The European Commission has granted an extension of 15 months to the RBDCOV project, moving the end date from 31 May 2024 to 31 August 2025. This change will allow the planned number of volunteers to be reached in order to complete the clinical trials and meet the requirements. The aim of the project is to investigate the efficacy, tolerability and safety of the BIMERVAX® COVID-19 vaccine in infants and adolescents.
The vaccine, developed by the pharmaceutical company HIPRA with the participation of other centres such as the Institute for Biomedical Research of Girona Dr. Josep Trueta (IDIBGI) and the Trueta Hospital, was approved by the European Medicines Agency (EMA) last year as a booster for people with HIV. Josep Trueta (IDIBGI) and the Hospital Trueta received approval from the European Medicines Agency (EMA) last year as a booster for people aged 16 years or older who were previously vaccinated with two doses of the COVID-19 mRNA vaccine.
Progress with the study in adolescents aged 12 to 17 years old
The HH-3 study, initiated in May 2023 and led by the Vall d'Hebron University Hospital, has focused on determining whether the booster dose of BIMERVAX® is safe in adolescents aged 12 to 18 years and to confirm whether this booster dose increases the immune response (defences) against COVID-19.
The number of volunteers has grown steadily, with more than 200 adolescents participating in this study. In order to reach the target of 300 volunteers, two new Primary Health Care Centres (CAP), the Peralada CAP in Girona and the Centelles CAP in Barcelona, have joined the clinical trial.
Next: a study with children from 5 to 11 years of age
Once the HH-3 study has been completed and the data from the 300 participants have been analysed, a study will be carried out with another paediatric group. In view of the promising initial results of the HH-3 study, an application for authorisation has been submitted to the EMA to carry out the HH-6 study with children aged 5 to 12 years.
The first part of the HH-6 study will involve the exploration of different doses ("dose-finding") to assess and determine the optimal vaccine dosage that balances efficacy and safety considerations, maximising therapeutic benefits and minimising side effects.
The second part of the study, which examines the vaccine's ability to elicit an immune response ("immunogenicity") over a period of one year, aims to confirm the preliminary positive results observed in adolescents aged 5 to 11 years. These immuno-binding studies allow extrapolation and comparison of vaccine efficacy data between the two groups.
Results in adults living with immunocompromised conditions
In previous phases of the RBDCOV project, the BIMERVAX® vaccine was tested in adults with potentially less vaccine-sensitive immune systems. This study included 240 volunteers with immunocompromised conditions, such as people who have received a kidney transplant or suffer from chronic kidney disease, people in a diary programme, people living with primary immunodeficiency, people with HIV and people with an autoimmune disease undergoing treatment with rituximab (a drug used to treat certain autoimmune diseases and blood cancer).
Vaccination Centres: study with adolescents aged 12 to 17 (HH3)
Parents or guardians of minors interested in participating in this study can contact the research team by email or telephone:
Vall d'Hebron University Hospital (Barcelona)
+34 667 93 56 77 / +34 934 89 31 00 (Extension 3271)
miriam.gonzalezamores@vallhebron.cat / noemi.gimenez@vhir.org
Hospital Dr. Josep Trueta (Girona)
+34 872.98.70.87 (Extensión: 323)
jcastells@idibgi.org / sjane@idibgi.org
hiprahh3@idibgi.org
Hospital HM Montepríncipe (Madrid) and Hospital Puerta del Sur (Madrid)
+34 639 50 13 40 / +34 659 33 61 84
unidadvacunas@hmhospitales.com
Hospital La Paz (Madrid)
+34 608 427 004 / +34 91 727 1644
ucicec.hulp@salud.madrid.org
servicio.pediatria@salud.madrid.org
Peralada Primary Care Centre (CAP) Peralada
+34 97 253 85 87
Primary Care Centre (CAP) Centelles
+34 93 881 04 85
