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Safety of and Immune Response to an HIV-1 Vaccine (VRC-HIVDNA016-00-VP) and a Vaccine Booster (VRC-HIVADV014-00-VP) in HIV Uninfected East African Adults

NCT00123968 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2021-11-09

No results posted yet for this study

Summary

The purpose of the study is to determine the safety of and immune response to an investigational HIV vaccine, VRC-HIVDNA016-00-VP, and a vaccine booster, VRC-HIVADV014-00-VP, in HIV uninfected adults from Kenya, Tanzania, and Uganda.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

VRC-HIVDNA016-00-VP

1x10\^11 per unit vaccine administered intramuscularly via Bioinjector

BIOLOGICAL

VRC-HIVADV014-00-VP

4 mg administered intramuscularly via injection

BIOLOGICAL

VRC-DILUENT013-DIL-VP

Administered intramuscularly via Bioinjector

BIOLOGICAL

VRC-HIVADV014-00-VP placebo

4 mg administered intramuscularly via injection

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Merlin Robb, MD · US Military HIV Research Program

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • 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 NCT00123968 on ClinicalTrials.gov