Important note: Information in this article was accurate in 1987. The state of the art may have changed since the publication date.
Food and Drug Administration, U.S. Department of Health and Human Services - November 25, 1987
Susan Cruzan - (301) 443-3285
This is the second experimental vaccine approved for human testing. The first, an insect cell culture-derived vaccine made by MicroGeneSys Inc. of West Haven, Conn., was approved for human trials on Aug. l8.
This Bristol-Myers experimental vaccine is made from vaccinia virus -- the virus from which smallpox vaccine has been manufactured -- into which the genes for the surface, or envelope, proteins from the HIV virus have been inserted by recombinant DNA techniques. Researchers believe that the proteins, though not in themselves infectious, will stimulate the body to produce antibodies that may be protective against HIV infection.
Studies of the new vaccine will be carried out at the Pacific Medical Center under the direction of Lawrence Corey, M.D., director of the virology division at the University of Washington School of Medicine.
The vaccine will be tested in 30 to 60 healthy homosexual volunteers who are not infected with the AIDS virus. A control group of similar volunteers will receive regular smallpox vaccine.
FDA Commissioner Frank E. Young, M.D., Ph.D., called the vaccine "a major step in recombinant vaccine development," but he emphasized that the vaccine is in the earliest phase of clinical testing and that many questions about its safety and effectiveness must be resolved.
"Even the most optimistic experts predict that an AIDS vaccine will not be in general use until well into the l990s," Dr. Young said. "But I remain hopeful for the future because of the highly sophisticated research techniques -- especially recombinant technology -- and the vast resources being applied by both government and private sector organizations toward the search for a successful vaccine."
The study approved today is designed to assess the safety of this vaccine and its ability to induce production of antibodies. Vaccinia virus is transmitted occasionally from people vaccinated against smallpox to intimate contacts. This problem did not seriously limit its use against smallpox. Because of this potential transmission, however, the initial volunteers will be kept in isolation and their shedding of the virus will be carefully assessed. This extra layer of safety precautions should enable scientists to determine whether there are any potential problems with the use of vaccinia virus vaccine containing genes derived from the AIDS virus.
More than 40,000 persons in the United States have been diagnosed with AIDS since l981, and nearly 60 percent of them have died. Scientists estimate that over 1 million Americans are infected with the virus. A drug approved by FDA in March l987, zidovudine or AZT, extends the life of some patients with AIDS, but there is no cure at present.
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SOURCE: Food and Drug Administration (FDA).
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