NEXT GENERATION VACCINES AGAINST GASTROINTESTINAL MUCOSAL PATHOGENS, USING HELICOBACTER PYLORI AS MODEL PATHOGEN

Project Information

Vax2Muc

Grant agreement ID: 101080486

DOI

10.3030/101080486

EC signature date 14 April 2023

Start date 1 July 2023

End date 30 June 2028

Funded under

• Health

Total cost

€ 8 219 842,50

EU contribution

€ 8 219 842,50

Coordinated by

TECHNISCHE UNIVERSITAET MUENCHEN
Germany

Periodic Reporting for period 1 - Vax2Muc (NEXT GENERATION VACCINES AGAINST GASTROINTESTINAL MUCOSAL PATHOGENS, USING HELICOBACTER PYLORI AS MODEL PATHOGEN)

Reporting period: 2023-07-01 to 2024-12-31

Summary of the context and overall objectives of the project

In recent years, antimicrobial resistance (AMR) has emerged as a global health threat, with the potential to endanger vast segments of the population. However, developing new vaccines remains a complex challenge, particularly for bacterial infections that colonize specific regions such as the gastrointestinal (GI) tract.
Against this backdrop, the Vax2Muc project is dedicated to pioneering novel vaccination technologies that can overcome local immune tolerance and stimulate long-term protective immunity at mucosal surfaces. The project uses Helicobacter pylori — a chronic bacterial infection affecting nearly 50% of the global population—as a model to evaluate, optimize, and prioritize different vaccination strategies. Left untreated, H. pylori can progress to gastric cancer, making it a significant public health concern.
The project’s key objectives include the development of an H. pylori lead vaccine candidate that will finally be evaluated in a clinical phase I study focusing on both immunogenicity and safety, as well as the development of novel vaccine technologies and strategies to to advance the development of effective mucosal vaccines.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The lead candidate vaccine antigen was successfully designed, produced, and prioritized based on preclinical studies in mice. Pre-GMP material was delivered for preclinical studies. Antigen and adjuvant were formulated for administration and evaluated in first preclinical mouse studies, showing high immunogenicity.
Furthermore, first novel vaccine technologies were developed and are ready for preclinical evaluation in mice and pigs.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Vax2Muc pursues several ambitions and progresses beyond the state of the art. A subunit fusion vaccine consisting of two H. pylori antigens was successfully developed by advanced GMP manufacturing. The lead candidate was evaluated in preclinical mouse studies. By using novel safe and potent adjuvants/delivery systems which are applicable via mucosal routes, Vax2Muc aims the induction of strong mucosal immune responses. Further research on the lead candidate will be conducted in the next reporting period to pave the way to a clinical trial.

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