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Safety of and Immune Response to a DNA HIV Vaccine Followed by an Adenoviral Vaccine Boost Given Three Different Ways to HIV Uninfected Adults

NCT00384787 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-10-14

No results posted yet for this study

Summary

The purpose of this study is to determine the safety of, immune response to, and tolerability of an adenoviral vector HIV vaccine given after a three-dose regimen of a DNA HIV vaccine. The adenoviral vaccine will be given into arm muscle (intramuscularly), between skin layers (intradermally), or under the skin (subcutaneously).

NOTE: In October 2007, vaccinations with the adenoviral vaccine, VRC-HIVADV014-00-VP, were discontinued. In December 2007, vaccinations with the DNA vaccine were also discontinued. Participants will be followed for safety and immune responses at regular study visits.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

VRC-HIVDNA009-00-VP

HIV DNA vaccine containing the HIV genes gag, pol, nef, and env A,B, and C. The HIV DNA vaccine will be given in three doses intramuscularly at study entry and Months 1 and 2

BIOLOGICAL

VRC-HIVADV014-00-VP

Adenoviral vector HIV booster vaccine containing the HIV genes gag, pol, and env. The adenoviral vector HIV booster vaccine will be administered intramuscularly (Group 1), intradermally (Group 2), or subcutaneously (Group 3) at Month 6

Sponsors & Collaborators

  • HIV Vaccine Trials Network

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Beryl Koblin, PhD · New York Blood Center

  • Martin Casapia, MD · Asociación Civil Impacta Salud y Educación (IMPACTA), Peru

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2008-11-30
Completion
2012-12-31

Countries

  • United States
  • Peru

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 NCT00384787 on ClinicalTrials.gov