News
11/25/1987

<TITLE>AIDS Vaccine</TITLE>
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AIDS Vaccine


P87-33                                      Food and Drug Administration
FOR IMMEDIATE RELEASE                       Susan Cruzan - (301) 443-3285 

    The Food and Drug Administration announced today that Bristol-Myers 
Company of New York, N.Y., will begin tests in human volunteers of a
biotech-produced experimental vaccine to prevent infections with the virus
that causes AIDS -- Human Immunodeficiency Virus (HIV). 
    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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