It was in month 14 of the project, almost halfway through its development, that the 13 partners in the consortium met for the second time in a hybrid meeting to discuss the progress of their work packages, make suggestions on the work of others, and discuss possible strategies to follow.
The entire consortium remains focused on working on the two planned clinical trials for a recombinant protein COVID-19 vaccine that is effective and safe for people with immunocompromised conditions, as well as for adolescent and paediatric participants.
After the first consortium meeting, following the launch meeting held in January 2022 (month 2 of the project), which was held in Girona where the partners were able to see first-hand the facilities of HIPRA, the coordinator of the project, this time the meeting was held at the Palau Macaya in Barcelona with IrsiCaixa as hosts.
RBDCOV project progress
In April 2022 the EMA started the rolling review of the HIPRA COVID-19 vaccine. The review and subsequent approval are the steps before its commercialisation. The protein-based vaccine is being developed by HIPRA as a booster vaccine for adults who have already been fully vaccinated with a different vaccine. The approval of HIPRA’s one is undoubtedly the stepping stone for the work of the RBDCOV project.
In May 2022 RBDCOV initiates the first Phase IIb clinical trial of HIPRA’s COVID-19 vaccine in people with immunocompromised conditions. This trial started after the Spanish Agency for Medicines and Health Products (AEMPS) authorised it on May 9. This clinical trial will determine whether an additional dose of HIPRA’s COVID-19 vaccine can generate an immune response in people living with immune system disorders, such as immunodeficiencies, or who are receiving immunosuppressant treatments.
In August 2022 the Health Emergency Preparedness and Response Authority (HERA) signs a Joint Procurement contract with HIPRA for COVID-19 vaccines. Here, RBDCOV represents a decisive step forward against COVID-19 by supplying its recombinant protein vaccine, a more competitive solution. This vaccine will also help to strengthen the European Health structure.
In January 2023 the HIPRA’s COVID-19 vaccine trial for people with immunocompromised conditions was launched in Turkey. The clinical trial started after the approval of the Turkish Medicines and Medical Devices Agency on October 28. This trial will involve 60 volunteers from three hospitals in Turkey: two in Ankara (Ankara University Medical Faculty Hospitals and Hacettepe University Medical Faculty Hospitals) and one in Istanbul (Koç University Hospital).
HIPRA’s COVID-19 vaccine
The COVID-19 vaccine developed by HIPRA is a bivalent, adjuvanted recombinant protein vaccine based on a receptor-binding domain (RBD) fusion heterodimer comprising the B.1.351 (beta) and B.1.1.7 (Alpha) variants of SARS-CoV-2.
Details about RBDCOV project
“RBD Dimer recombinant protein vaccine against SARSCoV2” (RBDCOV) is a Horizon Europe project led by the biotech pharmaceutical company HIPRA. It was launched on 1st December 2021, and its objective is to test the efficacy, tolerability, and safety of the HIPRA’s recombinant COVID-19 vaccine in children (including adolescents) and people with immunocompromised conditions.
To carry out this project, HIPRA works with an international consortium including companies and institutions from five European countries: Spain (IrsiCaixa, Vall D’Hebron Hospital, FLS, IDIBAPS, IDIBGI, Asphalion, Vinces Consulting, Zabala Innovation), United Kingdom (Veristat), Italy (Penta foundation), Germany (EATG), and Turkey (Metpharm).
The project envisages that the vaccine will be made accessible for vaccination campaigns worldwide thanks to its 2-8ºC storage temperature, which facilitates a longer-lasting shelf-life, transport, and distribution.
RBDCOV is one of 11 selected projects supporting clinical trials for a new vaccine that can go beyond Europe’s borders and create links with other European initiatives to effectively respond to 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 Programme (2021-2027), Europe’s largest research and innovation programme, and one of its priorities is to support urgent research on coronavirus and its variants.