Descrizione del progetto
Un nuovo vaccino per la mortale malattia di Chagas
Le malattie trasmesse da vettori, diffuse da organismi quali insetti portatori di agenti patogeni, rappresentano oltre il 17 % di tutte le malattie infettive e colpiscono in maniera spropositata le persone delle popolazioni più povere. Una di queste è la malattia di Chagas, prevalente principalmente nei paesi dell’America Latina. Nei casi più gravi, la malattia di Chagas può causare insufficienza cardiaca congestizia e arresto cardiaco. Il progetto CRUZIVAX sta portando un candidato vaccino senza ago dalle sperimentazioni precliniche sui topi a una sperimentazione clinica di Fase I su volontari sani. Ancora meglio, lo studio include la produzione a basso costo e un’analisi degli aspetti economici dell’assistenza sanitaria per supportare l’accesso diffuso da parte dei sistemi sanitari nei paesi poveri che sono i più vulnerabili.
Obiettivo
Chagas is a neglected disease endemic in 21 Latin-American countries caused by Trypanosoma cruzi. It is the largest parasitic disease burden in the Americas (>11,000,000 chronic infections) and the first cause of cardiac morbidity in poor rural/suburban areas. It became a worldwide concern as a result of mass migration with reports in 19 non-endemic areas (>1.3 million carriers in EU/USA). Treatment is difficult since acute infections have mild symptoms and remain largely unnoticed evolving to chronicity. Drug therapy is also long, often associated with side effects (10-30% interruption) and only active during early infection. The main objective of CRUZIVAX is to bridge the gap between preclinical and clinical development by performing preclinical and clinical phase 1 studies of a needle-free vaccine against T. cruzi with proven efficacy in preclinical models. The vaccine is based on a structure-engineered trivalent chimeric antigen lacking immune decoy sequences and an adjuvant promoting self-limited locally-restricted immune activation stimulating humoral and cellular immunity, which is expected to protect as prophylactic or therapeutic (combined with Benznidazole) vaccine. To achieve this CRUZIVAX will: (i) conduct preclinical studies in mice to assess immunogenicity and efficacy of different vaccine formulations in prophylactic and therapeutic settings, (ii) analyse the immunogenicity and efficacy of the best vaccine formulation in dogs and non-human primates, (iii) produce cGMP antigen and adjuvant by cost-efficient manufacturing (facilitated uptake by health systems with limited resources), (iv) perform a preclinical safety assessment of the vaccine, (v) conduct a phase 1 vaccine clinical trial in healthy volunteers, and (vi) carry out a health economics analysis to identify critical target-product profile parameters. The vaccine will strengthen the pipeline of products for Chagas disease, aimed at reducing disease burden and its social and economic impact.
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Vedi altri progetti per questo bandoBando secondario
H2020-SC1-2018-Two-Stage-RTD
Meccanismo di finanziamento
RIA - Research and Innovation actionCoordinatore
38124 Braunschweig
Germania