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Highlights

LAUNCH OF THE PHASE I TRIAL OF THE SECOND GENERATION OF PREVENTIVE VACCINE AGAINST HIV INFECTION BASED ON THE ASSOCIATION OF TAT AND ENV PROTEINS OF HIV-1 IN HEALTHY ADULT VOLUNTEERS

The National Center of the Istituto Superiore di Sanità launches the first phase of clinical testing of preventive HIV vaccine (study ISS P-002) based on a vaccine that combines the Tat protein, which is already advanced to therapeutic phase II trials in Italy and South Africa, and the Env protein,supplied by Novartis as part of a collaboration in the AVIP European project .
Tat and Env proteins have already been tested individually in clinical trials in humans and both were found to be safe and well tolerated, while to date the combination of the two products has been evaluated only in animal models where it has proved to be safe, well tolerated and capable of preventing HIV infection. The new study ISS P-002, involves 3 prominent clinical centres in Italy (the Division of Infectious Diseases of the Policlinico of Modena; the Division of Infectious Diseases of the San Gerardo Hospital of Monza; the Infectious Dermatology of the IFO - San Gallicano of Rome), has been approved by the competent Regulatory Authorities and by the Ethical Committees of the clinical centres. The study will involve 50 adult subjects between 18 and 55 years of age and aims to evaluate the safety and immunogenicity of the new vaccine candidate.
Tat and Env proteins will be administered according to a prime-boost vaccine regimen, consisting of 3 priming doses given by intradermal injection, followed by 2 boosts administered intramuscularly.
All persons willing to partecipate to the trial will have to contact directly the 3 clinical sites involved, where a multi-disciplinary medical team will monitor the volunteers for the all duration of the study.
The study will be supported by three independent committees, each with a specific function:
- A Data Safety Monitoring Board (“DSMB”), formed by international experts of welldocumented experience in the field of HIV/AIDS, will monitor the safety of the volunteers by periodically evaluating all clinical and laboratory data during the trial, to ensure the safety of the participants to the study.
- An International Advisory Board (“IAB”), composed of international experts in the immunological, virological or vaccine field, will provide independent scientific and technical advices to the Sponsor.
- A Community Advisory Board (“CAB”), constituted by exponents of non-governmental organisations (ONG) active in fighting and preventing HIV/AIDS, will assist the Sponsor since the very beginning of the study in supporting and protect the interests and well being of the volunteers.

The enrolment of the volunteers will be performed at each clinical centre.

Anyone interested in learning more about the trial may call the toll free AIDS telephone number,800 861 061, from Monday to Friday between 13:00 and 18:00.

Further details on the HIV-1 Tat vaccine are also available on the website at http://www.hiv1tat-vaccines.info.

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Published 15-06-2011 in Highlights , last update 28-03-2014

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