Thursday, Mar 21, 1991

New gp120 AIDS Vaccine Enters NIAID Clinical Trials

AIDS Clinical Trials Bulletin Released by National Institute of Allergy and Infectious Diseases

Baltimore and St. Louis -- March 21, 1991 --

Human clinical trials of a new AIDS vaccine will soon begin in NIAID's AIDS Vaccine Clinical Trials Network (AVCTN). The vaccine, produced in mammalian cells, is a recombinant form of gp120--a protein found on the envelope, or outer surface, of HIV. It was developed by the biotechnology firm Genentech, Inc., of South San Francisco, Calif. The trial is a Phase I, placebo-controlled, randomized study of two different dosages of the vaccine.

A total of 28 healthy HIV-negative volunteers will be enrolled in the study. First, by random assignment, 10 volunteers will receive 100 micrograms of gp120 vaccine and 4 volunteers a placebo vaccine. The vaccines will be administered by intramuscular injection at 0, 4, and 32 weeks. If the gp120 vaccine appears to induce no clinical or laboratory abnormalities, another 10 volunteers will be randomly assigned to receive 300 micrograms of gp120 vaccine and 4 volunteers a placebo vaccine at 0, 4, and 32 weeks. The study will be conducted at two sites, each of which will enroll equal numbers of volunteers receiving gp120 or placebo vaccine. Each volunteer will be followed for 52 weeks.

The study investigators will evaluate the clinical and immunologic safety of the vaccine, determine whether the vaccine induces an immune response, and compare responses to the two different doses.

Last June, Genentech reported in the journal Nature that its gp120 vaccine protected to chimpanzees from infection with HIV. The success in non-human primates prompted the company to launch the first human clinical trial of this vaccine in November 1990 at Walter Reed Army Institute of Research in Washington, D.C. Unlike the NIAID trial, that clinical trial is being conducted in a small number of healthy HIV-positive patients, and its purpose is to see if the vaccine can extend the latency period of the virus and delay the onset of symptoms.

This is the second gp120 vaccine to be tested by the AVCTN. The other gp120 vaccine, called Env 2-3 and developed by The Biocine Company, is made by a different process and produced in genetically engineered yeast.

NIAID's clinical trial of Genentech's gp120 vaccine will be carried out at two of the five AIDS Vaccine Evaluation Units in the AVCTN. Volunteers must be healthy HIV-negative men or women ages 18 to 60 who are not at high risk for acquiring HIV infection.

To obtain more information or to volunteer, contact:

Johns Hopkins University, Baltimore, MD: Carol Hilton, (301) 955-7283

St. Louis University School of Medicine, St. Louis, MO: Carol Berry, (314) 577-8649

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