The consortium of the European RBDCOV project held its first face-to-face meeting yesterday after seven months working telematically. This project, funded by the European Commission's Horizon Europe programme with €9 million, aims to test the efficacy, tolerability and safety of HIPRA's vaccine against COVID-19 in paediatric and immunocompromised population.
Led by HIPRA, the RBDCOV project is driven by an international consortium with 13 organisations from Spain, the UK, Italy, Germany and Turkey. The Girona Biomedical Research Institute (IDIBGI) is one of the organisations participating in this project. Led by the Internal Medicine research group, IDIBGI is recruiting a hundred volunteers for the trial in immunocompromised people, who will soon be receiving the dose at the Hospital Dr. Josep Trueta in Girona.
Last May, the RBDCOV project started the phase III clinical trial of the Covid-19 vaccine in immunocompromised people. This clinical trial will 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. Therefore, it will be studied whether the vaccine is able to reactivate or regenerate a sufficient immune response by increasing the activity of the immune system (natural defences) against the virus. The safety of the new vaccine and whether it is able to prolong the effect of the vaccination already received by the participants will also be studied.
In total, 400 volunteers from three hospitals in Spain and three in Turkey will participate in the study. These are adults with pathologies or immunosuppressive conditions whose immune system may be less responsive to vaccines. The profiles of study participants include people with primary immunodeficiency, including HIV; people 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 certain autoimmune diseases).
As of 29 March 2022, HIPRA is undergoing the European Medicines Agency's (EMA) ongoing review process, which involves the evaluation of existing data on the HIPRA vaccine as it is generated until marketing authorisation, according to the usual EU standards of efficacy, safety and quality. HIPRA expects to receive conditional marketing authorisation in mid-2022. The company is already prepared at the production level to have the vaccine available in a few days.
RBDCOV is one of 11 selected projects that support clinical trials of the new vaccine and can reach beyond Europe's borders by creating links with other European initiatives to address the fight against the coronavirus crisis and strengthen existing research infrastructures. The European Commission has selected 11 projects in total, involving 312 research teams from 40 countries. These projects are part of the Horizon Europe Framework Programme (2021-2027), Europe's largest research and innovation programme, and one of its priorities is to support urgent research on coronavirus and its variants.