Evaluating the Safety of and Immune Response to an HIV Vaccine in Healthy, HIV-Uninfected Adults in Uganda

HIV Infections Clinical Trial

Official title:
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 Recombinant Adenovirus-5 Vector Vaccine, VRC-HIVADV014-00-VP Administered Alone or Administered as a Boost to a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP, in Uninfected Adult Volunteers in Uganda

Status Completed

Clinical Trial Summary

The RV 156A clinical trial is evaluating an experimental HIV vaccine in people who are not infected with HIV. Participants in that study are randomly assigned to receive either the HIV vaccine or placebo. This study will enroll people who are participating in the RV 156 study. In this study, researchers will evaluate the safety of and immune response to a different experimental HIV vaccine in people who participated in the RV 156 study.

Clinical Trial Description

RV 156A is a single site, phase 1 open label study with accrual restricted to participants in RV 156. Participants in the RV 156 study were randomly assigned to receive three injections of either placebo or the VRC-HIVDNA009-00-VP vaccine. All participants in this study will receive one injection of a different experimental HIV vaccine, VRC-HIVADV014-00-VP. The purpose of this study is to evaluate the safety and immunogenicity of the VRC-HIVADV014-00-VP vaccine in people who participated in the RV 156 study. Researchers will examine the differences in the immune response to the VRC-HIVADV014-00-VP vaccine between people who received placebo in the RV 156 study and people who received the VRC-HIVDNA009-00-VP vaccine in the RV 156 study. A projected number of up to 29 volunteers will be enrolled from the Makerere University site in Uganda. At study entry, all participants will undergo a physical examination, medical history review, vital sign measurements, and blood and urine collection. They will also receive counseling for HIV prevention and pregnancy prevention. Participants will then receive one injection of the VRC-HIVADV014-00-VP vaccine in their upper arm. They will remain in the clinic for 30 to 45 minutes for observation and monitoring. For 3 days after the vaccination, participants will record their temperature and any adverse symptoms in a diary. Additional study visits will occur at Days 3, 14, 28, 42, 84, 168, 252, and 336. At each visit, participants will undergo the same study procedures that they completed at the study entry visit. ;

Study Design

Related Conditions & MeSH terms

HIV Infections

Clinical Trial Details

NCT number	NCT01549509
Study type	Interventional
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	Phase 1
Start date	April 2007
Completion date	October 2009

View Details

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