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Canadian researchers have announced
that initial results from human clinical trials of an HIV vaccine showed no
adverse effects. The vaccine, which was developed by researchers at the
University of Western Ontario, is the first preventative vaccine using a
genetically modified killed whole virus. The vaccine - called SAV001-H - was
approved by the US Food and Drug Administration in 2011 to begin human clinical
trials and is the only HIV vaccine currently being developed in Canada.
The vaccine uses HIV-1 virus that
has been genetically altered so that it will not cause disease. Dr. Chil-Yong
Kang, professor of virology at the university’s Schulich School of Medicine and
Dentistry, and colleagues further inactivated the virus using chemicals and
radiation. This strategy was used before to create successful vaccines for
influenza, polio, rabies, and hepatitis A, so the researchers believed it
should work.
To test the safety and tolerability
of the virus, 24 healthy men and women with HIV were randomly divided into two
treatment groups, one receiving the vaccine and one receiving a placebo. The
participants, aged 18 to 50 years, were given monthly checkups and so far have
shown no local reactions or symptoms. The main complaint was a sore arm which
lasted about a day. After receiving the vaccine, the experimental group showed
increased levels of HIV-1 antibodies which means that the vaccine was working
to stimulate immune responses.
The second phase of clinical trials
will begin in 2013, when the researchers will test the vaccine on about 600
HIV-negative volunteers at high risk for HIV infection. This test will be
conducted by the CIHR Canadian HIV Trials Network. Phase 3 will enroll about
6,000 HIV-negative volunteers at high risk for the disease. The first test was
carried out in the United States on persons selected at two Los Angeles
hospitals. The second and third phases will be conducted in Canada, the United
States, and various European countries.
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
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