Description du projet
Un nouveau vaccin contre une maladie meurtrière, la maladie de Chagas
Les maladies à transmission vectorielle, propagées par des organismes comme les insectes vecteurs d’agents pathogènes, représentent plus de 17 % de toutes les maladies infectieuses et touchent de manière disproportionnée les populations les plus pauvres. La maladie de Chagas, qui sévit principalement dans les pays d’Amérique latine, en fait partie. Dans les cas graves, la maladie de Chagas peut provoquer une insuffisance cardiaque congestive et un arrêt cardiaque. CRUZIVAX porte un vaccin sans aiguille candidat des essais précliniques sur la souris aux essais cliniques de phase 1 chez des volontaires en bonne santé. Mieux encore, l’étude inclut une fabrication à faible coût et une analyse de l’économie de la santé pour permettre un accès généralisé aux systèmes de santé des pays pauvres les plus vulnérables.
Objectif
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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RIA - Research and Innovation actionCoordinateur
38124 Braunschweig
Allemagne