"PRe-clinicAl studies of a PSA-based human vaccine.. (RAPSODI)
"PRe-clinicAl studies of a PSA-based human vaccine candidate targeting visceral, cutaneOus and mucocutaneous Leishmaniasis and Development of the associated procedures for further clinical trials"
Start date: 01 Jan 2009,
End date: 30 Jun 2012
"The global aim of RAPSODI is : · to develop a human vaccine candidate against most or all Leishmania species that cause the most severe leishmaniasis in the world. An unique vaccinal solution will thus be provided to protect against the various clinical phenotypes (namely visceral, cutaneous and mucocutaneaous leishmaniasis, VL, CL and ML respectively). · to establish all the associated procedures required for the subsequent clinical trials, such as the selection of the appropriate patients and assessment of vaccine efficiency. For that purpose, an international consortium constituted of countries from endemic areas (India, Peru, Tunisia, Spain and France) and embracing multi-disciplinary approaches has been set-up. Based on successful results on VL dogs, the best VL animal model to date, RAPSODI will propose a second generation human-compatible vaccine candidate and confirm its activity in pre-clinical studies. As the chosen antigen is common to most, if not all, Leishmania species, an ambitious universal immunoprotective response is being sought. RAPSODI will also address the question of population selection in order to ascertain relevant and meaningful clinical trials and vaccination campaigns. Indeed, resistant individuals, when involved in either vaccinated or placebo groups, represent important bias to the analysis of the results. RAPSODI will investigate further the parasitological, immunological and genetic features of such clinical status, and will subsequently apply the generated knowledge to the development of assays and field tests, which represent stand-alone results. The package (vaccine candidate + diagnostic/prognostic tools) proposed by RAPSODI represents a global solution, and as such is believed to have a real impact on the worldwide leishmaniasis problem."
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