Novel HIV vaccine trials

GSK Biologicals has started clinical trials 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 trial will be conducted in collaboration with the HIV Vaccine Trials Network (HVTN) in the US, following the encouraging results from rhesus monkey efficacy studies and other clinical studies on novel adjuvants.

'The HVTN welcomes the opportunity to collaborate on this trial,' said Dr Larry Corey, principal investigator for HVTN. 'The testing of multiple vaccine candidates is critical to speeding progress toward an HIV vaccine and controlling the global pandemic.'

This phase I safety and immunogenicity trial will start at up to 11 clinical research centres in the US. Healthy male and female adult volunteers who are HIV seronegative and who are at low risk of HIV infection will be enrolled. The HVTN will begin volunteer recruitment for the trial early 2002.

'GSK Biologicals is committed to developing an HIV vaccine that will prevent AIDS and reduce transmission of HIV both in the developed and the developing world', said Jean Stephenne, president and general manager GSK Biologicals. 'Consequently, we will be developing our vaccine candidate against at least two of the most prevalent strains of HIV as well as studying the effect of these vaccines across different clades of the virus.'