RBDCOV – RBD Dimer recombinant protein vaccine against SARSCoV2

Why?

Vaccines have proven to be the most effective tool to prevent COVID-19. As a result of the RBDCOV project, a novel recombinant protein vaccine against SARS-CoV-2 variants will be validated in clinical trials phase IIb for its use in children and adolescents and in people with immunocompromising conditions.

The progress of the pandemic in Europe in the first quarter of 2020, ignited the interaction of biotechnological/companies like HIPRA with European clinical and health centres (IDIBAPS, FLS, IrsiCaixa, VHIR) to identify new pathways for vaccine manufacturing and to count on them to serve as key diagnostic members to control and minimise the impact of the pandemic. This close collaboration launched the proof of concept of the RBDCOV vaccine and generated optimistic pre-clinical results for the Wuhan sequence, that has allowed the consortium to be ready to initiate phase IIb clinical trials.

Due to the current urgency to bring new vaccines to the market, this new vaccine has been tested in healthy adults in clinical trials phase I/II before the project began. As it happens with many viruses, due to the large population infected and the rate of infection and transmission, SARSCoV-2 is showing significant rates of mutations that can influence the effectiveness of different vaccines when widely implemented in regions where new variants emerge. This means that it is imperative to find platforms that allow the vaccines to be quickly modified according to the new viral variants to ensure the highest possible effectiveness.

What?

The RBDCOV project´s main objective is to test the efficacy, tolerability and safety of the HIPRA adjuvanted recombinant protein vaccine for COVID-19 in children and adolescents and people with immunocompromising conditions, a subset of special populations that have been so far excluded from most Phase 3 efficacy vaccine studies, one of the current biggest clinical development gaps. The project will last 2.5 years.

The aim of the project is to focus not only on the original SARS-CoV-2 variants, but also on other emerging variants d. Thus, a continuous monitoring of the new emerging variants will be performed throughout the project to ensure that the platform is prepared to cope with the virus. The platform used for the generation of the vaccines is adaptable to variants and will be ready to include any other potential variants that could appear in short, medium and large term in the study design.

This work will be crucial to tackle issues related to vaccine uptake that the pandemic has exposed; dealing with adult vaccination and limited experience in managing it, vaccine hesitancy has increased steadily in over 90% of countries since 2014. Given the potential to undermine vaccination coverage, it is crucial to take steps to understand the extent and nature of hesitancy and to start promoting approved COVID-19 vaccines as those that RBDCOV will design.

In particular, participants in the trials and other community members will be engaged through different patient or community associations networks like EATG and PENTA. A Community Advisory Panel (CAP) will be created and specific tools for their engagement will be generated. In addition, the potential psychosocial impact of the vaccines will be evaluated. Involvement of community is especially critical for ensuring the testing of COVID-19 vaccines in specific populations, i.e. People living with HIV, that have been largely excluded from Phase 3 trials with already authorised SARS-CoV-2 vaccines and vaccine-related immune responsiveness is unclear in this population, who are at higher risk of severe COVID-19.

Specific objectives:

• To perform a Phase IIb clinical study of vaccine in paediatric individuals without immunocompromising conditions.
• To perform a Phase IIb/III trial in a cohort of adults with immunocompromising conditions.
• To achieve a recombinant protein vaccine that can potentially be used as an annual booster, independently of the vaccine used in the primary vaccination.
• To manufacture and tune COVID-19 recombinant protein vaccines by using an innovative, flexible/adaptable and scalable platform.
• To design a clearly path to authorisation and commercialisation of the vaccine with the EMA and other regulatory bodies generating a regulatory roadmap for vaccines against COVID-19.
• To involve the general public and people with immunocompromising conditions, as a community through EATG in the project´s design and execution of phase IIb/III testing. In addition, the RBDCOV project aims to establish a solid strategy for communication and dissemination by collaborating with key stakeholders and initiatives as the large European trial networks indicated on the topic.

With whom?

The Project is being implemented by an international consortium that includes companies and institutions from five European countries: Spain (HIPRA, IRSICAIXA, FUNDACIO HOSPITAL UNIVERSITARI VALL D’HEBRON, FUNDACION FILS DE LUCHA CONTRA ELSIDA (FLS), IDIBAPS, IDIBGI, ASPHALION, VINCES CONSULTING, ZABALA INNOVATION), United Kingdom (VERISTAT INTERNATIONAL), Italy (FONDAZIONE PENTA), Germany (EUROPEAN AIDS TREATMENT GROUP), and Turkey (METPHARM ARASTIRMA GELISTIRME SAGLIK DANISMANLIK).

This project will include the point of view of the general public with a special focus on population groups that have not been involved in the development of other vaccines: children and adolescents (PENTA), people living with immunocompromising conditions (EATG) as well as other experts at the European level in different areas of knowledge (Metpharm, VERISTAT, Vinces).

How?

The RBDCOV project foresees two clinical trials; one in a group of people with immunocompromising conditions and the second study in children and adolescents. The RBDCOV project will contribute to the development of the HIPRA vaccine which aims to protect against severe COVID infection to ensure a long-term immune response.

Work on the Project will focus on the following:

• An innovative/flexible platform to manufacture recombinant proteins where the RBD can contain any sequence of variants of SARS-CoV-2;
• A safe and easy to handle formulation, combining the RBD with one of the most used adjuvants in human vaccines;
• Smart clinical trial design and development to validate the efficacy and safety of the vaccine against SARS-CoV- 2;
• Immunogenicity analysis;
• Open innovation involving key stakeholders;
• Community engagement and psychosocial impact;
• Solid path to the market.

For what outcome?

Expected outcomes:

• New vaccine against SARS-CoV-2 and its variants as a booster and as a primary vaccine.
• New technological platform that allows in 4-5 months to adapt the vaccine to future variants.

EATG contact person(s):	Fiona Greenhalgh – fiona.greenhalgh@eatg.org
Duration of the project/initiative:	Start date December 1, 2021 / Duration: 45 months
Project/Initiative Leader:	HIPRA
Project/initiative Main Partner(s):	HIPRA, IrsiCaixa, VHIR, PENTA, FLS, EATG, IDIBAPS, Metpharm, IDBGI, ASPHALION, VINCES, ZABALA
Budget:	Total: 9.779.212,00 €
Main Funding Sources:	Horizon Europe programme (HORIZON-HLTH-2021-CORONA-01)
Links:	https://rbdcov.eu/
Communication Disclaimer:	The RBDCOV project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101046118 Views and opinions expressed are those of the author(s) only and do not necessarily reflect those of the European Union. Neither the European Union nor the granting authority can be held responsible for them.