A small 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/II clinical trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. of an Australian-developed preventative HIV vaccine is expected to start at Sydney’s St Vincent’s Hospital early this year, subject to gaining necessary regulatory approvals.
The trial, which will enrol 24 HIV-negative volunteers assessed as being at low risk of HIV infection, is designed to measure the safety and immune response generated by the vaccine, which uses a “prime and boost” approach: an initial injection of a DNA-based vaccine is followed up with a shot of harmless fowlpox virusA small infective organism which is incapable of reproducing outside a host cell. which has been genetically modified to act as a ‘vector’ to carry HIV genesThe most basic unit of genetic information. to boost the immune response.
If the one-year trial is successful, it will pave the way for much larger phase III trials of the vaccine which are planned to take place in Thailand, where the prevalence of HIV is significantly higher.
The Australian-developed project, which is being funded by the US National Institutes of Health, is a unique collaboration between public sector, private sector and community organisations including 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. ).
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