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RBDCOV PROJECT

RBDCOV project starts its first clinical trial against COVID-19

Clinical Trial

The RBDCOV project initiates a Phase III clinical trial of the Covid-19 vaccine in immunocompromised people, after the Spanish Agency for Medicines and Health Products (AEMPS) authorised it on 9 May. 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 can reactivate or re-generate 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 can prolong the effect of the vaccination already received by the participants will also be studied.

Zabala Innovation leads the Communication and Dissemination of the project and collaborates on the Exploitation and Marketing Plan. The project is a communication challenge in Health area and is considered a strategic project for European innovation-seeking global impact. 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.

Details about the clinical trial

The study 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. The profiles of study 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 certain autoimmune diseases).

This clinical trial, led by HIPRA, a Spanish multinational pharmaceutical, and biotechnology company, is being conducted as part of the EU-funded RBDCOV project, which also includes clinical trials with children and adolescents.

As of 29 March 2022, HIPRA is immersed in the European Medicines Agency’s (EMA) ongoing review process, which consists of evaluating existing data on the HIPRA vaccine as they are generated until it is authorised for marketing, according to the usual European Union standards on 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.

 

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