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2002 MAR 6 - (NewsRx.com & NewsRx.net) -- GlaxoSmithKline Biologicals (GSK Biologicals) announces the start of the first trial in humans of its recombinant, adjuvanted candidate HIV vaccine - NefTat and gp 120 formulated with the proprietary adjuvant AS02.
The main objectives are to see if the candidate vaccine is safe and whether the human immune system responds to it.
The first human clinical trial of GSK Biologicals' candidate HIV vaccine will be conducted in collaboration with the HIV Vaccine Trials Network (HVTN) in the U.S., following the encouraging results from rhesus monkey efficacy studies and other clinical studies on novel adjuvants. The HVTN is sponsored by the National Institute of Allergy and Infectious Diseases, a component of the U.S. National Institutes of Health.
This Phase I safety and immunogenicity trial will start at up to 11 clinical research centers in the U.S. Healthy male and female adult volunteers who are HIV seronegative and who are at low risk of HIV infection will be enrolled in this clinical trial. The HVTN will begin volunteer recruitment for the trial early 2002.
In earlier ...
Source: HighBeam Research, GlaxoSmithKline Biologicals announces start of human trial of novel...