Vall d’Hebron and five other hospitals around Spain are taking part in a clinical trial to find out whether the COVID-19 booster dose (BIMERVAX®) developed by the Spanish biotech company HIPRA is safe for adolescents, and to see if it can reactivate an immune response and how long the effect lasts.

The study involves 300 adolescents between 12 and 18 years of age, who have received two doses of Pfizer Comirnaty at least six months previously, whether or not they have had COVID-19.

The VHIR played an active part in the clinical trial for HIPRA, leading to approval of its administration from the Spanish Agency of Medicines and Medical Devices (AEMPS). BIMERVAX® is an adjuvanted recombinant protein vaccine, based on a receptor binding domain (RBD) fusion heterodimer, containing the SARS-CoV-2 variants B.1.1.7 (alpha) and B.1.351 (beta).

The HIPRA vaccine can be kept at refrigerator temperature (2 to 8º C), thus simplifying storage and distribution. In addition, the technology used is highly versatile in adapting to new variants of the virus, should this be necessary in the future. The results obtained so far show that the vaccine produces neutralising antibodies against current variants of concern (VOCs) and is effective in preventing the disease.

Along with Vall d’Hebron, also involved in the trial are Hospital Trueta (Girona), Hospital Universitario de la Paz (Madrid), HM Montepríncipe (Madrid), and HM Universitario Puerta del Sur (Madrid). 

The RBDCOV project

This clinical trial is part of the “RBD Dimer recombining incidents against SARSCoV2” (RBDCOV) project, part of the Horizon Europe programme. The aim is to test the efficacy, tolerability and safety of the recombinant COVID-19 vaccine in children (including adolescents) and immunocompromised people.

RBDCOV is one of the international projects testing the new vaccine against COVID-19 and helps create links with other European initiatives to re-enforce existing research infrastructures.

Parents or guardians of children interested in taking part in this study should get in touch by email or at the phone number below:

• +34 667 93 56 77 / 934 89 31 00 (Extension 3271) 
• miriam.gonzalezamores@vallhebron.cat
• stephany.zelada@vhir.org