Descripción del proyecto
Una nueva vacuna para la enfermedad mortal de Chagas
Las enfermedades de transmisión vectorial, propagadas por organismos como insectos portadores de patógenos, representan más del 17 % de todas las enfermedades infecciosas y afectan de manera desproporcionada a personas de las poblaciones más pobres. Una de estas es la enfermedad de Chagas, principalmente presente en países latinoamericanos. En los casos graves, la enfermedad de Chagas puede provocar insuficiencia cardíaca congestiva y parada cardíaca. CRUZIVAX está llevando un candidato a vacuna sin aguja de los ensayos preclínicos en ratones a los ensayos clínicos de fase I en voluntarios sanos. Y, mejor aún, el estudio incluye la fabricación a bajo coste y un análisis de la economía de la salud para fomentar el acceso generalizado en los sistemas sanitarios de los países pobres, que son los más vulnerables.
Objetivo
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.
Ámbito científico
Palabras clave
Programa(s)
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaConvocatoria de subcontratación
H2020-SC1-2018-Two-Stage-RTD
Régimen de financiación
RIA - Research and Innovation actionCoordinador
38124 Braunschweig
Alemania