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New
Vaccine Trial in New York Area Seeks Healthy Volunteers
The Aaron Diamond
AIDS Research Center (ADARC), an affiliate of The Rockefeller University,
and the International AIDS Vaccine Initiative (IAVI) have begun
recruiting volunteers for a human clinical trial of a new
investigational vaccine to prevent HIV infection and
AIDS.
The trial, which is expected to begin
January 2005, seeks healthy volunteers aged 18-40 in New York City
and Rochester, New York.
This
phase I research study will last 18 months and is designed to evaluate
the safety and immune system effects of a vaccine candidate called
ADMVA.
Developed
by scientists at ADARC, the vaccine candidate is based on Modified
Vaccinia Ankara (MVA), a vaccine that was used as part of a global
smallpox eradication program in the 1970s. The ADMVA vaccine candidate
is designed to stimulate immune responses to prevent people who
are not infected with HIV/AIDS from contracting the disease.
If
ADMVA performs well in initial tests, it can advance to larger trials
in other regions. ADMVA is modeled after 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 worldwide. A successful
vaccine would potentially save millions of lives each year. If
ADMVA proves effective, ADARC and IAVI are committed to ensuring
that it is made available in developing countries at affordable
prices.
“With
each passing year, the grip of the disease tightens worldwide as
the disease makes new inroads into heavily populated regions in
Asia,” said Dr. David Ho, Director and CEO of ADARC and Rockefeller
University’s Irene Diamond Professor. “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.”
“A preventive vaccine offers the best
hope for controlling the epidemic,” said Dr. Seth Berkley, President
and CEO of IAVI. “We are hopeful that ADMVA will bring us closer
to an effective vaccine.”
According to UNAIDS, approximately
13,000 people are infected with HIV worldwide each day.
“Scientific
progress to develop an effective AIDS vaccine cannot be achieved
without the participation of volunteers in vaccine trials,” said
Mitchell Warren, the Executive Director of The AIDS Vaccine Advocacy
Coalition (AVAC). “By volunteering, participants are making a vital
contribution to the vaccine development process.”
Regulatory
clearance to conduct the trial was granted by the Food and Drug
Administration on December 20, 2004. The ADMVA vaccine candidate
does not contain any material from live HIV, blood or blood products,
or materials from individuals who are infected with HIV. It is
not possible to get HIV infection from ADMVA.
The trial will
enroll approximately 48 healthy male and female volunteers ages
18-40 over the coming months. Study participants 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 will be randomly assigned to receive either the vaccine
candidate or an inactive solution known as a placebo.
Volunteers
will visit the outpatient clinics (in either The Rockefeller University
Hospital in New York City or the University of Rochester Medical
Center in Rochester, New York) 12 times over 18 months.
01/05/05
Source
Aaron
Diamond AIDS Research Center
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