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Next-generation AIDS vaccine for healthy individuals being tested for safety, tolerability at UC Davis

(SACRAMENTO, Calif.) A clinical trial testing the safety and tolerability of two investigational AIDS vaccines for healthy individuals is being launched this week at the UC Davis School of Medicine and Medical Center. The study, which is part of a multi-site clinical trial, will enroll up to 126 individuals nationwide. Ten to 20 participants will be recruited into the UC Davis study.

Known as a Phase I clinical trial, the UC Davis study will test the safety and tolerability of genetically engineered vaccines that have been designed to protect the body against HIV infection. Developed by Merck Research Laboratories, the test vaccines include a piece of HIV known as Gag. These next-generation vaccines are based on the use of DNA and a non-infectious particle known as an adenovirus. Because both vaccines are produced through genetic engineering techniques, they do not contain any live virus and cannot cause HIV infection. The HIV-1 gag DNA vaccine includes a man-made copy of one of the genes from HIV, which will make an immune response to the real HIV. The adenovirus serotype 5 HIV-1 vaccine also contains the same man-made copy of the HIV-1 gene but uses a defective, non-infectious respiratory virus (adenovirus) as a backbone. These test vaccines are designed to stimulate the immune system to develop an immune defense against the HIV proteins.

The goal of this study is to evaluate the effect of these vaccines on the immune systems ability to produce T-cell responses and antibodies against HIV-1, said Thomas Evans, professor and chief of the Division of Infectious Diseases at UC Davis School of Medicine and Medical Center and principal investigator of the study. A secondary goal is to assess whether aluminum phosphate, a common additive to vaccine formulas, improves the immune response.

The trial is a double-blind study, with some participants receiving the test vaccines and some participants receiving a placebo, an inactive substance use
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Contact: Carole Gan
cfgan@ucdavis.edu
916-734-9047
University of California, Davis - Health System
12-Oct-2001


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