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New AIDS vaccine trial launches
Rockefeller researchers begin testing the ‘boost’ phase of their ‘prime and boost’ strategy
BY LYNN LOVE
The second arm of a clinical study to
investigate an experimental HIV/AIDS vaccine began at the
Rockefeller University Hospital in January, when two volunteers
were injected with the ADMVA vaccine. Nine additional volunteers
have joined the study to date and a total of 48 healthy men and
women will eventually be enrolled in the protocol.
The phase I research study, which is being
administered by Rockefeller research associate professor Sarah Schlesinger, is
designed to evaluate the safety and immune system effects of a new
vaccine called ADMVA. Developed by scientists at the Aaron Diamond
AIDS Research Center (ADARC), headed by Irene Diamond Professor David Ho, the vaccine is
a version of Modified Vaccinia Ankara (MVA), a vaccine that was used as part of a global
smallpox eradication program in the 1970s. The ADMVA vaccine is
designed to stimulate immune responses to prevent people who are
uninfected with HIV/AIDS from contracting the disease. It is based
on the ‘C’ strain of HIV, which is prevalent in China,
India and Sub-Saharan Africa and accounts for more than 50 percent
of new HIV infections.
ADMVA represents the second part of
what’s known as a “prime and boost” vaccine
strategy designed to first prime the body’s immune system by
showing it synthetic, noninfectious parts of the HIV virus’s
genetic make-up, followed by boosting its ability to stave off HIV.
The first arm of the study began in December 2003, when the
Rockefeller University Hospital and ADARC began testing the first
part of the vaccine strategy, called ADVAX, in a phase I research
study. That study is ongoing for another 6 to 12 months.
Participants in the new study, which are being
recruited in New York City and at the University of Rochester
Medical Center, must be healthy, HIV-negative, and at low risk of
HIV infection. In addition, volunteers must plan not to become
pregnant or impregnate a partner during the trial and for four
months after the last vaccination. Participants are randomly
assigned to receive either the experimental vaccine or placebo. The
volunteers then visit the outpatient clinics 12 times over 18
months for follow-up blood work.
This smallpox vaccine on which ADMVA is based
was well tolerated by animals when tested, and similar HIV vaccines
made from MVA have also been well tolerated in people who received
them. The ADMVA vaccine does not contain any material from live
HIV, blood or blood products, or materials from individuals who are
infected with HIV.
“It is absolutely not possible to get
HIV infection from the ADMVA vaccine,” says Schlesinger.
A successful vaccine would potentially save
millions of lives each year. “With each passing year, the
grip of the disease tightens worldwide as the disease makes new
inroads into heavily populated regions in Asia,” says Ho.
“Developing an effective AIDS vaccine is one of the greatest
challenges researchers and volunteers have ever faced. But the
rewards in terms of lives that could be saved by an effective
vaccine are also among the greatest in human history.”
If ADMVA proves effective, ADARC and one of
the study’s funders, the International AIDS Vaccine
Initiative (IAVI), are committed to ensuring that it is made
available in developing countries at affordable prices.
EDITORIAL: New York City rises, again
March 18, 2005
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