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WASHINGTON — A new AIDS vaccine candidate that has been shown to work in one chimpanzee was approved Tuesday for early human clinical tests, the Food and Drug Administration announced.
The candidate vaccine was developed through the cooperation of the National Institute for Allergy and Infectious Diseases, the National Cancer Institute and Immuno-U.S. Inc., a Rochester, Mich. branch of an Austrian company.
At a news conference Tuesday, company officials said the clinical trials will test the safety of the vaccine and determine if the 60 test subjects develop antibodies against human immunodeficiency virus (HIV), the virus that causes AIDS. This first step of human testing, called Phase I trials, will not use AIDS patients.
If the vaccine proves to be safe and shows promise, then Phase II trials will more thoroughly test for protection against AIDS.
Dr. Martha Eibl, director of AIDS vaccine research at Immuno AG, the parent company of Immuno-U.S., said that two forms of the vaccine were tested on four chimpanzees.
The chimps were injected with the candidate vaccine and then injected with the AIDS virus, using a dose that is 100 times the amount needed to cause an infection in the laboratory.
All four of the chimps developed some immune response, and one of the animals remained free of AIDS.
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