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Vaccine for prevention and treatment of Trypanosoma cruzi infection

Vaccine for prevention and treatment of Trypanosoma cruzi infection

Objective

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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Coordinator

HELMHOLTZ-ZENTRUM FUR INFEKTIONSFORSCHUNG GMBH

Address

Inhoffenstrasse 7
38124 Braunschweig

Germany

Activity type

Research Organisations

EU Contribution

€ 2 070 198,15

Participants (10)

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UNIVERSIDAD DE BUENOS AIRES

Argentina

EU Contribution

€ 745 500

UNIVERSIDADE NOVA DE LISBOA

Portugal

EU Contribution

€ 442 206,25

COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES

France

EU Contribution

€ 963 795,49

INSTITUTO DE BIOLOGIA EXPERIMENTAL E TECNOLOGICA

Portugal

EU Contribution

€ 352 356,64

GENIBET - BIOPHARMACEUTICALS SA

Portugal

EU Contribution

€ 861 249,50

ASA SPEZIALENZYME GMBH

Germany

EU Contribution

€ 951 500

ATRC AURIGON TOXICOLOGIAI KUTATOKOZPONT KORLATOLT FELELOSSEGU TARSASAG

Hungary

EU Contribution

€ 863 592,50

UNIVERSITEIT ANTWERPEN

Belgium

EU Contribution

€ 577 302,76

FUNDACION PRIVADA INSTITUTO DE SALUD GLOBAL BARCELONA

Spain

EU Contribution

€ 253 401,50

VAKZINE PROJEKT MANAGEMENT GMBH

Germany

EU Contribution

€ 310 137,50

Project information

Grant agreement ID: 815418

Status

Ongoing project

  • Start date

    1 June 2019

  • End date

    31 May 2024

Funded under:

H2020-EU.3.1.3.

Coordinated by:

HELMHOLTZ-ZENTRUM FUR INFEKTIONSFORSCHUNG GMBH

Germany