There is a compelling need for a safe vaccine that is effective at 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 within the borders of these developing countries.

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 collaborates with several Sub-Saharan countries (South Africa and Swaziland ) where HIV is spreading at an alarming rate. Particularly in South Africa and Swaziland, activities are aimed at strengthening and building up the local clinical and laboratory capacity, and at involving the community in the details of the HIV/AIDS vaccine testing. These activities are conducted in anticipation of vaccine clinical trials in these countries. In addition, preparatory studies are 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 occurred through the HIV/AIDS Vaccine Division of the Perinatal HIV Research Unit at the Chris Hani Baragwanath Hospital in Soweto (Johannesburg - South Africa). Cooperation with Swaziland occurs through the Mbabane Government Hospital (Mbabane - Swaziland). Both organizations are collaborating with several bilateral and EU-funded vaccine programs, which are coordinated by ISS.

Sponsorship of the Tat vaccine clinical development

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

The National AIDS Center, recently created at ISS to further support efforts in the area of AIDS research, has established networks with national and international organizations, both public and private. These cooperative networks focus on developing new preventive and therapeutic vaccine strategies to curb the HIV-1 pandemic (see Fig. 1).

Figure 1. National AIDS Center translational Program: national and international cooperations

Among the activities which the national AIDS center is engaged in, there is the "AIDS Vaccine Integrated Project" (AVIP) (http://avip-eu.org), which is an EU-funded 5-year project. The project, coordinated by Italy's National AIDS Center, involves institutions from the public and the private sectors in Italy, Sweden, France, Germany, Finland, the United Kingdom, South Africa and Swaziland. AVIP's goal is to further the clinical development of 4 new vaccine candidates against HIV/AIDS. These will be based on a combination of HIV structural and regulatory proteins and will be tested in Phase I clinical trials in Europe. Furthermore, the National AIDS Center coordinates the "Very Innovative AIDS Vaccine" (VIAV Project), aimed at developing a second generation Tat/Env-based vaccine, and is involved in the "Mucosal Vaccines for Poverty Related Diseases" MUVAPRED (http://www.mucosalimmunity.org/muvapred/), for the development of a mucosal vaccine.

The candidate vaccines will also be subjected to epidemiological, immunological, virological and feasibility studies in South Africa and Swaziland, in anticipation of future advanced clinical testing in those countries. The National AIDS Center is also conducting similar studies in Italy/South Africa bilateral projects with support of the Ministry of Foreign Affairs and in projects from the Italian National AIDS Program.

ICAV

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

ICAV's overall strategy is to generate new vaccine approaches that are evaluated in pre-clinical studies first in mice and then validated in the monkey model upon challenge with pathogenic SHIV/SIV viruses. The vaccine candidates proven to be effective in monkeys are then recommended for further development.

USA

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.

Industry Collaborations

The National AIDS Center participates in several programs where several vaccines and formulations by different participants, including industry, are being tested. These include vaccine candidates such as such Tat/Env combinations, vaccines formulated for parenteral (not by mouth) and mucosal vaccination strategies and vaccine candidates where antigens are delivered by micro/nanoparticles (ICAV program), as well as by herpesvirus vectors (ICAV program) and or by non replicating adenovirus vectors. Some of these vaccine approaches are being tested within the context of the European funded programs AVIP, MUVAPRED and VIAV.