The RBDCOV project consortium gets to know the HIPRA facilities

The RBDCOV project is funded by the Horizon Europe programme and led by the biotech pharmaceutical company HIPRA. Its objective is to test the efficacy, tolerability, and safety of the recombinant Covid-19 vaccine in children (including adolescents) and immunocompromised people. The project will last two and a half years and will have a budget of more than nine million euros.

RBDCOV has an international consortium comprising 13 organisations from five countries which, after seven months of working remotely, met on 29 June for the first face-to-face consortium meeting at HIPRA’s premises. The partners come from Spain, the UK, Italy, Germany, and Turkey and cover a wide range of different fields in which they specialise.

Indeed, the proposed strategy benefits from the partners’ expertise in different fields, allowing the following issues to be addressed which should allow significant progress to be made: Flexible platform ready to generate antigens of any future variant; Inclusion of immunocompromised children and adults; Booster for future vaccination campaigns; Other challenges associated with COVID vaccination (which also have an ethical, economic and psychosocial dimension) to take into account the vision of the patient for the design of the clinical trial, of policymakers and the general public in Europe, and finally, to understand the importance and limits of the development of new vaccines in a pandemic situation where society is involved in following the progress of products that are going to be rapidly used in the population.

Zabala Innovation leads the Communication and Dissemination of the project and collaborates in the conception and execution of the Exploitation and Marketing Plan, as well as in the Management tasks involved in the project.

Project development

RBDCOV project plans to conduct two clinical trials to test its vaccine. One in a group of people with compromised immune systems and a second study with several groups of children and adolescents.

Currently, with the project having been working together for seven months, efforts are focused on phase III clinical trial of the COVID-19 vaccine in immunocompromised individuals, after the Spanish Agency for Medicines and Health Products (AEMPS) authorised it on 9 May. The trial is expected to determine whether an additional dose of HIPRA’s Covid-19 vaccine can generate an immune response in people living with immune system disorders, such as immunodeficiencies or receiving immunosuppressive treatments. To achieve this, they are studying whether the vaccine can reactivate or re-generate a sufficient immune response by increasing the activity of the immune system against the virus.

The trial will involve 400 volunteers from three hospitals in Spain and three in Turkey. These are adults with pathologies or immunosuppressive conditions whose immune systems may be less responsive to vaccines. Participants include people with primary immunodeficiency (including HIV), those who have received a kidney transplant or have kidney disease, people on dialysis, and people receiving treatment with Rituximab (a drug used to treat some of the existing autoimmune diseases).

Future outlook

As of March 2022, HIPRA is in the process of an ongoing review by the European Medicines Agency (EMA), which means that existing data on its vaccine will be evaluated as they are generated until it is granted marketing authorisation according to the usual EU standards of efficacy, safety, and quality. HIPRA is expected to receive conditional marketing authorisation in mid-2022.

• #Horizon Europe