WP1 will manufacture all the required GMP protein recombinant-based vaccines in order to perform the phase IIb/III clinical trials in the paediatric population and the population of people with immunocompromising conditions and will adapt the vaccines to several other COVID-19 variants.
WP2 will establish close coordination and monitoring to assure that protocol and clinical research principles and standard operating procedures are properly followed; will guarantee on-time submission of the corresponding information to the competent authorities and ethical committees; will perform risk-management study analysis and periodical monitoring to minimise protocol deviations; and will enforce the appropriate quality assurance system application of the clinical trial activities.
WP3 will perform a multi-centre, open-label phase IIb study in the paediatric population; will assess the immunogenicity and safety of the vaccine against several variants.
WP4 will perform a multi-centre, open-label phase IIb/III study in adult participants with immunocompromising conditions; will assess the safety, tolerability and immunogenicity of the new RBD protein recombinant COVID-19 vaccine against several variants.
WP5 will characterise vaccine immunogenicity from the WP3 and WP4 clinical trials; will delineate the mechanistic insights of SARS-CoV-2 variant recognition by B and T cells and will identify host gene expression profiles and antigen receptor repertoires associated with potent and broad cross-reactive immunity.
WP6 will seek scientific advice for the RBDCOV clinical trials with the European regulatory authorities; will prepare all the required documents to support the clinical trial application according to the current legislation; and will affectively support the clinical trial implementation fulfilling the legal requirements.
WP7 will build a pricing and reimbursement strategy to market RBDCOV vaccine; will establish and execute a protection strategy of the results towards an exploitation; and will develop a business plan to ensure the exploitation of the different RBDCOV results.
WP8 will communicate and disseminate the results of the RBDCOV project; will participate in major European and international events and conferences; will contact different initiatives with whom to collaborate; and will network with the different agencies related with the approval of the vaccines.
WP9 will promote and ensure the engagement and feedback of the patient community of the clinical trials by creating a Community Advisory Panel; will ensure that protocol sections are built considering participant and community needs and preferences; will assess psychosocial factors of participation in a COVID-19 vaccine trial to ensure that participant experience is documented; and will ensure that the information delivered to participants involved in the clinical trial is accessible, complete and transparent. In addition, WP9 will provide regular support in the activities of WP8 to ensure communications are community friendly.
WP10 will provide overall scientific direction and will drive the progress of the project with partners, will provide a unified scientific, technological and strategic view throughout the project implementation; will continuously assess the degree of fulfilment of the project’s objectives; will ensure that the project is not hampered by logistical and ethical problems; and will ensure that the project is appropriately managed according to the work plan.
WP11 will ensure compliance with the ‘ethics requirements’ set out in this work package.
