The first human trials of an Australian-developed preventive HIV vaccine have commenced in Sydney, with volunteers being recruited.
The phase IA clinical trial designed to establish whether an experimental drug is safe for humans to take. Phase I studies determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and look for early evidence of effectiveness; these studies may include either people with HIV, HIV-negative volunteers, or both 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 enrolledThe act of signing up participants into a study. Generally this process involves evaluating a participant with respect to the eligibility criteria of the study and going through the informed consent process.. 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 virusA small infective organism which is incapable of reproducing outside a host cell. 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 preclinicalReferring to the testing of experimental drugs in the test tube or in animals – the testing that occurs before trials in humans may be carried out. 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 (AFAOAustralian Federation of AIDS Organisations. AFAO is the peak non-government organisation representing Australia's community-based response to HIV/AIDS. AFAO's work includes education, policy, advocacy and international projects. ), 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.