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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

HIV Infections Clinical Trial

Official title:
A Phase 1 Trial to Evaluate 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 Adult Participants

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of an HIV-1 nef/tat/vif, env pDNA vaccine delivered with electroporation (EP), followed by a recombinant vesicular stomatitis virus (rVSV) HIV envC vaccine boost, in healthy, HIV-uninfected adults.

Clinical Trial Description

This study will evaluate the safety and tolerability of an HIV-1 nef/tat/vif, env pDNA vaccine delivered with EP, followed by a rVSV HIV envC vaccine boost, in healthy, HIV-uninfected adults. Participants will be randomly assigned to one of two groups. Participants in Group 1 will receive the HIV-1 nef/tat/vif, env pDNA vaccine at Day 0 and Months 1 and 3, followed by the rVSV HIV envC vaccine boost at Months 6 and 9. Participants in Group 2 will receive placebo vaccine at Day 0 and Months 1, 3, 6, and 9. Study visits will occur at Day 0, Week 2, and Months 1, 1.5, 3, 3.25, 3.5, 6, 6.25, 6.5, 9, 9.25, 9.5, 12, and 15. Visits may include physical examinations, urine collection, blood collection, HIV testing, risk reduction counseling, assessments, and questionnaires. Participants will be contacted by study staff for follow-up monitoring annually for 3 years following the initial study injection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02654080
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Start date March 2016
Completion date July 1, 2019
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