RBDCOV: Working on an Inclusive COVID-19 Clinical Trial

Since the end of 2021, EATG has been a partner in RBDCOV, a pioneer project aiming to test the efficacy, tolerability and safety of a new recombinant COVID-19 vaccine with children, adolescents and immunocompromised individuals.

In this project, EATG has been working in close cooperation with the rest of the partners of the consortium to ensure the adequate representation of our community.

But where is the project now? What has been achieved in the past months?

The project was conceived to run two different clinical trials to test its vaccine with two different target groups: people with compromised immune systems and children (including adolescents) in two different countries: Spain and Turkey. To this day, the Spanish trial recruitment has been completed and counted with the involvement of 232 participants. The trial taking place in Turkey will start its recruitment process at the end of this month and will be focused on participants with renal transplants and receiving dialysis.

Meanwhile, EATG continues to lead the way in community engagement and advises on communication related aspects of the trials. Together with the help of the 8 EATG members [Alain Volny-Anne, Bogdan Hadarag, Brian West, Deniz Uyanik, Joan Tallada, Maka Gogia, Maryan Said and Siegfried Schwarze – our Community Advisory Panel (CAP)], the team has provided input on several communication and project materials, such as the website, the adult trial protocol, the information consent form and the participant info sheets. Furthermore, we have also focused our efforts on developing a clear and user – friendly trial FAQs and glossary section to make sure that the information is inclusive and accessible to everyone.

It is of the utmost importance that all our communications are clear, accurate and understandable both for participants, our community and for the general population. That is why EATG staff and the CAP are working side by side with project partners to improve the communication and community engagement actions of the RDBCOV project. As representatives of our community, we want our voices heard and represented.

So… what’s next?

The next steps for the project will include the start of the adult clinical trial in Turkey, finalising the protocol for the children and adolescents trial, and the approval of the by EMA.

On EATG’s side, we will continue working closely with the CAP and provide feedback on upcoming project videos, online campaigns and news articles in order to include the community’s perspective throughout the project. EATG will soon be planning and conducting research to understand the psychosocial aspects of participating in a vaccine trial.

Finally, it is key to remember why EATG believes in the importance of participating in projects such as RDBCOV, as people living with HIV are almost always excluded from non-HIV clinical trials.

The inclusion and exclusion criteria for the participation of people living with HIV in non-HIV clinical research has been an ongoing discussion, exacerbated by recent COVID-19 vaccination trials, which initially excluded people living with HIV. That is why EATG advocates for the development and implementation of inclusive clinical trials research guidelines that would improve the health outcomes for people living with HIV. In this regard, the participation of EATG in the RDBCOV aims to achieve this goal: the inclusion of people living with HIV in non-HIV clinical trials with the aim of setting a precedent for the future.

If you are interested in reading more about why people living with HIV must be included in non-HIV clinical trials, you can read our position paper outlining our rationale . Moreover, more information about the RDBCOV project can be found here.