EBOVAC2 is organised into six workpackages (WP), or groups of activities, in order to reach its objectives.
WP1 will oversee the activities of all work packages and interact with the overall EBOLA+ programme governance. WP2 will conduct the clinical trials, enroll volunteers, collect blood samples, and record clinical trial data. The collected blood samples will be sent to the laboratories participating in WP3 who will be in charge of the immunogenicity measurements of the trial samples. WP4 will be in close interaction with WP2 and WP3 to translate results from clinical to NHP research and vice versa. WP5 will manage the upload of EBOVAC2 data into the data repository. WP6 will be in charge of disseminating the information relative to the overall project (WP1) as well as milestones and results of each work package.
WP1: Project coordination and management
The objectives of this WP are three-fold:
- At the strategic level, to ensure that the project reaches its objectives and expected impacts;
- At the managerial level, to put in place the procedures and tools needed to ensure that the project progresses in conformity with the work plan and produces timely and quality results as well as overseeing conformity of all activities to IMI JU rules and the Consortium agreement;
- At the administrative level, to organise project meetings, prepare project reports, manage the project budget and payments.
WP2: Clinical core
This WP aims to confirm the robustness of safety and immunogenicity of the Ad26.ZEBOV/MVA-BN-Filo Heterologous 2-dose prophylactic vaccination regimen obtained in Phase 1 trials through the conduct of Phase 2 trials in European and African populations.
WP3: Immune monitoring (Phase II trial)
The objectives of this WP are to analyse the immunogenicity of the Ad26.ZEBOV/MVA-BN-Filo Heterologous two-dose prophylactic vaccination regimen in Phase 2 trials conducted in European and African populations through:
- Evaluation of the immune response to the dose 1/dose 2 based on protocol-defined endpoints (core immuno assessment including T cell and antibody responses);
- Extensive characterization of the immune response to the vaccine regimen (cellular functionality, neutralisation of living virus);
- Description of the immune signature and to better understand the mechanism of the vaccine regimens effect through gene expression monitoring; Integrative statistical analysis of the gene expression and functional assays to understand and predict the effect of the vaccine regimen on the immune system.
WP4: Translational studies to link vaccine elicited immune responses in humans to protection from Ebola in vaccinated non-human primates (NHP).
The objective of this WP is to carry out translational studies to link vaccine elicited immune responses in humans to protection from Ebola in vaccinated non-human primates.
WP5: Data management and integration
The primary objective of the data management and integration work package is to load EBOVAC2 data to the INFOCENTRE (joint Ebola+ program data collection platform) and conduct statistical analysis on the data available. This WP will be carried out in compliance with the consortium Information Governance Model and project agreement.
WP6: Communication and Capacity Building
The objectives of this WP are to develop and implement a communication plan involving all relevant stakeholders and beneficiaries of EBOVAC2. In addition, best practices and procedures for performing clinical trials will be developed and medical and non-medical laboratory staff will be trained on heterologous 2-dose prophylactic vaccine management.
Leader: Inserm Transfert
- Data to demonstrate the safety, immunogenicity and, potentially, the efficacy of the heterologous 2-dose prophylactic vaccine regimen in prevent Ebola virus disease
- Reduced disease burden: if proved effective the vaccine will also potentially contribute to preventing future epidemics, saving lives and reducing suffering and damage to health systems and wider society in affected countries
- Capacity development in affected countries to ensure preparedness for future outbreaks