AIDSWEEKLY Plus; Monday, July 23 & 30, 2001
Staff Medical Writers

NewsRx -Researchers testing an experimental HIV vaccine have injected the first of 40 volunteers in Trinidad for a study sponsored by a U.S. health agency and the French and U.S. manufacturers.

"The inspiration to join the program came from knowing people who had been infected that motivated me to help somehow," the 28-year-old male volunteer said.

He was injected June 20, 2001, with the first shot of the combination vaccine: ALVAC manufactured by Aventis Pasteur of Lyon, France, and rg120 MN made by VaxGen of San Francisco, California. Both are synthetic vaccines that cannot give a person HIV, according to the U.S. National Institute of Allergy and Infectious Diseases, which is sponsoring the trials.

A Trinidadian government ethics committee gave its approval in November 2000, and "our Medical Ethics Committee has ensured that the researchers will give the volunteer the best medical treatment that is available worldwide," said health minister Hamza Rafeeq.

The Caribbean, with 2% HIV infection rate, has the highest incidence of AIDS after Africa. Officials estimate at least 17,000 are infected with HIV in Trinidad and Tobago, a two-island Caribbean nation of 1.3 million people.

"With over 80% of the cases of HIV and AIDS in the developing world, we have a responsibility to be part of the exercise to find a vaccine," said Courtney Bartholomew, director of the Medical Research Foundation of Trinidad and Tobago, which is conducting the trial.

He said they would choose the rest of the volunteers, who must be free of HIV and are compensated only for meals and lost job time, over the next six months.

The Trinidadian foundation is working with research centers in Brazil and Haiti, which also will carry out trials on 40 volunteers each, and U.S. universities such as the University of Baltimore, Cornell University, and the University of Pittsburgh.

First and second phase trials of a similar vaccine combination are being conducted in Thailand, the U.S. institute said.

Volunteers are screened and approved over six months, receive four sets of shots over six months, and are monitored for an additional six months. Some will receive only the ALVAC vaccine and others will receive placebos.

This is the second phase of the project, designed to test effects on the immune system. A first phase tested the safety of the vaccine among 3,000 volunteers in the United States and Europe.

A third and larger phase, cleared for approval in the United States, is to determine whether the vaccine is successful in preventing HIV. The U.S. institute said that phase would likely include volunteers at higher risk of contracting HIV.

The institute says it has enrolled volunteers for Phase I and II trials on nearly 30 different experimental vaccines since 1987.

Reported side effects of the vaccines so far have been limited to little more than tenderness at the injection site and some reports of headache and nausea, the Trinidadian foundation said.

This article was prepared by AIDS Weekly editors from staff and other reports.

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