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Safety and Immunogenicity Study of HIV-MAG Vaccine +/- IL-12 and Ad35-GRIN/ENV in HIV-uninfected Volunteers

NCT01496989 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2013-09-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of multiantigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human IL-12 pDNA (GENEVAX® IL-12) followed or preceded by recombinant Ad35-GRIN/ENV HIV vaccine in low-risk for HIV-uninfected healthy adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

HIV-MAG (3,000mcg)

Delivered intramuscularly by in vivo electroporation

BIOLOGICAL

GENEVAX® IL-12 (100mcg)

Co-administered with HIV-MAG, delivered intramuscularly by in vivo electroporation

BIOLOGICAL

GENEVAX® IL-12 (1000mcg)

Co-administered with HIV-MAG, delivered intramuscular by in vivo electroporation

BIOLOGICAL

Ad35-GRIN/ENV

(2x10\^10vp) Delivered intramuscularly by standard needle injection

Sponsors & Collaborators

  • Auro Vaccines LLC

    collaborator INDUSTRY

  • Ichor Medical Systems Incorporated

    collaborator INDUSTRY

  • International AIDS Vaccine Initiative

    lead NETWORK

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
2011-12-31
Primary Completion
2013-03-31

Countries

  • Kenya
  • Rwanda
  • Uganda

Study Locations

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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 NCT01496989 on ClinicalTrials.gov