- WASHINGTON (Reuters) - The
U.S. National Institutes of Health said on Monday it was abandoning a
scheduled
trial that would combine two experimental AIDS vaccines in a double punch
against the virus, but said a similar trial would go ahead in
Thailand.
-
- The U.S. test had been planned to include 11,000 gay
men, drug users and others considered at high risk of HIV infection and
was meant to see if the two vaccines, one made by France's Aventis Pasteur
and one by VaxGen, would work to control the AIDS virus.
-
- Aventis and the National Institute of Allergies and
Infectious
Diseases (NIAID) said the U.S. trial was being abandoned for technical
reasons. It had been designed to see if there were ways to test someone
who had been vaccinated to see if he or she was immune to HIV to any
degree.
-
- But the NIAID said another trial of the two vaccines,
scheduled to start in Thailand, would go ahead.
-
- "It will be the world's largest phase III HIV
vaccine
trial, with 16,000 participants," Beth Waters, a spokeswoman for
Aventis,
said in a telephone interview. A phase III trial is the last stage of
testing
before a drug or vaccine goes to the U.S. Food and Drug Administration
for approval.
-
- Jim Tartaglia, vice president for research at Aventis,
said the Thailand trial would probably start in September. There,
researchers
will watch to determine if people become infected with HIV after being
vaccinated.
-
- "In the Thai trial we are looking at protection
from infection," Tartaglia said.
-
- "But there also will be assessments of viral load
so we will also be able to assess whether, even if a person becomes
infected,
if the vaccine has an effect on the infection in that individual, if it
is able to blunt it," he said. Viral load measures how much virus
is in a person's blood.
-
- More than 90 potential AIDS vaccines are in various
stages
of trials. Scientists hope a vaccine could be available within a decade
but they have dramatically lowered their sights, saying the first vaccine
may only offer partial protection.
-
- "When you think about a vaccine that does that,
it could have a really significant impact on the transmission and on the
disease course in individuals," Tartaglia said.
-
- The NIAID announced at the same time that it was taking
over responsibility for AIDS vaccine trials from the Department of
Defense.
-
- A spokeswoman for the White House Office of Management
and Budget (OMB), which ordered the move, said the change was part of
President
Bush's budget and was aimed at shifting vaccine research to the agency
that had the most expertise.
-
- She said the funds earmarked for the Defense research
would be transferred to NIAID.
-
- The Department's U.S. Army Medical Research and Materiel
Command had been poised to help sponsor the Thai trial, one of several
vaccine trials it is sponsoring.
-
- There had been criticism that the government had
competing
agencies doing the same research.
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