The second phase of clinical trials of an Italian-developed HIV vaccine, to be conducted by researchers in SA as part of a wider cooperation project between Italy and South Africa, was launched in GaRankuwa north of Pretoria on Tuesday.
Funded by the Italian government, the study will be conducted by researchers and staff at the Medunsa Clinical Research Unit (MeCRU) of the University of Limpopo’s Medunsa Campus in GaRankuwa.
The HIV Vaccine Research Unit of the Walter Sisulu University in the Eastern Cape is envisaged as an additional site once development of the MeCRU site is completed.
The trial will test the HIV-1 Tat vaccine, which has come to be known as “the Italian vaccine”, a therapeutic vaccine based on the HIV-1 Tat protein developed by the Italian National Aids Center at the Italian National Institute of Health.
According to the website HIV1tat-vaccines.info, 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 trial is set to test the vaccine’s immunogenicity (whether it causes or induces an immune response) and safety in HIV-infected people already on antiretroviral (ARV) treatment and who have not developed antibodies against the HIV Tat protein.
The study involves the recruitment of 200 participants between 18 and 45 years of age, and will take place in South Africa over a period of about a year.
The trial is part of a wider cooperation project between the governments of Italy and South Africa to help support the South Africa’s Department of Health in implementing its national HIV/Aids response programme.
Speaking during the launch of the clinical trial at MecCRU, Italian Ambassador Elio Menzione said the programme aimed to reduce and control the spread of HIV in South Africa, noting that this could be achieved by giving technical assistance and development of human resources.