Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: TUESDAY, March 13, 1990 TAG: 9003133465
SECTION: NATIONAL/INTERNATIONAL PAGE: A3 EDITION: EVENING
SOURCE: Associated Press
DATELINE: WASHINGTON LENGTH: Medium
The Food and Drug Administration on Monday granted permission for further testing of the vaccine developed by Dr. Jonas Salk.
The vaccine, which uses an inactivated virus, is being tested as a treatment for AIDS rather than as an agent to prevent someone from acquiring the fatal disease, which destroys the body's ability to fight infection.
Researchers are trying to find out whether the inactivated virus will cause the body to produce specific cells, called T cells, that destroy other cells infected with the human immunodeficiency virus, or HIV.
They hope that by stimulating the immune system's response to HIV, the vaccine might halt or reverse spread of the virus in newly infected people - those who have the virus but have not developed symptoms of AIDS or AIDS-related complex.
"This vaccine is for treatment" of AIDS, said Dr. Janet Woodcock, director of the FDA's division of biological investigational new drugs. "Use of this to prevent acquiring [AIDS] is a totally different question."
Work has been accelerating on developing a vaccine to prevent AIDS, but such a vaccine is at least 10 years away from being marketed.
Under the FDA-approved plan, initial testing will involve about 60 people. During a 36-week trial, researchers will test different doses of the vaccine.
The California trials, which is testing individuals who have AIDS, were approved under a state law that allows such testing strictly within California.
FDA permission was required for the sponsor, Immune Products Ltd. of San Diego, to expand the trials to testing outside California.
Two other vaccines, both genetically engineered, have been approved for human testing in HIV-infected individuals. The first, approved in August 1987, was made from an insect virus and was developed by MicroGeneSys Inc. of West Haven, Conn. The second, made from the vaccinia virus and developed by Bristol-Myers-Squibb Co. of New York, was approved for human trials in November 1987.
A genetically engineered vaccine uses pieces of the virus that are replicated and do not contain anything that could be infectious.
Unlike those two, the Salk vaccine uses an inactivated virus that has been partially stripped of its envelope or surface proteins. Salk used a similar technique in developing the polio vaccine.
Using an inactivated virus in an uninfected person carries the risk that some traces of the virus may still be live and could infect the person being vaccinated.
by CNB