Vanderbilt University Medical Center is recruiting healthy volunteers for the second phase of testing of a novel HIV vaccine regimen that also is being studied in AIDS-battered countries around the world.
The regimen consists of two vaccines containing synthetically modified genes from three subtypes of the AIDS-causing human immunodeficiency virus (HIV). These subtypes are responsible for about 85 percent of HIV infections worldwide.
“This is the first Phase II study of a vaccine candidate that is broadly relevant to the global AIDS pandemic,” Gary Nabel, M.D., Ph.D., director of the federal Vaccine Research Center, said in a news release. A Phase II study is designed to test whether the vaccines are safe and well tolerated, and whether they cause an immune response.
Studies in primates suggest that these vaccines may not prevent HIV infection but may modify infection so that people do not develop AIDS and are much less likely to transmit the virus to others, said Peter F. Wright, M.D., director of the Division of Pediatric Infectious Diseases, who is leading the Vanderbilt study.
The Vanderbilt researchers are seeking 26 healthy adults between the ages of 18 and 50 who are not infected with HIV. Women who are pregnant, breastfeeding or planning to become pregnant are not eligible for the study.
Participants will be divided into two groups. One group will receive four injections of the two vaccines over six months. The other, which will serve as a control group, will receive injections of placebo (sterile salt water). Study participants will be followed for six months after the last injection.
The vaccinations cannot cause HIV infection, because they are made from gene fragments, not live virus or HIV-infected cells.
In previous studies, some subjects reported mild to moderate symptoms after the injections, including pain at the injection site, fatigue, headache and superficial skin lesions, but in most cases these symptoms were short-lived.
The vaccines were developed by scientists at the Dale and Betty Bumpers Vaccine Research Center, part of the National Institute of Allergy and Infectious Diseases in Bethesda, Md. They will be tested in about 480 people from three African nations, Brazil, Haiti and Jamaica, as well as six U.S. medical centers.
For more information or to volunteer for the study, contact Joshua Barnes in the Vanderbilt HIV Vaccine Program at (615)-322-HOPE (4673) or joshua.barnes@Vanderbilt.Edu.
