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HVTN Protocol 204 - A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Boost, VRCHIVADV014-00-VP, in HIV-1 Uninfected Adult Participants

NCT00125970 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2021-10-15

No results posted yet for this study

Summary

The purpose of the study is to determine the safety of and immune response to a DNA HIV vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

VRC-HIVDNA016-00-VP

4 mg administered in deltoid

BIOLOGICAL

VRC-HIVADV014-00-VP

1 x 10\^10 PU administered in deltoid

BIOLOGICAL

VRC-HIVDNA016-00-VP placebo

1 mL administered at study entry and Months 1 and 2

BIOLOGICAL

VRC-HIVADV014-00-VP placebo

1 mL administered at Month 6

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Michael Keefer, MD · University of Rochester

  • Gavin Churchyard, MBBCh, FCP, MMed, PhD · Aurum Health Research Limited

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
2005-09-30
Primary Completion
2008-02-29
Completion
2010-01-31

Countries

  • United States
  • Brazil
  • Haiti
  • Jamaica
  • South Africa

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 NCT00125970 on ClinicalTrials.gov