Clinical validation of an antibiotic-resistant bacteria global vaccine platform through the first vaccine against Klebsiella pneumoniae

Project Information

K-VAX

Grant agreement ID: 101189068

DOI

10.3030/101189068

EC signature date 12 December 2024

Start date 1 January 2025

End date 31 December 2026

Funded under

• The European Innovation Council (EIC)

Total cost

No data

EU contribution

€ 2 494 748,99

Coordinated by

VAXDYN SL
Spain

Periodic Reporting for period 1 - K-VAX (Clinical validation of an antibiotic-resistant bacteria global vaccine platform through the first vaccine against Klebsiella pneumoniae)

Reporting period: 2025-01-01 to 2025-12-31

Summary of the context and overall objectives of the project

Antimicrobial resistance (AMR) is recognised as one of the most critical threats to global public health. Klebsiella pneumoniae is among the most concerning pathogens due to its high resistance to antibiotics and its association with severe hospital-acquired infections. The increasing prevalence of resistant strains is driving higher mortality rates, longer hospital stays and a growing economic burden on healthcare systems worldwide. There is therefore an urgent need for innovative preventive solutions that go beyond conventional antibiotic treatments.
The K VAX project addresses this challenge by developing a novel vaccine candidate targeting Klebsiella pneumoniae, with the objective of preventing infections in high-risk populations. By focusing on prevention rather than treatment, the project aims to reduce infection rates, limit antibiotic use and contribute to mitigating the spread of antimicrobial resistance.
The overall objective of the project is to advance the K VAX vaccine candidate from preclinical development to clinical validation in humans, generating the scientific, technical and regulatory evidence required to support its safety, immunogenicity and potential efficacy. This includes the preparation and execution of early-stage clinical trials (Phase 1/2), which represent a critical step towards real-world application.
The project is implemented within a highly regulated biomedical framework, requiring close interaction with regulatory authorities and compliance with strict validation standards. Its development pathway combines scientific research, clinical planning and regulatory alignment, ensuring readiness for clinical use and future market access.
Beyond its technical objectives, the project contributes to broader European and global health strategies addressing antimicrobial resistance. By providing a preventive solution to a major unmet medical need, it is expected to:
• reduce the incidence of antibiotic-resistant infections,
• decrease healthcare costs associated with hospitalisation and treatment,
• and support the long-term sustainability of healthcare systems.
From a pathway-to-impact perspective, the project is linked to a long-term deployment strategy based on partnerships with pharmaceutical companies following successful clinical validation, enabling large-scale access to the vaccine.
The K VAX project represents a high-impact innovation initiative with the potential to contribute significantly to the fight against antimicrobial resistance and to improve public health outcomes worldwide.

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

During the first 12 months, the K VAX project has focused on advancing the vaccine candidate towards clinical validation while addressing key scientific and regulatory requirements.
Activities included generating data to support the clinical development plan, refining the clinical strategy, and preparing the technical and regulatory documentation required for clinical trial authorisation. In parallel, the project progressed in defining the conditions for clinical execution, including site identification and collaboration with specialised partners.
A major effort was dedicated to strengthening the supporting data package, including additional validation data to meet quality and safety requirements prior to human testing. These activities ensured alignment with regulatory expectations and readiness for future clinical stages.
As a result, the project has established a solid scientific and technical foundation for the development of K VAX, including the definition of a Phase 1/2 clinical study design and the preparation for clinical trial execution.
Overall, the work carried out has reduced key technical and regulatory uncertainties and strengthened the project’s readiness for the next development phase, providing a robust basis for progressing towards clinical trials and long-term objectives.

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)

The K VAX project advances the state of the art in antimicrobial resistance by developing a preventive vaccine-based approach, shifting from traditional treatment of infections to prevention. This represents a key change in how antimicrobial-resistant pathogens are addressed.
The project focuses on Klebsiella pneumoniae, a major health concern for which there are currently no widely available vaccines, despite its significant role in hospital-acquired infections. By targeting this gap, K VAX aims to reduce infection rates and limit the spread of resistant strains.
The results achieved so far:
• strengthen the foundation for vaccine-based prevention against resistant bacteria,
• improve understanding of the data needed for regulatory approval,
• and integrate scientific research, clinical development and regulatory alignment.
More broadly, the project supports a shift towards prevention-based healthcare models, increasingly recognised as essential for tackling antimicrobial resistance and ensuring long-term sustainability of healthcare systems.
To ensure successful uptake and impact, key factors include:
• completion of clinical development,
• continued access to funding,
• alignment with regulatory requirements,
• effective commercialisation through partnerships,
• and global accessibility of the vaccine.
The K VAX project has the potential to deliver significant advances beyond the current state of the art, contributing to the prevention of resistant infections and supporting the transition towards more sustainable healthcare systems.