The following news story is
from Reuters News Service
Experimental
AIDS vaccine safe for babies-US study
Last Updated: 2003-02-12
12:28:24 -0400 (Reuters Health)
By Maggie Fox
WASHINGTON (Reuters) - An experimental AIDS
vaccine seems to be safe for babies born to women infected with HIV, and early
signs suggest it may help protect them from infection, US researchers said on
Wednesday.
The vaccine, made by Aventis Pasteur, is one of dozens
being tested, although few experts believe any of them could actually prevent
HIV infection in a global population.
Instead, doctors are hoping to use different vaccines on
different groups in the hope of preventing some infections.
One of these areas is in mother-to-child transmission of
the AIDS virus. About a quarter of children born to HIV-infected mothers catch
the virus, either during birth or through breast milk.
Giving the mother and baby drugs can reduce this risk, but
a vaccine might be safer, more effective and perhaps cheaper.
A network of doctors across the United States, led by Dr.
Elizabeth MacFarland of the University of Colorado Health Sciences Center,
tested Aventis Pasteur's experimental ALVAC-HIV vCP205--which is a vaccine using
canarypox, a distant relative of the virus used in the smallpox
vaccine--combined with several proteins from the AIDS virus.
The idea is to prime cells to recognize and destroy cells
infected with HIV.
They tested 23 babies with four doses of the vaccine. All
were born to HIV-infected mothers in the United States.
It was a phase I-II study designed to show that the
vaccine was safe, not to prove it works, said Aventis Pasteur's Jim Tartaglia.
"It wasn't designed as an efficacy trial. You would have
to do a whole new trial to show that," Tartaglia, head of research for the
company, said in a telephone interview.
The study showed the vaccine was safe, with no serious
side-effects in the babies, the researchers told the 10th annual Conference on
Retroviruses and Opportunistic Infections in Boston, the major annual scientific
meeting on AIDS.
Tartaglia said it often takes a long time, sometimes
years, to determine whether a baby has contracted the AIDS virus. The babies
were not tested to see if they contracted HIV but the vaccine did cause an
immune response in the babies, which would suggest it may help to prevent HIV
infection.
DISCUSSIONS IN AFRICA?
Tartaglia said Aventis Pasteur is now deciding what to do
next. He said the company would discuss this with authorities in Africa--the
region hardest-hit by HIV--and the National Institutes of Health in the United
States.
A separate team of researchers tested a slightly different
version of the vaccine in HIV-infected adults who had been keeping the virus
controlled using drugs.
A strong cocktail of medicines known as highly active
antiretroviral therapy or HAART can keep AIDS at bay and keep patients healthy,
but the drugs are expensive and have unpleasant side-effects.
And the virus can eventually mutate to resist the drugs,
forcing doctors to re-formulate the cocktail.
Many researchers are testing the idea of a "drug holiday"
to give patients a break and the give the body a chance to fight the virus on
its own.
A team of French researchers told the conference they
tested 48 patients on HAART with four doses of the vaccine. Four months after
starting, they were taken off HAART.
Again, the study was meant to determine if the approach
was safe and the researchers noted no severe reactions to the vaccine.
After 44 weeks, 21% of the patients still have the virus
well under control and have not needed to re-start the drugs, they said.
Tartaglia stressed it is too soon to tell whether the
vaccine can be used to relieve patients on HAART.
"Is it a six-month drug holiday? Is it a 12-month drug
holiday? I think we are in the early stages of the field," he said.
Based in Lyon, France, Aventis Pasteur is owned by French
drugmaker Aventis SA.
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