aurum Institute Klerksdorp CRS, Klerksdorp

3630

Isipingo CRS, Westville

Unknown

National Institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC) Network CRS, Mbeya

Matero Reference Clinic CRS, Lusaka

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

HIV Vaccine Trials Network

NETWORK

collaborator

IPPOX Foundation

OTHER

collaborator

Novartis Vaccines

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH