United Press International; Tuesday, 18 August 1987.

The vaccine, developed by MicroGeneSys, a small West Haven, Conn., biopharmaceutical firm, will be tested under supervision of the National Institute of Allergy and Infectious Disease.

The Food and Drug Administration had given formal approval to test the vaccine in small numbers of humans, but the announcement is not expected until later this week, according to the Washington Drug Letter, a weekly publication monitoring regulatory and legislative issues pertaining to the drug industry.

The vaccine is made of proteins from the outer coating of the AIDS virus and therefore is not expected to cause disease. But whether it will prevent infection by the HIV, or AIDS, virus and resulting symptoms remains to be seen.

The AIDS virus comes in many variations, distinguished by the makeup of the outer coat that protects the core of genetic material that enables the virus to reproduce. Some areas that appear to remain constant, both in the coat and inside the virus, have been pinpointed and other experimental vaccines are based on these.

Company president Frank Volvovitz said in an interview earlier in the year, "Our approach is aimed at producing a synthetic replica of the entire coat protein.

"I think the point to remember is the entire coat doesn't change. There are areas in the coat that remain constant," he said. Earlier reports had indicated the company's vaccine was based on a fragment of the coat protein.

Scientists from Oncogen, a division of Bristol-Myers Co., and George Washington University, have also applied for permission to begin human testing of their own proposed AIDS vaccines. These two announced their actions, but MicroGeneSys kept its application a secret.

"We are still waiting for approval," said Allan Goldstein, professor and chairman of biochemistry at George Washington, of his team's vaccine candidate. "My immediate reaction (to the MicroGeneSys news) is that I'm happy that finally human testing is beginning in the United States. I think it's long overdue, and the faster we get started the faster we'll know" which approach works.

The first tests will be conducted to assess the vaccine's side effects. Later, larger groups of volunteers will be enlisted to try the drug. It is not certain yet how many of the volunteers will be from groups at high risk for AIDS, such as homosexuals.

Vanderbilt scientists said they expect the experimental vaccine they test to be only the first step toward a completed vaccine, which they hope will be available in the next decade.

Confirming whether the vaccine works is expected to be one of the most difficult tasks scientists have faced. It is uncertain whether the antibodies that any proposed AIDS vaccine induce in the bloodstream will neutralize the virus.

Many organizations have injected animals with their vaccines, then extracted blood and found the antibodies produced by the animals neutralized the AIDS virus in a test tube.

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