An extensive HIV program conducted jointly by the National HIV/AIDS Research Center and the South African Department of Health.
The project, funded for 20 million euros by the Italian Ministry of Foreign Affairs and International Cooperation (MAECI), was conducted by the National Centre for HIV/AIDS Research (CNAIDS) in close cooperation with the Department of Health of South Africa (NDOH) and the South African Medical Research Council (SAMRC).
The program, in support of the South African Department of Health's national plan to implement a global response to HIV/AIDS, has been conducted along three lines: the Service Component, aimed at capacitating and strengthening HIV/AIDS care and clinical research in the public sector in three provinces of South Africa; the Production Component, aimed at establishing a GMP ("Good Manufacturing Practice") facility for vaccine production in South Africa; the Vaccine Component, aimed at conducting a phase II clinical trial with the Tat vaccine against HIV/AIDS developed at CNAIDS. The program, conducted in close cooperation with South African counterparts, began in 2008 and has recently ended with activities aimed at ensuring the sustainability of the results through the "Tat Vaccine Partnership", an initiative aiming to mobilize public and private resources in Italy and South Africa to complete the testing of the Tat vaccine (i.e., phase III efficacy testing). The impact of the program has been positively evaluated by the United Nation Industrial Development Organization (UNIDO), which pled for mobilization of resources toward completion of vaccine testing.
Through the program, ISS and CNAIDS have built enduring operational and collaborative links with NDOH, the provincial "Department of Health", SAMRC and local communities in the provinces of Gauteng (Health District "Tswane 1"), in Eastern Cape (Health District "OR Thambo"), in Mpumalanga (Health Districts "Ehlanzeni", "Gert Sibande" and "Nkangala") and in Kwazulu Natal (KZN) (Health District "Umzinyathi"). Program intervention in the public health sector was aimed at the provision of equipment to strengthen basic clinical care and to promote the achievement of National Core Standards, strengthening clinical and laboratory data capture and analysis, and training of human resources (both medical and paramedical staff).
Further, the implementers have established a clinical and laboratory platform for conducting clinical research in the public sector in South Africa. Through the development of the Clinical Research Units "Mecru" and Walter Sisulu University HIV Vaccine Research Unit (WSUHVRU) (now Nelson Mandela Academic Clinical Research Unit), based in the public universities "Sefako Makgatho" (Pretoria area, Gauteng) and "Walter Sisulu" (Mthatha area, Eastern Cape), the platform is able to integrate clinical research with HIV patients recruitment, care and surveillance at rural or sub-metropolitan public health clinics. The platform also integrates public diagnostic laboratories of the National Health Laboratory Service and the research laboratories of the Clinical Research Units and ISS-CNAIDS. This operational network has also interfaced with some advanced Clinical Research Units in the Johannesburg and Soweto area (HIV Clinical Research Unit and Perinatal HIV Research Unit).
Through the program, a GMP facility for the manufacturing of recombinant vaccines was established at "BIOVAC", a South African public/private biotech company in the Cape Town area. Finally, the phase II trial of the Tat vaccine was completed, followed by a follow-up study for the evaluation of the persistence of the immuno-virological effects Tat vaccination. The results of the randomized, double-blinded and placebo controlled trial with the Tat vaccine, conducted in patients on antiretroviral therapy, showed the induction of persisting anti-Tat antibodies reactive against the Tat protein from different virus strains, which was associated with a significant increase in the number of CD4+ T lymphocytes in vaccinated subjects as compared to placebo.
The results of the studies conducted in Italy and South Africa indicate that the clinical development of the Tat vaccine should be continued with efficacy studies (phase III of the trial) toward vaccine registration. These studies will test the use of the vaccine in patients who respond poorly or are not adhering to the therapy, and will to evaluate its use in the pediatric population and in patients at the first diagnosis of infection (Test&Treat).