Significant advancements and fifteen month extension for the RBDCOV project

25 Jun, 2024

The European Commission has granted a 15-month extension to the RBDCOV project, allowing researchers additional time to recruit volunteers for the HH-3 clinical trial. This trial assesses the efficacy, tolerability, and safety of the BIMERVAX® COVID-19 vaccine as a booster shot in adolescents aged 12 to 17.

The project, led by Vall d’Hebron University Hospital, has seen encouraging progress with over 240 volunteers already enrolled. To achieve the target of 300 participants, two new Primary Care Centres have joined the initiative.

Positive initial results from the project have paved the way for an authorisation request submitted to the European Medicines Agency (EMA) for the HH-6 study, the next phase which aims to evaluate the BIMERVAX® vaccine in children aged 5 to 11. The study will involve a dose-finding component to determine the optimal dosage for this age group and assess the vaccine’s ability to elicit a lasting immune response over a year.

The RBDCOV project offers a glimmer of hope for individuals with compromised immune systems as earlier phases successfully tested the BIMERVAX® vaccine in adults with conditions potentially hindering vaccine effectiveness.

This extension signifies a crucial step forward in developing a safe and effective COVID-19 vaccine for adolescents and potentially younger children. The project’s success in adults with weakened immune systems further broadens its potential impact.

Read full press release here