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  HIV and AIDS
    What is "AIDS"
    Routes of infection
    First symptoms
    Having AIDS
    Can AIDS be cured?
  The Need for Vaccines
    AIDS in the World
    AIDS in Africa
  HIV-1 Tat:
    Scientific Background & Rationale
    HIV-1 Tat Protein
    Pre-clinical Studies
    Clinical Studies
    International Collaborations
    1st. Gen.: Tat alone
    2nd Gen.: Tat+Microparticles
    2nd Gen.: Tat+Env
    Discovery Phase Leads

The Istituto Superiore di Sanità (ISS) is the leading technical and scientific body of the Italian National Health Service. The National AIDS Center at ISS is responsible for research in HIV/AIDS, with the main focus on vaccine development. In particular, based on the promising results from pre-clinical studies with the Tat vaccine, the ISS sponsored and successfully conducted the preventive and therapeutic Phase I clinical trials (ISS P-001, NCT00529698 and ISS T-001 NCT00505401, respectively) of the Tat vaccine. These trials represent Italy's first public, fully government-supported Phase I trials of a vaccine against HIV/AIDS. The Tat vaccine is being currently tested in a phase II therapeutic study in Italy (ISS T-002, NCT00751595). Plans are underway to test the HIV-1 Tat protein vaccine alone in South Africa and in combination with HIV-1 Env in a Phase I study in Italy. To this goal a dedicated GMP facility has been created and validated by the Italian Regulatory Agency at the University of Urbino.

National and International HIV/AIDS Vaccine networks of the National AIDS Center

To further support efforts in the area of AIDS research, in the last 10 years the National AIDS Center established networks with national and international organizations, both public and private. These cooperative networks were focused on developing new preventive and therapeutic vaccine strategies to curb the HIV (see Fig. 1).


Figure 1. National and international cooperations established by the National AIDS Center translational Program

National AIDS Center | Italian HIV 1 Tat vaccine

The National AIDS Center has been engaged in several activities funded by the EU Commission. One project, that was closed in January 2010 has been the AIDS Vaccine Integrated Project" (AVIP)(, coordinated by Italy's National AIDS Center. It has involved institutions from the public and the private sectors in Italy, Sweden, France, Germany, Finland, the United Kingdom, South Africa and Swaziland, with the aim of developing new vaccine candidates against HIV/AIDS based on a combination of structural and regulatory HIV immunogens to test in phase I trials. The National AIDS Center also coordinated another EU-funded project, the "Very Innovative AIDS Vaccine" (VIAV Project)(, aimed at developing a second generation Tat/Env-based vaccine, and participated to the "Mucosal Vaccines for Poverty Related Diseases" MUVAPRED (, for the development of a mucosal vaccine.

Further, the National AIDS Center is a partner within the Network of Excellence "European Vaccines and Microbicides Enterprise" (EUROPRISE) (, a consortium funded by the European Commission in the sixth Framework to which 39 partners from 10 European countries are participating. The EUROPRISE promotes an integrated program of research, coordinating a wide portfolio of activities encompassing the whole pipeline of vaccine and microbicide development from early discovery through to early clinical trials.

Programs with Developing Countries

There is a compelling need for a safe vaccine that is effective for preventing infection or controlling disease progression in developing countries, particularly in Africa. Because of this urgent need, advanced clinical testing of AIDS vaccines must be performed in sites, like Africa, where HIV infection is spreading at high rates.

Within this framework, the Italian National AIDS Center, through its Division of Retrovirus Infections in Developing Countries, has initiated long-term collaboration projects over the past several years. The Center is collaborating South Africa and Swaziland, two Sub-Saharan countries where HIV is spreading at an alarming rate. Activities are aimed at strengthening and building up the local clinical and laboratory capacity, and at involving the community in the specifics of the HIV/AIDS vaccine testing. These activities are preliminary to vaccine clinical trials in these countries. In addition, preparatory studies have been designed to estimate the incidence and prevalence of HIV in the populations targeted for vaccination, and to evaluate the immune cross-recognition of the vaccine antigen.

Cooperation with South Africa occurs through several projects from the Italian Ministry of Foreign Affairs and the Italian National AIDS Programme.

The project funded by the Italian Ministry of Foreign Affairs, entitled ?Program to support the Ministry of Health of South Africa in the implementation of a national program of global response to HIV & AIDS?, foresees the governance of three stakeholders, the Italian Ministry of Foreign Affairs, the ISS and the South African Department of Health. It is a three-year program organized in three components: 1) Strengthening of South African Health Services in selected sites in South Africa; 2) Strengthening of capacities and infrastructure upgrading of a public South African company for GMP (Good Manufacturing Practice) production of vaccines and 3) conduction of a phase II therapeutic trial with the Tat-based vaccine in selected South African sites.

Projects from the Italian National AIDS Program will fund activities of research of the ?Division of Retrovirus Infections in Developing Countries? in collaboration with the Medunsa Clinical Research Unit, in the region of Limpopo in South Africa, and the National Central Public Health Laboratory (NCPHL) of the Mbabane Government Hospital in Swaziland. These projects are aimed at characterizing the external proteins (Env) from HIV-1 variants that are selected early after infection, with the aim of identifying possible new effective immunogens for the development of a vaccine against HIV.


The "Italy's National AIDS Center is part of the Italy-USA agreement for joint development of a vaccine against HIV/AIDS. This agreement was signed in 1998 by the former Italian and US presidents Prodi and Clinton and was renewed in 2003 and is still ongoing.


The "The National AIDS Center has also coordinated the "Italian Concerted Action on HIV/AIDS Vaccine Development" (ICAV), a network of highly qualified Italian research groups in about 70 Italian centers with the expertise required to effectively develop an HIV vaccine program. ICAV operated within the national AIDS program with funding by Ministry of Health and was coordinated by Italy's National AIDS Center.

ICAV's overall strategy was to generate new vaccine approaches to be evaluated in pre-clinical studies conducted in mice and then validated in the monkey model upon challenge with pathogenic SHIV/SIV viruses.

Industry Collaborations

The National AIDS Center collaborated to several programs with industry participation, where the development and testing of novel vaccines and formulations were foresaw. These include vaccine candidates such as such Tat/Env combinations, vaccines formulated for parenteral (not orally) and mucosal vaccination strategies and vaccine candidates where antigens are delivered by micro/nanoparticles, as well as by herpesvirus vectors and or by non replicating adenovirus vectors. Some of these vaccine approaches were tested within the context of the European funded programs AVIP, MUVAPRED and VIAV.



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