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September 18, 1987

HIV Vaccine Approved for Clinical Trials

JAMA. 1987;258(11):1433-1434. doi:10.1001/jama.1987.03400110013003

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THE FIRST CLINICAL TRIALS in the United States of a vaccine against human immunodeficiency virus (HIV) are slated to begin this month.

The Food and Drug Administration (FDA) approved the vaccine, registered as VaxSyn HIV-1 by the manufacturer, MicroGeneSys, Inc, West Haven, Conn, for investigational use Aug 18. It is one of several HIV vaccines in various stages of development in this country. At least three other efforts—by Genentech, San Francisco; two Seattle-based firms, Genetic Systems and a Bristol-Myers subsidiary, Oncogen; and the Institute of Immunological Disorders, Houston—may see vaccines reach clinical trials by year's end.

VaxSyn HIV-1, a recombinant form of the HIV envelope protein gp 160, is the product of a collaboration between Micro Gene Sys (pronounced "microgenesis") and investigators at the National Institute of Allergy and Infectious Diseases (NIAID). MicroGeneSys holds the patent on the vaccine and will pay royalties to the federal government should the vaccine eventually be marketed.