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This clinical trial is part of the European project RBDCOV, led by HIPRA in which Vall d'Hebron participates, whose recruitment is still open.
Vall d'Hebron and four other hospitals in Spain are conducting a clinical trial to study the safety, immunogenicity and efficacy of a booster dose of the COVID-19 adjuvanted recombinant protein vaccine (BIMERVAX®) from the biotech company HIPRA in healthy adolescents. So far, 150 participants have already been included in the study, and preliminary data show optimistic results for the vaccination of this group.
Based on the data obtained so far, it has already been confirmed that this vaccine has proven to be safe, low reactogenic and able to reactivate the immune response against COVID-19, also with respect to currently circulating variants.
“With these initial results we see that it is a suitable vaccine for the pediatric population. It is important to continue research in order to have more robust data that will allow us to have a recombinant vaccine as a booster also in the pediatric population. To this end, it is important to recruit the 300 volunteers needed to complete this study and initiate it in children under 12 years of age”, assures Dr. Pere Soler Palacín, principal investigator of the project, head of the Infectious Pathology and Immunodeficiency Unit of Paediatrics at Vall d'Hebron University Hospital and of the Infection and Immunity in Paediatric Patients group at Vall d’Hebron Research Institute (VHIR).
The study will include a total of 300 adolescents aged between 12 and 18 years, who have already received two doses of Pfizer's Comirnaty at least six months ago, whether they have passed the COVID-19 or not. In this trial, in addition to Vall d'Hebron, Hospital Josep Trueta (Girona), Hospital Universitario de la Paz (Madrid) and the hospitals HM Montepríncipe and Puerta del Sur (Madrid) are participating.
The search for volunteers is still open
Parents or tutors of minors interested in participating in this study can still do so to collaborate in the research of this vaccine, which has been completely developed and manufactured by the biotechnology company HIPRA in our country. To do so, they should contact the team responsible for the work by e-mail or telephone:
The RBDCOV project
This clinical trial is part of the "RBD Dimer recombinant protein vaccine against SARSCoV2" (RBDCOV) project, within the Horizon Europe program. The objective is to test the efficacy, tolerability and safety of HIPRA's recombinant COVID-19 vaccine in children (including adolescents) and immunocompromised individuals.
RBDCOV is one of the international projects committed to test the vaccine against COVID-19 and allows the creation of links with other European initiatives to reinforce existing research infrastructures.
Paediatric Infectious Diseases and Immunodeficiencies Unit,
Children's Hospital and Woman's Hospital
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