Safety of and Immune Response to an Experimental HIV Vaccine (VRC-HIVADV014-00-VP) in HIV Uninfected Adults
The purpose of this study is to determine the safety of and immune response to an experimental HIV vaccine in HIV uninfected individuals.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||A Phase I Dose-Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade, Multivalent Recombinant Adenoviral Vector HIV Vaccine, VRC-HIVADV014-00-VP, in Healthy, HIV-1 Uninfected Adult Participants Who Have Low Titers of Pre-Existing Ad5 Neutralizing Antibodies|
- Blood and chemical parameters for 12 months after injection
- Local and systemic adverse reactions for 12 months after injection
|Study Completion Date:||October 2006|
The HIV epidemic is a major global health challenge. People in developing nations have limited access to life-sustaining antiretrovirals and account for over 95% of the 5 million new HIV infections annually. The development of a safe, effective, and widely accessible HIV vaccine is paramount in these areas. The adenoviral vector vaccine VRC-HIVADV014-00-VP has been shown to elicit a CD8 cytotoxic lymphocyte (CTL) response believed to be crucial in an effective preventive HIV vaccine. The purpose of this study is to determine the safety and immunogenicity of VRC-HIVADV014-00-VP in HIV uninfected adults. In this study, HIV uninfected individuals with low levels of pre-existing adenovirus neutralizing antibodies will receive different doses of the preventive vaccine to determine its safety, tolerability, and immunogenicity.
This study will last 1 year. Participants will be randomly assigned to one of two groups. At study entry, participants in each group will receive a single injection of either one of two doses of the adenoviral vector vaccine or placebo. Participants will record their temperature and other side effects in a symptom log on the day of vaccination and for 3 days thereafter. Participants will have seven clinic visits over 12 months. A physical exam, HIV and pregnancy prevention counseling, and blood and urine collection will occur at each visit. Participants will also be asked about side effects they may be experiencing and medications they are taking.
|United States, California|
|San Francisco Vaccine and Prevention CRS|
|San Francisco, California, United States|
|United States, Tennessee|
|Vanderbilt Vaccine CRS|
|Nashville, Tennessee, United States, 37232|
|United States, Washington|
|FHCRC/UW Vaccine CRS|
|Seattle, Washington, United States, 98104|
|Study Chair:||Laurence Peiperl, MD||San Francisco Department of Public Health|