From routine clinical development to emergency evidence generation readiness
Substantial investments in advanced stage clinical development of vaccines in endemic areas of the global South are usually not leveraged to sustain capacity at clinical research entities. As a result, there is still a lack of site readiness in those areas where the risk for future epidemics is the highest.
To prevent future outbreaks from realising their pandemic potential, the world needs to up the pace in the race against new and re-emerging viruses. If it takes just 100 days to make a safe and effective vaccine against any viral pandemic threat, we could potentially contain outbreaks before they spiral out of control. This goal is known as the 100 Days Mission. It is embraced by leaders of the G7 and G20 and is widely recognized as an ambitious global collaborative effort.
To support both advanced-stage clinical development of CEPI’s portfolio vaccines against priority diseases and the 100 Days Mission, CEPI has launched the Research Preparedness Program.
How does it work?
The objective of the Research Preparedness Program is to leverage investments for advanced-stage clinical development of CEPI's portfolio vaccines and support countries in key regions to generate emergency evidence in future outbreaks. Designed as a multi-regional approach tailored to the specific needs of clinical research ecosystems in certain regions and countries, the Research Preparedness Program will initially focus on those geographies where priority diseases are most prevalent.
The program is facilitated by Technical Coordinating Partners (TCPs) who are onboarded by CEPI through a rigorous competitive process (Request for Proposals). Eligibility criteria for TCPs include an excellent track record of previous work related to clinical vaccine trials and research in the respective region, a deep understanding of the regional clinical research ecosystem and strong evidence for successful establishment of self-sustained multi-national partnerships.
Approach
To account for both routine clinical development of vaccines in inter-epidemic periods and evidence generation in emergencies, the program is split into two tracks that mutually inform and complement each other. Together with local and regional partners, regional and supra-regional public health agencies, the TCP develops strategies to strengthen existing capacity for clinical research in order to serve both tracks. While work under Track A focuses on specific priority diseases for the region, the approach for Track B is broader and disease-agnostic.
Supporting self-sustained clinical research entities through open access approach
While investments under Track A aim to directly support the advanced-stage clinical development of CEPI’s portfolio vaccines, one of the most important goals of the program is to identify ways with local partners to sustain the capacity and knowledge beyond individual clinical trials. To ensure local partners take ownership and therewith lay the foundation for continued institutional funding by national governments, CEPI engages with a broad variety of stakeholders in the target regions and request their guidance about how CEPI and other funders can provide meaningful funding for capacity strengthening. CEPI partners with regional and supra-regional public health agencies (e.g. WAHO and Africa CDC) to make sure that Research Preparedness activities are aligned with their individual roadmaps for the region and continent.
One of the corner stones of CEPI’s Research Preparedness Program is a non-exclusive / open-access approach. This entails a variety of important aspects:
all capacity and knowledge that is strengthened or built at the country- or site-level is meant to serve not only CEPI-funded projects but is open to everyone
many components of the program (e.g. data resulting from landscape assessments, sustainability assessment frameworks, etc.) will be made available on open-access platforms
CEPI aims to support platform trials where multiple vaccine candidates will be incorporated in trials at selected clinical trial sites
Finally, CEPI will support entities in the target regions to develop their own business models to support their independence from project-specific funding.
Key principles of the program
Regional partners
Together with the TCP regional partners with a specific regional footprint (CROs, regional clinical trial networks, etc.) will implement strategies on the ground e.g. capacity development at clinical trial sites, etc.
Local/country partners and public health agencies
Local/country partners are key for the successful conduct of trials in the country and will be added to the consortium and onboarded by the TCP. These are academic institutions (global North and South), clinical trial sites, public health agencies in the respective countries, governments, national health authorities (Public health agencies like e.g. Africa CDC (African Union), Nigeria CDC and WHO as well as regional political unions like ECOWAS).
Other
TRANSVAC Academy aims to bridge the knowledge gap in vaccine research and development by offering training modules covering a wide range of subjects, from grant management to advanced process development. TRANSVAC Academy is committed to ensuring these trainings remain not only high-quality but broadly accessible. https://www.transvac.org/transvacacademy-training-courses
Registration and travel grants for a number of applicants from low-and middle-income countries (LMICs) are generously sponsored by CEPI. LMIC applicants can apply for seats through the above TRANSVAC link.
Research Preparedness in East and Central Africa (RPECA)
Research Preparedness RfPs
The Request for Proposals (RfP) for Research Preparedness for East and Central Africa is now closed
Events and Publications
Dakar Ecosystem Engagement Workshop - June 2024
This workshop focused on enhancing the region's ability to conduct rapid clinical trials during outbreaks e.g. Lassa fever. It brought together 54 participants from 9 West African countries including representatives from government, research institutes, and experts.
Key discussions centered around improving political commitment, governance structures, regulatory frameworks, and clinical trial infrastructure. The workshop identified rapid site activation and community engagement as critical factors for successful evidence generation during future outbreaks. Participants also stressed the importance of regional collaboration, including harmonizing ethical review processes, strengthening cross-border coordination, and developing a regional emergency Research Preparedness plan.
A second workshop was held 30 Oct - 1 Nov in Accra, Ghana to further develop the findings and ideas generated in Dakar in June. Co-hosted by Africa CDC, CEPI, IVI, MRCG, and WAHO it consulted with a wider range of stakeholders from across West Africa, to get feedback on the vision of a regional ecosystem for Research Preparedness, and to develop an actionable engagement plan for the future.
Addis Ababa Continental Research Prioritization Framework Workshop – Nov 2024
The Continental Research Prioritization Framework Workshop was held from November 21-23, 2024 in Addis Ababa, Ethiopia. It was convened by Africa CDC and Heads of Research; Heads of National Ethics Committee from 47 African Union (AU) Member States, as well as multiple other partners attended. The key objectives included the validation of the continental health research prioritization and African-centered ethics frameworks, as well as the mapping tool for health research capacity and capability assessment of research centers and sites in AU Member States.
