Evaluating the Safety, Tolerability, and Immunogenicity of a Prime-Boost Regimen of HIV-1 Nef/Tat/Vif, Env pDNA Vaccine Delivered Intramuscularly With Electroporation and HIV-1 rVSV envC Vaccine in Healthy, HIV-Uninfected Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

August 24, 2017

Study Completion Date

July 1, 2019

Conditions
HIV Infections
Interventions
BIOLOGICAL

HIV-1 nef/tat/vif, env pDNA vaccine

1500 mcg to be administered as 0.5 mL intramuscular (IM) in the deltoid of the non-dominant arm (unless medically contraindicated) using the Ichor Medical Systems TDS EP device

BIOLOGICAL

rVSV HIV envC vaccine

1 × 10\^7 PFU to be administered as 1 mL IM in the deltoid of the non-dominant arm (unless medically contraindicated)

BIOLOGICAL

Placebo

"Sodium Chloride for Injection, USP 0.9%;~At Months 0, 1, and 3: administered as 0.5 mL IM in the deltoid of the non-dominant arm (unless medically contraindicated) using the Ichor Medical Systems TDS EP device.~At Months 6 and 9: administered as 1 mL IM in the deltoid of the non-dominant arm (unless medically contraindicated)."

Trial Locations (2)

19104

Penn Prevention CRS, Philadelphia

44106

Case Clinical Research Site, Cleveland

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02654080 - Evaluating the Safety, Tolerability, and Immunogenicity of a Prime-Boost Regimen of HIV-1 Nef/Tat/Vif, Env pDNA Vaccine Delivered Intramuscularly With Electroporation and HIV-1 rVSV envC Vaccine in Healthy, HIV-Uninfected Adults | Biotech Hunter | Biotech Hunter