The project is focused on the development of mucosal vaccines against AIDS and tuberculosis (TB) and is based on the use of antigens validated as safe and effective in animal models Mucosal vaccines present advantages of practical and social relevance when compared to parenteral. To ensure vaccine compliance, accessibility, and coverage, vaccines should be designed which can be administered by convenient mucosal routes of delivery. Mucosal vaccines, inducing both local and systematic immune responses, are considered more effective in controlling mucosally-acquired infections, such as HIV and TB The project consists of two major parallel interlinked tracks: (i) phase I trials of mucosal immunization using antigens and adjuvants validated in previous preclinical and clinical studies (ii) development of new candidate vaccines for mucosal immunization and their comparative selection in animal models. Antigens such as GAg, V2- deleted gp 120, Tat (HIV-1), and Ag85B/ESAT-6 hybrid molecule (TB), and adjuvants such as LTK63 and HSP70, will be used in combination for phase I trials to be performed first in Europe and than in Africa Development of new vaccine candidates will not include antigen discovery but would rather be based on the novel use of adjuvants and delivery systems in combination with promising antigens. Animal models of increasing relevance for human vaccines will be used to compare new candidates and to select those which should proceed to phase I trials The final expected result of this Project is to provide candidate mucosal vaccines, with proved safety and immunogenicity in humans, that could subsequently enter the path towards licensure through phase II and III clinical trials The European Developing Countries Clinical Trials Partnership which is expected to be soon operative could be instrumental in exploiting the results obtained in this project by testing mucosal vaccines against these devasting diseases in developing countries
Keywords:
Mucosal Vaccines, Mycobacterium tuberculosis, Tuberculosis, HIV, AIDS
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