RBD Dimer recombinant protein vaccine against SARSCoV2

Project Information

RBDCOV

Grant agreement ID: 101046118

DOI

10.3030/101046118

Project closed

EC signature date 12 November 2021

Start date 1 December 2021

End date 31 August 2025

Funded under

• Health

Total cost

€ 9 779 211,26

EU contribution

€ 9 779 211,25

Coordinated by

HIPRA SCIENTIFIC SL
Spain

Periodic Reporting for period 2 - RBDCOV (RBD Dimer recombinant protein vaccine against SARSCoV2)

Reporting period: 2023-03-01 to 2024-05-31

Summary of the context and overall objectives of the project

RBDCOV aims to test the efficacy, tolerability, and safety of the HIPRA vaccine for COVID-19. HIPRA's vaccine is an adjuvanted recombinant protein vaccine, based on a receptor binding domain (RBD) fusion heterodimer against SARS-CoV-2. RBDCOV aims to generate robust data to demonstrate the safety and immunogenicity of this vaccine given as a booster vaccination to induce a higher and more durable immune response, for potential new variants. It should be effective in the prevention of COVID-19.

The initiative is an innovative vaccine-focused research project that brings together the expertise of a number of European organisations and companies.To achieve the project objectives, it is crucial involve as many European stakeholders as possible. That is why the RBDCOV consortium rely on the expertise and the experience of the 12 project partners. The RBDCOV benefits from the perspective of specific populations, i.e. People with immunocompromising conditions, that have been largely excluded from Phase III trials with already authorised SARS-CoV2 vaccines, as vaccine-related immune responsiveness is unclear in this population, who are at higher risk of severe COVID-19.

https://rbdcov.eu/

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 second reporting period (RP2), the RBDCOV project made substantial progress in testing the efficacy, safety, and tolerability of the HIPRA-developed COVID-19 vaccine (BIMERVAX®) in vulnerable groups. Key milestones included paediatric trials with 350 children and trials for 240 immunosuppressed adults. Manufacturing capabilities were enhanced, and new formulations were developed for emerging variants. Significant regulatory and public engagement efforts were made, positioning the vaccine for broad use and commercialization.

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)

An ideal COVID-19 vaccine should have high protective efficacy and be safe and deployable for billions of potential vaccinees. To achieve this goal, an optimal vaccine target, platform and dose regimen are important . Therefore, development of a range of COVID-19 vaccines with different mechanisms of action would be beneficial to diversify the global vaccine pipeline.

RBDCOV is an ambitious project that will offer a new tool to control the pandemic at short-medium and long term. RBDCOV aims to manufacture and test the first recombinant protein-based vaccine to be authorised in Europe beyond the framework of the project. The final formulation of RBDCOV vaccine based on the results on safety and efficacy (obtained during the assessment of different formulations, the experience of the company in using highly innovative platforms for vaccine manufacturing in animals and the solid consortium included in the RBDCOV project will make feasible to settle the bases for this challenging objective.

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