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NIAID
Begins Enrolling Volunteers for Novel HIV Vaccine Study
A
large clinical trial of a novel HIV
vaccine has begun enrolling volunteers at sites in
North America, South America, the Caribbean and Australia. Organizers
are seeking 1,500 participants.
The
trial is co-funded by the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health (NIH),
and the pharmaceutical company Merck & Co. Inc. Merck developed
the experimental vaccine to stimulate HIV-specific cellular immunity,
which prompts the body to produce T cells that kill HIV-infected
cells. In previous smaller trials, this vaccine was found to be
safe and to induce cellular immune responses against HIV in more
than half of volunteers.
"This
new study is the first time we have used such a large sample of
people to test whether a vaccine that stimulates cellular immunity
alone either blocks HIV infection, decreases the level of HIV early
in infection or both," says Anthony S. Fauci, M.D., director
of NIAID.
This
proof-of-concept trial is designed to yield vital information on
the potential efficacy of cellular immunity against HIV, although
it is not expected to provide enough data to support immediate licensing
of the vaccine for public use, says Margaret (Peggy) Johnston, Ph.D., who oversees HIV
vaccine research at NIAID's Division of AIDS.
The
Merck vaccine contains a weakened adenovirus that serves as a carrier
for three subtype B HIV genes.
Subtype B is the most prevalent HIV subtype in the regions of the
study sites. Adenoviruses are among the main causes of upper respiratory
tract ailments such as the common cold. Because the vaccine contains
only three HIV genes housed in a weakened adenovirus, study participants
cannot become infected with HIV or get a respiratory infection from
the vaccine.
"If
this study finds that the vaccine can prevent or control infection,
we will work with Merck to evaluate the vaccine in a larger number
of volunteers," adds Dr. Johnston. "We will also work
with the company to determine the best vaccine design to test in
parts of the world where other subtypes of HIV are circulating."
The
study will be conducted jointly by NIAID's multicenter HIV Vaccine
Trials Network (HVTN) and by Merck. The lead researchers are
Michael Robertson, M.D., of Merck and two HVTN investigators: Susan
Buchbinder, M.D., of the San Francisco Department of Public Health
and Daniel Fitzgerald, M.D., of Cornell University.
The
organizers are seeking healthy, HIV-negative men and women volunteers
between the ages of 18 and 45 who are at an increased risk of acquiring
HIV. The researchers plan to enroll a significant number of volunteers
from populations particularly hard-hit by AIDS, including African
Americans and other ethnic minorities.
The
trials will take place in the following locations:
North America: Atlanta, Boston, Chicago, Denver, Houston, Los Angeles,
Miami, New York, Philadelphia, St. Louis, San Francisco, Seattle,
Toronto
South America: Iquitos and Lima, Peru
Caribbean:
Santo Domingo, Dominican Republic; Port-au-Prince, Haiti; San Juan,
Puerto Rico
Australia:
Sydney
Organizers
expect that it will take approximately one year to fully enroll
volunteers into the study. NIAID and Merck expect the trial be completed
in four-and-a-half years, with results anticipated in 2010. For
more information on enrolling, visit HVTN's Web site at www.hvtn.org.
NIAID
is a component of the National Institutes of Health, an agency of
the U.S. Department of Health and Human Services. NIAID supports
basic and applied research to prevent, diagnose and treat infectious
diseases such as HIV/AIDS and other sexually transmitted infections,
influenza, tuberculosis, malaria and illness from potential agents
of bioterrorism. NIAID also supports research on transplantation
and immune-related illnesses, including autoimmune disorders, asthma
and allergies.
01/26/05
Source
NIAID
News
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