Work packages

WP 1

Manufacturing and tuning of COVID-19 recombinant protein vaccines ​

WP1 will manufacture all the required GMP protein recombinant-based vaccines against Wuhan variant to perform the clinical trial phase I/II in paediatric population and to tune to other variants.

WP 2

Clinical trial management and monitoring

WP2 will establish close coordination and monitoring to assure that protocol and clinical research rules are properly followed; will ensure the Standard operating Procedures; 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 to monitor the quality of the clinical trial activities.

WP 3

New emerging variant vaccine trial phase I/II in children and adolescents

WP3 will perform a multi-center, observer-blinder dose escalation phase I and II studies in paediatric population; will assess the immunogenicity and safety of the vaccine against Wuhan variant; will define the recommended dose of according to the age; and will prevent COVID-19 infection of Wuhan variant.

WP 4

New emerging variant vaccine clinical trial phase III

WP4 will perform a multi-center, double-blinded phase II studies in adult participants; will assess the safety, tolerability and immunogenicity of the new RBD protein recombinant COVID-19 vaccine against the South African and UK variants; and will prevent the COVID-19 infection of Wuhan and new variants.

WP 5

Immune monitoring and clinical data analysis

WP5 will characterize vaccine immunogenicity from 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.

WP 6

Regulatory pathways

WP6 will seek scientific advice for the RBDCOV clinical trials with the European regulatory authorities; will prepare all the required document to support the clinical trial application according to the current legislation; and, will affectively support the clinical trial implementation fulfilling the legal requirements.

WP 7

Exploitation & Marketing strategy

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.

WP 8

Dissemination and communication

WP8 will communicate and disseminate the state of results of RBDCOV project; will participate in major European and international events and conferences; will contact different initiatives with whom to collaborate; and, will impulse networking with the different agencies related with the approval of the vaccines.

WP 9

Community engagement

WP9 will promote and ensure the engagement and feedback of participants of the different clinical trials by creating a Community Advisory Panel; will ensure that protocol sections are built considering patients needs and preferences; will assess the expectations of the participants and anticipate any concern coming from the; and, will ensure that the information delivered to participants involved in the clinical trial is accessible, complete, transparent and comprehensible.

WP 10

Scientific Coordination and project management

WP10 will provide overall scientific direction and to drive the progress of the project, steering efforts of the 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.

WP 11

Ethics requirements

WP11 will ensure compliance with the ‘ethics requirements’ set out in this work package.