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Evaluating the Safety of and Immune Response to an HIV Vaccine Followed by Booster, Administered by Two Devices, in HIV-Uninfected Adults

NCT01260727 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2021-11-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of and immune response to an HIV vaccine, administered using two different devices, followed by a vaccine boost, in healthy, HIV-uninfected adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

PENNVAX-G DNA Vaccine

PENNVAX-G DNA (HIV-1 env A, C, and D, and consensus gag plasmids) vaccine; 4 mg administered IM as a total volume of 1 mL

BIOLOGICAL

MVA-CMDR Vaccine

MVA-CMDR live attenuated modified vaccinia ankara vector (HIV-1 CM235 env/CM240 gag/pol); 1 x 10\^8 plaque-forming unit (pfu) administered IM by needle and syringe as a volume of 1 mL in either deltoid

BIOLOGICAL

Placebo PENNVAX-G Vaccine

Sodium Chloride Injection USP, 0.9%

BIOLOGICAL

Placebo MVA-CMDR Vaccine

Sodium Chloride Injection USP, 0.9%

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • MAJ Julie Ake, MD · U.S. Military HIV Research Program (MHRP)/Walter Reed Army Institute of Research (WRAIR)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2013-12-31
Completion
2015-06-30

Countries

  • United States
  • Kenya
  • Tanzania
  • 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 NCT01260727 on ClinicalTrials.gov