US Drops AIDS Vaccine Test -
Thai Test Is On

By Maggie Fox
Health and Science Correspondent

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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