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Evaluation of ratioNally Designed Influenza vaccines

Project description

DEENESFRITPL

Rational design of influenza vaccine

The EU-funded ENDFLU project aims to develop three next-generation influenza vaccination strategies, capitalising on the expertise of European and Indian partners in rational vaccine design and development. Constructs to elicit humoral immunity build on rationally designed and optimised conserved epitopes of influenza surface proteins, hemagglutinin stem- and head-nanoparticles, and matrix protein 2 ectodomain and influenza neuraminidase fusions either as proteins or expressed as replication-deficient modified vaccinia virus Ankara (MVA). Other MVA-based constructs to elicit cell-mediated immunity will encode internal protein T-cell epitopes, as an artificial poly-epitope. The best candidates selected in the preclinical trials will enter a phase I clinical trial in India assessing safety, immunogenicity and optimal dose. The MVA-based constructs will enter a clinical trial in the EU, assessing safety and immunogenicity, followed by a controlled human infection model study.

Objective

ENDFLU will develop three complementary next-generation influenza vaccination strategies for the world, fueled by the unique combined expertise of Indian and European partners in rational vaccine design and development:
• Create a repository of pre-pandemic GMP-compliant MVA-based vaccine seeds, each encoding an influenza hemagglutinin (HA), based on European partners demonstration of clinical safety and cross-clade immunogenicity of MVA-H5.
• Optimize and select protein- and MVA-based constructs developed by Indian and European ENDFLU partners, resulting in a rationally combined vaccine formulation that induces broadly protective humoral and cell-mediated immunity against all influenza manifestations. This will be advanced in a Phase I clinical trial and Controlled Human Infection Model (CHIM) study.
• Pre-clinically advance other promising protein- and MVA-based constructs toward future development beyond ENDFLU.
Constructs to elicit humoral immunity build on rationally-designed and optimized conserved epitopes of influenza surface proteins, HA stem- and HA head-nanoparticles, and NA-M2e fusions either as proteins or MVA expressed. Other MVA-based constructs to elicit cell-mediated immunity will encode conserved internal protein T cell epitopes, as an artificial polyepitope. The best candidates will be selected based on biochemical, biophysical, functional and manufacturing criteria, and immunogenicity and protective efficacy in mice and ferrets. The selected protein-based construct will enter a Part A Phase I clinical trial in India assessing safety, immunogenicity and optimal dose, to be combined with the selected MVA-based construct. This protein-MVA combination will enter a Part B Phase I clinical trial in the EU, assessing safety and immunogenicity, followed by the CHIM study. A dissemination and exploitation plan, and collaboration with key scientific advocacy organizations will facilitate the adoption of ENDFLU achievements to combat influenza worldwide.

Fields of science

Programme(s)

Topic(s)

Call for proposal

H2020-SC1-BHC-2018-2020

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Sub call

H2020-SC1-2019-Single-Stage-RTD

Funding Scheme

RIA - Research and Innovation action

Coordinator

STIFTUNG TIERAERZTLICHE HOCHSCHULE HANNOVER
Net EU contribution
€ 1 234 225,00
Address
Bunteweg 2
30559 Hannover
Germany

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Region
Niedersachsen Hannover Region Hannover
Activity type
Higher or Secondary Education Establishments
Links
Other funding
€ 0,00

Participants (13)

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EC signature date 12 December 2019
Last update: 31 October 2022

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Permalink: https://cordis.europa.eu/project/id/874650

European Union, 2023