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The following news story is from Reuters News Service Logo: Reuters Health Information

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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