Improving the Effect of HIV Drugs by Use of the Tat Vaccine - Seite 2

This study confirms the results of a previous phase II trial with the Tat vaccine conducted in Italy on 155 patients treated with antiretrovirals (Ensoli F. et al, Retrovirology, 2015 - https://retrovirology.biomedcentral.com/articles/10.1186/s12977-015-0151-y), showing induction of antibodies against Tat and restoration of CD4⁺ T cells. After three years from vaccination, the Italian study also showed a significant decrease of the "virus reservoir" in blood, a pool of "silent" virus, insensitive to antiretroviral drugs, and responsible for virus rebound upon therapy interruption or low "adherence" to treatment. A follow-up study is ongoing also in South Africa to confirm the decrease of the HIV reservoir seen in the Italian trial.

The trial in South Africa is part of a large cooperation program with the South African Department of Health and the Medical Research Council in the fight against HIV/AIDS, signed by the Governments of Italy and South Africa, and directed by Dr. B. Ensoli (Principal Investigator) and by Dr. P. Monini (head of operations in South Africa) in close collaboration with the South African counterparts. The program was funded by the Italian Ministry of Foreign Affairs and was audited with recommendations for future sustainability of its achievements by the United Nations Industrial Development Organization (UNIDO)(https://open.unido.org/index.html#/projects/ZA/projects/100086).

Prof. Gualtiero Ricciardi, the new ISS President, underlines that "the Program represents an example of excellence that has effectively combined the translational clinical research with public health, and promoted innovation and international development."

The Italian and South African counterparts are now advocating moving to phase III studies toward vaccine registration with financial support from international organizations.

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The Istituto Superiore di Sanità  

The Istituto Superiore di Sanità (National Institute of Health), also ISS, is an Italian public institution that, as the leading technical-scientific body of the Italian National Health Service (Servizio Sanitario Nazionale), performs research, trials, control, counseling, documentation and training for public health. The Institute is under the supervision of the Ministero della Salute (Ministry of Health). Home for some time to three Nobel price winners who conducted research within its walls, (Daniel Bovet, Ernst Boris Chain, Rita Levi Montalcini), ISS today is a body of approx. 2.000 scientists, technicians and office personnel in the heart of Rome's biomedical research and hospital area.