One of the objectives of the RBDCOV project is to test whether the vaccine can reactivate or re-generate a protective immune response to SARS-CoV-2 in immunocompetent and immunosuppressed individuals
Accordingly, within the RBDCOV project a clinical trial in Turkey for HIPRA’s COVID-19 vaccine in people with immunocompromising conditions has recently started, aiming at determining whether an additional dose of HIPRA’s COVID-19 vaccine can generate an immune response in people living with immune system disorders or who are receiving immunosuppressive treatments.
This study will determine if the vaccine is able to reactivate or re-generate a sufficient immune response and increase the activity of the immune system (natural defences) to SARS-CoV-2. Additionally, the safety of this new vaccine will be assessed, and it will be studied if it can prolong the effect of earlier vaccination that the participants have already received.
Asphalion is proud regulatory partner of RBDCOV by carrying out the regulatory pathway throughout the whole project by seeking scientific advice for the RBDCOV clinical trials with the European regulatory authorities, preparing the required documents to support clinical trial applications and supporting the preparation of the eCTD registration dossier currently under rolling review, among other regulatory activities.
For more details about the project, have a look at the project´s website: RBDCOV Project Website
For further information, you can contact us at: [email protected]
