The Italian Concerted Action on HIV/AIDS Vaccine Development (ICAV) has been established under the National AIDS Programme coordinated by the National AIDS Centre and consists of a network of approximately 70 Italian centres. The activities of the ICAV programme are described in Table 12.
Through these and the other networks in which ISS participates, several vaccines and formulations by different participants are in the pipeline. These novel vaccine candidates also include second-generation Tat-based vaccines such as the Tat/ΔV2Env combination [AVIP, Mucosal vaccines for poverty-related diseases (MUVAPRED), very innovative AIDS vaccine (VIAV) and ISS/Novartis–Chiron agreement] and Tat alone or in combination with other HIV products delivered by micro/nanoparticles (ICAV) as well as herpesvirus vectors (ICAV) and replication-competent adenovirus vectors (Italy–USA, ISS/National Cancer Institute–National Institutes of Health) for parenteral and mucosal vaccination strategies.
The establishment of national and international networks, including private companies, public and academic institutions, is essential for vaccine development and should always include training programmes such as the AVIP International School (www.avip-eu.com), which is proving to be an optimal forum to train students, scientists and clinicians in the difficult aspects of HIV/AIDS vaccine development. Although creating these networks has been a very challenging task, particularly for management, the intellectual, scientific, and human interactions among the participants have generated true cooperative teams adding a synergistic value to research conduct.
In conclusion, the development of the Tat vaccine programme required a multidisciplinary approach, adequate economic resources, training and a great effort of managing and coordination. The programme has been fully funded and conducted by the ISS, which is the Italian health governmental agency. A great effort was, therefore, dedicated to build up a structure capable of translational research. The accomplishment of this task took 10 years and taught us important lessons (Table 13), at the same time resulting in key achievements. This structure is now ready to run the following clinical phases of the Tat vaccine, as well as new vaccine programmes. In addition, such organization offers the flexibility to update all the different areas of the programme rapidly in response to scientific needs and innovation, with no interference from private/profit interests or ‘fashioned’ scientific agendas, which have undermined targeting regulatory genes as well as conducting therapeutic vaccine trials that may offer new opportunities in HIV treatment. In particular, the parallel conduct of preventive and therapeutic trials with the Tat vaccine candidate has provided important insights into HIV pathogenesis and for the development of a preventive vaccine based on virus control and not on sterilizing immunity. Finally, the creation of networks for vaccine development is greatly helping in this task and provides a suitable forum for training programmes, which are greatly needed in the field.
The authors wish to thank all the personnel at the National AIDS Centre, ISS, and particularly: S. Moretti, M.R. Pavone-Cossutt, F. Nappi, A. Borsetti, M.T. Maggiorella, L. Sernicola, R. Belli, I. Macchia, P. Leone, O. Longo, F. Ferrantelli, S. Bellino, C. Sgadari, D. Bernasconi, E. Fanales-Belasio, L. Tavoschi, and all the personnel from the animal facilities and technical services; the AHL (Division of Epidemiology, MIPI, ISS): A. Luzi, P. Gallo, B. De Mei, A. Colucci, A. Santoro, A. D'Agostini, R. Valli, G. Rezza; Division of Biologic Products, MIPI, ISS: C. Pini; the Joint ISS/S. Gallicano Laboratory site: A. Tripiciano, A. Scoglio, B. Collacchi, M. Ruiz-Alvarez, V. Francavilla, G. Paniccia, A. Fazio, P. Cordiali-Fei, G. Prignano, A. Arancio, F. Stivali; the Institute of Biochemistry, University of Urbino: M.E. Laguardia; the clinical sites: A. Lazzarin, G. Tambussi, R. Visintini (S. Raffaele Hospital, Milan); P. Narciso, A. Antinori, G. D'Offizi, M. Giulianelli (L. Spallanzani Hospital, Rome); A. Di Carlo, G. Palamara, M. Giuliani (S. Gallicano Hospital); M. Carta (University of Rome ‘La Sapienza’); the Adverse Events Monitoring Committee: P. Popoli (Istituto Superiore di Sanità); M. Galli (L. Sacco Hospital, Milan); M. Picardo (San Gallicano Hospital, Rome); and C.F. Perno (University of Rome ‘Tor Vergata’); the Community Advisory Board: R. Iardino (NPS); S. Marcotullio (I-CAB); A. Vatrella (LILA); C. Valvo (GITA); G. Bevacqua (Positifs Onlus); S. Lombardo (M. Mieli); R. Gavioli and P. Marconi (University of Ferrara); S. Barnett (Novartis, Emeryville, USA); M. Robert-Guroff (NCI–NIH, Bethesda, USA); E. Vardas (University of the Witwatersrand, Soweto, South Africa); F.M. Regini and P. Sergiampietri for technical and secretarial support and A. Carinci and S. Ceccarelli for editorial assistance. A particular thanks to all trial volunteers.
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