The Italian National AIDS Center has been conducting research for over ten years on HIV AIDS Vaccines, focusing its effort on the HIV-1 Tat vaccine candidate which uses the HIV-1 Tat protein as an antigen. The HIV-1 Tat Vaccine has become internationally known in recent years as the Italian AIDS vaccine. The use of the HIV-1 Tat protein as a candidate vaccine antigen represents a radically different approach to creating a vaccine against HIV-1 since it is based on the use of a regulatory protein produced very early after HIV infection, instead of the use of envelope proteins as most other HIV AIDS vaccines tested in the clinic to date do. The Italian AIDS vaccine has successfully been tested in pre-clinical studies, was found to be safe and immunogenic in Phase I clinical studies, and is being currently tested in a phase II therapeutic study in Italy in subjects under anti-retroviral therapy. Plans are underway to test the HIV-1 Tat protein alone in South Africa and in combination with HIV-1 Env in a phase I study in Italy. |