The trial, which will involve 300 participants, will be carried out in 5 hospitals in Spain.
The Spanish Agency of Medicines and Health Products (AEMPS) has authorized a clinical trial of the vaccine against COVID-19 from the biotechnology pharmaceutical company HIPRA to find out whether the booster dose of HIPRA's COVID-19 vaccine is safe in adolescents between 12 and under 18 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, it will be studied if it is well tolerated and if it is able to reactivate an immune response, in other words, if the vaccine is able to increase 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 passed COVID-19.
The study, which will involve 300 adolescents between 12 and under 18 years of age, will involve 5 hospitals in Spain: Hospital Vall d'Hebron in Barcelona, Hospital Josep Trueta in Girona, HM Universitario Puerta del Sur in Madrid, HM Montepríncipe in Madrid and Hospital Universitario La Paz in Madrid. These hospitals have already begun recruiting volunteers. 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.
People who want to participate in the trial must have received two doses of Comirnaty (Pfizer) at least 6 months ago. Whether or not they have passed COVID-19, they will still be able to participate in the study. Each hospital has set up a space on its website so that those interested can enroll. As they are minors, they must inform their father, mother or legal guardian in order to proceed with the enrollment.
The study will be evaluated by the Ethics Committee of HM Hospitales and by the Spanish Agency of Medicines and Health Products (AEMPS).
About BIMERVAX® vaccine
BIMERVAX® is 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 of age1, 2, 3. In the studies, it has been shown to be a safe, low reactogenic vaccine with a broad ability 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 2ºC and 8ºC, facilitating logistics and distribution. It is a "ready-to-use" vaccine, i.e., it is not necessary to reconstitute it before use, thus facilitating the task of healthcare personnel.
About the RBDCOV project
This study is part of the RBDCOV project. RBDCOV is one of 11 selected projects that support clinical trials of the new vaccine and may 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 fall under the Horizon Europe Framework Program (2021-2027), Europe's largest research and innovation program, and one of its priorities is to support urgent research on coronavirus and its variants.
Hospital Vall d’Hebron de Barcelona:
93 489 31 00 ext. 3271
Hospital Universitario La Paz de Madrid:
608 427 004 / 91 727 1644
HM Montepríncipe and HM Puerta del Sur:
639 50 13 40
659 33 61 84
Hospital Josep Trueta de Girona:
1. BIMERVAX® Data Sheet
2. Corominas J, Garriga C, Prenafeta A, Moros A, Canete M, Barreiro A, et al. Safety and immunogenicity of the protein-based PHH-1V compared to BNT162b2 as a heterologous SARS-CoV-2 booster vaccine in adults vaccinated against COVID-19: a multicentre, randomised, double-blind, non-inferiority phase IIb trial. Lancet Reg Health. 2023; doi https://doi.org/10.1016/j.lanepe.2023.100613
Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union. Neither the European Union nor granting authority can be held responsible for them.