MedTrace Logo

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

NCT02654080 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-10-15

No results posted yet for this study

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.

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).

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Greg Wilson · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-08-24
Completion
2019-07-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02654080 on ClinicalTrials.gov