United Press International - Tuesday, 11 July 2000
Michael Smith, UPI Science News

"This is the first vaccine designed for Africa with the collaboration of African scientists," Seth Berkley, president of the vaccine initiative said at the 13th International AIDS Conference.

Berkley said the clinical trial was approved Tuesday by Britain's Medicines Control Agency and will involve 18 healthy volunteers who are not infected with HIV. A second arm of the trial, also involving 18 healthy volunteers, will take place in Kenya, once that country's officials give formal approval.

Evan Harris, the member of Parliament for Oxford West and Abington, will help test the new drug for safety, said Oxford University researcher Andrew McMichael, who developed the vaccine in collaboration with professor J. J. Bwayo of the University of Nairobi.

Although the identities of people in drug trials are usually kept confidential, McMichael said, Harris, who is a medical doctor, agreed to go public to help publicize the trial.

A spokesman for the British government, international development secretary Clare Short, said in a statement that the UK government "is pleased to be the first government to offer major support for this work."

"We hope that this trial bears fruit," Short said.

The approval of the clinical trial coincided with IAVI's announcement of a blueprint to accelerate the development of vaccines against AIDS, which killed nearly 3 million people last year. World-wide, 33.4 million people either have full-blown AIDS or are infected with HIV, according to figures released June 27 by the United Nations Joint Programme on HIV/AIDS.

IAVI called for more than $900 million in new money to find vaccines and a greater focus on developing countries. As well, the non-profit organization called for speeding up development and testing of potential vaccines.

"With 15,000 new infections a day, even a few days of delay can mean thousands of extra AIDS deaths," Berkley said.

The vaccine candidate is intended to mimic the reaction of a group of prostitutes in Kenya, who have not become HIV-positive despite repeated exposure to the virus. The women have been intensively studied for more than 15 years, initially as part of an outreach program reaching back before the AIDS epidemic, and appear to have a natural immunity to the virus.

McMichael said the Kenyan women have an unusual immune response, involving high numbers of the killer cells known as CD8 cytotoxic T-cells, but no production of antibodies. He said the vaccine is intended to induce the same response in others who lack their natural immunity.

The vaccine uses two parts of a gene from the HIV-1 A strain, which infects most of the HIV-positive people in Kenya and east Africa, McMichael said. (Similar trials in Africa use the B strain, which is predominant in North America, said Wayne Koff, IAVI's vice-president.)

The first part of the vaccine strategy involves injecting the DNA from the HIV gene, he said. Then researchers will follow up with a smallpox virus engineered so that it can't cause smallpox, but modified to carry the HIV gene fragments.

McMichael said if the vaccine works, it probably will not be permanent, but will have to be repeated from time to time. But he said he was unable to say how long the vaccine might work.

Bwayo said he doesn't expect any problem getting approval from the Kenyan government. "Everybody is aware of the urgency of the problem," he added.

Kenya has 2.1 million people infected with HIV or with full-blown AIDS, about 14 percent of the population.
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