The University Hospital of Girona Dr. Josep Trueta is looking for young people between 12 and 17 years of age, both ages included, to participate in a clinical trial on the COVID-19 vaccine of the biotech pharmaceutical company HIPRA. The Spanish Agency of Medicines and Health Products (AEMPS) authorized a few days ago the realization of this clinical trial, which aims to study whether the booster dose of HIPRA's vaccine is safe in adolescents between 12 and 17 years old who have previously been vaccinated with 2 doses of Comirnaty (Pfizer) and to confirm whether this booster dose increases the immune response (defenses) against COVID-19. To do so, we will study if it is well tolerated and if it is able to reactivate an immune response, that is, if the vaccine is able to increase the activity of the immune system (defenses) against the virus and how long its effect lasts. All participants will be evaluated for safety, but the immune response will only be evaluated in those who have not previously passed COVID-19.
Five hospitals in Spain will participate in the study, including the Hospital Trueta, through the professionals of the Pediatric Infectious Diseases Unit. Hospital Vall de Hebron in Barcelona, HM Universitario Puerta del Sur in Madrid, HM Montepríncipe in Madrid and Hospital Universitario La Paz in Madrid will also participate. Between these participating hospitals, they have to recruit up to 300 adolescents to voluntarily participate in the trial.
Young people who wish to participate in the trial must have received two doses of Comirnaty (Pfizer) at least 6 months ago. Whether or not they have passed the COVID-19, they will still be able to participate in the study. A space has been set up on the web page of the centers so that those interested in participating can register. As they are minors, they have to inform the father, mother or legal guardian to proceed with the registration. The interested parties must fill in the following form.
The study is evaluated by the Ethics Committee of HM Hospitales and the Spanish Agency of Medicines and Health Products (AEMPS).
The study begins once HIPRA's COVID-19 vaccine, called BIMERVAX®, has been approved for administration in adults by the European Medicines Agency and the European Commission.
About BIMERVAX® Vaccine
It consists of a bivalent adjuvanted vaccine containing a recombinant protein based on the Beta and Alpha variants of SARS-CoV-2 and is indicated as a booster dose for people older than 16 years. Studies have shown it to be a safe, low reactogenic vaccine with a broad capacity to neutralize the main variants of the virus, including the Omicron variants. In addition, it suggests longer-lasting protection with fewer adverse effects than the mRNA vaccine1,2.
The vaccine is stored at refrigerated temperature, between 2°C and 8°C, facilitating logistics and distribution. It is a "ready-to-use" vaccine, i.e. it does not need to be reconstituted before serving, thus facilitating the task of healthcare personnel.
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