The Search for an HIV Vaccine
In 1999 the National Institutes of Health formed the HIV Vaccine Trials Network (HVTN). The HVTN is a global network of 10 US sites and 13 international sites and its goal is to find a safe and effective vaccine to prevent HIV infection. To reach this goal, the HVTN conducts all phases of preventive HIV vaccines trials, from determining the safety of and immune response to candidate vaccines (Phase 1 and 2 trials) to determining whether vaccines actually work in preventing HIV infection (Phase 3 or efficacy trials).
The HIV Vaccine Trial Unit (HVTU) in New York City is a collaboration of two institutions, Project ACHIEVE of the New York Blood Center and Columbia University's HIV Clinical Research Unit.
Project ACHIEVE is a collection of research studies devoted to HIV prevention and is part of the Laboratory of Epidemiology at the New York Blood Center. The purpose of its research is to evaluate the safety and efficacy of ways to prevent HIV transmission and infection, with an emphasis on both preventive vaccines and risk reduction counseling. Project ACHIEVE has two offices in NYC with a long history of working with at-risk communities.
Project ACHIEVE-Union Square, located in lower Manhattan, primarily focuses on research trials with men who have sex with other men. Current studies include the Explore study, a multi-site study looking at different types of HIV prevention counseling, and the Vaxgen trial, the first preventive HIV vaccine efficacy trial in the U.S.
Project ACHIEVE's other site, located in the South Bronx, focuses on trials with women at risk for HIV infection through heterosexual contact. Ongoing studies include the Vaxgen trial, a computer-based intervention trial to increase condom use and a qualitative study to examine the relationship between violence, drug use and HIV risk.
Columbia University's HIV Clinical Research Unit, located in upper Manhattan, has been active in both AIDS Clinical Trials Group (ACTG) and industry sponsored studies, and was one of the first sites to test an integrase inhibitor for the treatment of HIV infection. The site is currently testing a therapeutic vaccine for the treatment of HIV.
Together, these sites will conduct multiple trials of a variety of candidate HIV vaccines. Currently, the sites are conducting two phase 1 trials. The first phase I trial which is open for recruitment is HVTN 041. The vaccines used in this study are a recombinant NefTat, a synthetic copy of two HIV regulatory proteins and gp120 vaccine formulated with an adjuvant, a substance used to enhance the immune stimulating properties of the vaccines. This study will be looking at the safety and immunogenicity of the candidate vaccines. Injections will given at months 0,1 and 3 of the study. The duration of the study is 12 months and will enroll 84 volunteers across 10 sites in the United States.
The second phase I trial that the NYC HVTU is conducting is HVTN 039. This study is examining the safety and immune response of the ALVAC HIV vaccine, a product previously tested in Phase I and II trials. The ALVAC-HIV vaccine is made of recombinant canarypox vector with several HIV genes inserted into the vector. This ALVAC-HIV vaccine will be given at a higher dose than previously used. Injections are given at 0,1,3 and 6 months of the study. The duration of the study is 18 months and enrollment is closed at 110 volunteers at 10 sites in the United States.
For Further Information
The NYC HVTN is looking for HIV-1 uninfected adult volunteers, men and women, at low risk of infection. Individuals in New York City can contact one of three local sites: Project ACHIEVE-Union Square at 212-388-0008; Columbia University at 212-305-6312; and Project ACHIEVE-Bronx at 718-588-8900 or 1-800-973-3312.
Michael Camacho is recruitment/retention coordinator of Project ACHIEVE.
Back to the July/August 2002 issue of Body Positive magazine.
This article was provided by Body Positive. It is a part of the publication Body Positive.