A promising
experimental vaccine to prevent the AIDS virus has failed in
a crucial experiment, with volunteers becoming infected with
HIV anyway, leading the drug developer to halt the
study.
Merck & Co.
said Friday that it is ending enrollment and vaccination
of volunteers participating in the international study,
which is partly funded by the National Institutes of
Health.
Officials at
Merck told the Associated Press that 24 of 741 volunteers
who got the vaccine in one segment of the trial later become
infected with HIV, the virus that causes AIDS. In a
comparison group of volunteers who got dummy shots, 21
of 762 participants also became infected with HIV.
''It's very
disappointing news,'' said Keith Gottesdiener, head of
Merck's clinical infectious disease and vaccine research
group. ''A major effort to develop a vaccine for HIV
really did not deliver on the promise.''
The study
volunteers were all free of HIV at the start of the
experiment. But they were at high risk for getting
HIV: most were homosexual men or female sex workers.
They were all repeatedly counseled about how to reduce
their risk of HIV infections, including use of condoms,
according to Merck.
In a statement,
the NIH said a data safety monitoring board, reviewing
interim results, found the vaccine cannot be shown to
prevent HIV infection or limit severity of the disease
''in those who become infected with HIV as a result of
their own behaviors that exposed them to the virus.''
The Merck vaccine
was the first major test of a new strategy to prevent
HIV infection. The first wave of attempts to develop a
vaccine tried to stimulate antibodies against the
virus, but that didn't work.
The new effort,
and one being tried in most other current research, is
aimed at making the body produce more of a crucial immune
cell called killer T-cells. The goal is to
simultaneously ''train'' those cells, like an army, to
quickly recognize and destroy the AIDS virus when it enters
cells in the bloodstream.
Merck and the HIV
Vaccine Trials Network, an international collaboration
of researchers and institutions, cosponsored the study. The
Merck vaccine was the farthest along of several in
development, and this was its first large-scale test.
The experiment,
called STEP, began in December 2004 and had enrolled
3,000 volunteers in Australia, Brazil, Canada, the Dominican
Republic, Haiti, Jamaica, Peru, Puerto Rico and the
United States. It aimed to determine if the vaccine --
a shot made from a weakened cold virus that included
bits of three HIV genes -- could prevent HIV infection, or
reduce the amount of HIV in the blood of infected people, or
both. (AP)