The trial, part of the RBDCOV project, will involve 300 participants and will take place in 5 hospitals in Spain
The Spanish Agency for Medicines and Health Products (AEMPS) has authorized a clinical trial of HIPRA’s COVID-19 vaccine to determine if the booster dose of the HIPRA COVID-19 vaccine is safe in adolescents aged 12 to under 18 who have previously been vaccinated with 2 doses of Comirnaty (Pfizer) and to confirm if this booster dose increases the immune response (defenses) against COVID-19. The study is part of the RBDCOV project, which aims to test the efficacy, tolerability, and safety of the HIPRA vaccine for COVID-19.
To do so, it will be studied whether it is well tolerated and whether it is able to reactivate an immune response, that is, whether the vaccine is capable of increasing the activity of the immune system (defenses) against the virus and how long its effect lasts. Safety will be evaluated in all participants, but the immune response will only be evaluated in those who have not previously had COVID-19.
The study, which will involve 300 adolescents aged 12 to under 18, will take place in 5 hospitals in Spain: Vall d’Hebron Hospital in Barcelona, Josep Trueta Hospital in Girona, HM Universitario Puerta del Sur in Madrid, HM Montepríncipe in Madrid, and La Paz University Hospital in Madrid. These hospitals have already begun recruiting volunteers. The study begins once the HIPRA COVID-19 vaccine, called BIMERVAX®, has been approved by the European Medicines Agency and the European Commission.
People who want to participate in the trial must have received at least 2 doses of Comirnaty (Pfizer) at least 6 months ago. In the case of having had COVID-19, they can still participate in the study. Each hospital has set up a space on its website for interested people to register. As minors, they must inform their father, mother, or legal guardian to proceed with registration.
The study will be evaluated by the Ethics Committee of HM Hospitals and the Spanish Agency for Medicines and Health Products (AEMPS).
RBDCOV is one of 11 selected projects that support clinical trials of the new vaccine and that can go beyond the borders of Europe by creating links with other European initiatives to address the fight against the coronavirus crisis and reinforce existing research infrastructures. The European Commission has selected a total of 11 projects in which 312 research teams from 40 countries participate. These projects are part of the Horizon Europe Framework Program (2021-2027), the largest research and innovation program in Europe, and one of its priorities is to support urgent research on the coronavirus and its variants.
About the BIMERVAX® vaccine
It consists of a bivalent adjuvanted vaccine that contains a recombinant protein based on the Beta and Alpha variants of SARS-CoV-2 and is indicated as a booster dose for people over 16 years of age. In studies, it has been shown to be a safe vaccine, with little reactogenicity and with a wide capacity to neutralize the main variants of the virus, including the Omicron variants. In addition, it suggests longer-lasting protection and fewer adverse effects than mRNA vaccines.
The vaccine is stored at refrigerated temperatures between 2°C and 8°C, facilitating its logistics and distribution. It is a “ready-to-use” vaccine, meaning that it does not need to be reconstituted before use, thus making the task easier for healthcare personnel.