Medicines Control Council Begins Phase I Clinical Trial of South Africa's First AIDS Vaccine

NEW YORK - The AIDS Vaccine Advocacy Coalition (AVAC) yesterday applauded South Africa's Medicines Control Council for giving the go-ahead to a long-awaited Phase I clinical trial of the countrys first AIDS vaccine.

South African regulatory approval of the small safety study of the vaccine, made public today, clears the way for testing of the first HIV vaccine tailor-made to combat the particular strain of AIDS virus circulating in South Africa, which has 4.5 million people living with HIV, more than any other country.

Besides South Africa, the clade C strain of the virus is also found in Botswana, Zambia, Zimbabwe, Mozambique, Malawi and the southern part of Tanzania. If successful, a vaccine for that region could have an enormous impact on the AIDS pandemic.

"This is wonderful news," said Huntly Collins, AVAC's director of science communication and advocacy. "Though it will be years before we know whether the vaccine actually works, it is one of the more promising scientific approaches."

The vaccine is the first anywhere made with C clade virus. Most experimental AIDS vaccines have been made with the strain of HIV circulating in the United States rather than in developing countries, where the majority of HIV infections are occurring.

The product, manufactured by AlphaVax Inc., of Durham, N.C., uses virus-like particles to deliver HIV genetic material to human cells. It was jointly developed by South African scientists and researchers at the University of North Carolina.

It is to be tested among 96 uninfected volunteers, half in South Africa and half in the United States. The joint trial will begin first in the U.S., probably in July, and then start in Johannesburg and Durban, South Africa.

The U.S. testing sites are at Johns Hopkins University, Columbia University, the University of Rochester and Vanderbilt University. The principal investigator of the trial in the U.S. is Dr. Donald Burke at Hopkins. The principal investigator in South Africa is Dr. Glenda Gray at Chris Hani Baragwanath Hospital in Soweto, just outside Johannesburg.

The vaccine is aimed at stimulating infection-fighting white blood cells to combat HIV. Though it may not provide sterilizing immunity, it could keep HIV in check so that infected people don't become ill.

The viral particles that will be used as vectors to deliver the vaccine are made from Venezuelan equine encephalitis virus (VEE), which infects horses. It has been disabled so it can't cause disease in humans.

Two other HIV vaccine candidates, one made by Merck & Co. and another sponsored by the International AIDS Vaccine Initiative, are awaiting approval by South Africas Medicines Control Council. Neither of those vaccines is made with Clade C virus.

A Phase I trial of the AlphaVax vaccine was approved by the U.S. Food and Administration on April 30. The product has been awaiting final approval by South Africa before moving ahead into human testing.

AVAC encouraged South Africas Medicines Control Council to accelerate its approval process for the two other vaccines in the pipeline.

"As the country suffering the most from HIV, South Africa needs to move as swiftly as possible to test all HIV vaccine candidates that have scientific merit and have proven safe in preliminary animal tests," Collins said.

AVAC is a private, non-profit organization that provides objective analysis of AIDS vaccine candidates and works to accelerate the ethical testing and global access to AIDS vaccines. It is funded by the Bill & Melinda Gates Foundation, Ford Foundation, International AIDS Vaccine Initiative, Until There's a Cure Foundation, Broadway Cares/Equity Fights AIDS, Gill Foundation and AVAC Members. AVAC accepts no government or industry funds.