The international consortium driving the RBDCOV project met for the first time, after 7 months of remote work, on 29 June at the HIPRA premises for the first face-to-face meeting. It has an international consortium that includes 13 organisations from Spain, the UK, Italy, Germany, and Turkey and covers a wide range of different fields in which they are specialised.
The RBDCOV project is funded by the Horizon Europe programme and is led by the biotech pharmaceutical company HIPRA. It aims to test the efficacy, tolerability, and safety of the recombinant Covid-19 vaccine being developed by HIPRA in children (including adolescents) and immunocompromised individuals. The project has a duration of two and a half years and a budget of more than 9 million euros.
The proposed strategy benefits from the experience of the partners in different fields, allowing us to address the following issues that should allow for a significant breakthrough: 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-19 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.
The RBDCOV project foresees 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 7 months, efforts are focused on the 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 is able to 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 is able to 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 system 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 who are receiving treatment with Rituximab (a drug used to treat some of the existing autoimmune diseases).
What to expect next from RBDCOV
As of March 2022, the Covid-19 vaccine being developed by HIPRA is undergoing a rolling review process by the European Medicines Agency (EMA). It involves evaluating existing data on its vaccine as it is 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.