Clinical Trials Begin In Healthy Individuals At UC Davis.(Brief Article)

2001 NOV 7 - (NewsRx.com & NewsRx.net) -- A clinical trial testing the safety and tolerability of two investigational AIDS vaccines for healthy individuals is being launched at the University of California Davis School of Medicine and Medical Center.

The study, which is part of a multisite clinical trial, will enroll up to 126 individuals nationwide. Ten to 20 participants will be recruited into the UC Davis study.

This double-blind 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 noninfectious 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, noninfectious 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 system's 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, ...