Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
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The Wall Street Journal - Tuesday, February 9, 1999
Michael Waldholz and Ralph T. King Jr. Staff Reporters of The Wall Street Journal
Officials at Pasteur Merieux Connaught, the vaccine unit of the French drug maker, Rhone-Poulenc Group, said it initiated Monday a small, 40-person test of the company's Alvac-HIV vaccine at a research hospital in Kampala, Uganda. The study, begun by inoculating two healthy volunteers, is designed simply to determine if Alvac-HIV is safe, can be tolerated by an African population, and can generate a measurable response in white blood cells that make up the immune system.
Separately VaxGen Inc., a closely held biotechnology concern based in South San Francisco, Calif., said it won approval from government officials in Thailand to launch the first large-scale trial of an AIDS vaccine outside the U.S. The vaccine is designed to protect against two HIV strains most prevalent in Thailand and will be given to 2,500 intravenous drug users in Bangkok who are healthy yet whose risk of infection is high.
VaxGen -- whose president is renowned virologist Donald Francis -- began a U.S. trial of 5,000 volunteers of a similarly engineered vaccine last June, making it the first vaccine to enter the final efficacy phase of human testing. That trial, with about one-quarter of participants enrolled, seeks to halt sexual transmission of HIV among gay and bisexual males.
Pasteur Merieux Connaught has conducted similar so-called phase-one safety tests in about 800 healthy volunteers in the U.S. and France. In an interview Monday, Michel Klein, the vaccine maker's vice president for science and technology, said results from those tests indicate the vaccine is safe. In addition, in those studies, analysis of the test subjects' blood found that the vaccine generated an anti-HIV response by the immune system in about 70% of those tested after receiving four injections over six months. The response lasted about two years in 80% of those whose immune system was activated by the vaccine, Dr. Klein said.
The Africa trial is a cooperative effort by the Ugandan government and several top researchers there; Rhone Poulenc, which is providing the vaccine; and the U.S. government's National Institute of Allergy and Infectious Diseases.
The Alvac-HIV vaccine is produced by inserting proteins from HIV into a canary pox vaccine, which isn't harmful to humans. If the vaccine is safe and ignites an immune response, Dr. Klein said, his company might start larger effectiveness trials next year in Uganda.
About 1.8 million of Uganda's 20 million people are infected by HIV, though the government there has been very aggressive in recent years in fighting the disease through education and other preventive efforts. Meanwhile, VaxGen's Thai trial aims at testing its vaccine to prevent blood-borne HIV infection transmitted through the use of shared or dirty drug needles.
Thailand has been ravaged by AIDS, yet its infection rate -- less than 1.5% of its 60 million inhabitants -- is well below that of some African countries, in part because of the Thai government's aggressive prevention programs among drug users, sex workers, and other at-risk groups. Trial participants, drawn from 17 methadone clinics, will be taught techniques for cleaning needles and taught that vaccination does not necessarily confer immunity.
VaxGen's collaborators include local health officials, experts at the Mahidol University Faculty of Tropical Medicine in Bangkok, and the Atlanta-based Centers for Disease Control and Prevention, which will conduct attitude surveys of participants and community members during the three-year trial.
Some leading scientists have criticized VaxGen and its president, Dr. Francis, for testing the vaccine because it creates antibodies rather than immune-system cells that destroy the virus.
Skeptics insist that immunity requires an attack-force of killer T-cells, which is the approach taken by Pasteur Merieux and others. Dr. Francis has argued that even partially effective vaccines will save lives even as more potent vaccines are developed. VaxGen plans to begin development of a vaccine aimed at African populations later this year, a company spokeswoman said.
Dr. Francis said VaxGen will get its first interim look at data from both trials in mid-2001. If there is evidence of at least 50% effectiveness at that point, then the vaccines, or some combination of them, could be used to "drive the epidemic into the ground," he predicted.
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