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FDA approves St. Jude safety trial for second part of three-part HIV vaccine.
2003 AUG 6 - (NewsRx.com & NewsRx.net) -- St. Jude Children's Research Hospital has received approval from the U.S. Food and Drug Administration (FDA) to begin testing another part of its HIV vaccine regimen.
The hospital will now begin Phase I clinical trials for the second part of a three-tiered HIV vaccine designed to protect against diverse forms of the AIDS virus.
One of the vaccine components was previously approved by the FDA and is currently in safety trials at St. Jude. The final component has recently been submitted for FDA approval. "We expect to begin recruiting volunteers for the Phase I safety trial of the new vaccine component this summer," said Karen Slobod, MD, an associate member of the St. Jude department of infectious diseases.
Each component is being tested in independent safety trials before the three separate vaccine elements will be combined in a sequential series of inoculations. "Once all three components complete Phase I safety testing individually, they will be combined in a prime-boost-boost regimen for efficacy testing in a larger group of volunteers," Slobod said. Slobod and Julia Hurwitz, PhD, of the St. Jude immunology department, are the leaders of the vaccine project.
The St. Jude HIV vaccine is designed to overcome the problem of viral ...
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