The phase I trial, which is examining whether the vaccine is safe to take and successful in generating an immune response, will commence once the 24 HIV-negative participants, who must be assessed as being of low risk of HIV infection, have been enrolled. The trial will take place at Sydney’s St Vincent’s Hospital.
The vaccine is based on a ‘prime-boost’ technology, delivered in two stages: a first injection of a DNA vaccine which primes the immune system to recognise HIV, and a second vaccine based on the fowlpox virus that triggers the body’s immune response. The trial consortium says this is the first HIV vaccine to use this “double whammy” approach.
“In our preclinical testing in the laboratory we have been able to show that the vaccine is able to induce high levels of immune cells which can kill HIV, and [has] a very good safety profile,” said Associate Professor Stephen Kent of the University of Melbourne, one of the seven Australian and Thai institutions that make up the consortium which is testing the vaccine.
Don Baxter, Executive Director of the Australian Federation of AIDS Organisations (AFAO), another member of the consortium, stressed the importance of not ensuring that expectations are not raised inappropriately by the trial. He also noted that the consortium was the first of its kind in the world to include community representatives.
The results of the trial are expected by the end of the year. If successful, further studies will commence in Thailand in 2004.
