Lassa virus (LASV) has been added to the WHO R&D Blueprint list of diseases for which there is an urgent need for accelerated research and development, considering the disease’s potential to cause a public health emergency, and given the absence of efficacious drugs and/or vaccines.
The purpose of this call for proposals is to support distinct clinical research activities which are part of efforts to prepare and conduct a large-scale clinical trial that has the potential to achieve proof of concept and/or the demonstration of pivotal efficacy of novel candidate vaccines against LASV.
Applications are invited for large-scale collaborative projects which include one or more clinical trials (phase II to III) aiming to accelerate the clinical development of Lassa candidate vaccines. Applications must include a minimum of one clinical trial to be conducted in affected countries in sub-Saharan Africa to test the safety, immunogenicity and/or efficacy of a candidate vaccine. Proposals that include phase III trials are particularly encouraged.
Projects should incorporate activities to enhance the capacity of existing trial sites and/or develop new trial sites in affected countries in sub-Saharan Africa for the conduct of vaccine trials. These activities could include observational (site set-up) studies, retrospective evaluation of available epidemiological data and prospective cohort studies to define incidence and case definitions for subsequent efficacy trials. Strengthening of laboratory testing capacity for case ascertainment and product evaluation is considered in scope when necessary for supporting the proposed clinical trial(s). This could include the evaluation of newly developed or newly standardized diagnostic assays for LASV and immunological read-outs for vaccine performance as well as the setup or strengthening of regional or in-country biobanks for sample storage and archiving.
These activities would ideally build on and leverage existing or developing networks of excellence or ongoing capacity development of researchers, institutions, and sites, including existing national or regional biobanking facilities, in sub-Saharan Africa, to conduct clinical trials and related research, including observational studies. The inclusion of plans to involve public health authorities in disease-endemic countries is also encouraged.
Supporting information on the composition and scale, as well as on the management structures and procedures of the large-scale clinical trial must be presented to enable assessment of their appropriateness.
The EDCTP Association and CEPI consider that proposals for actions of between 36 and 60 months duration would allow this specific challenge to be addressed appropriately. When the EDCTP Association and CEPI deem participation of the entity essential for carrying out the action, legal entities from anywhere in the world will be eligible for funding through this call for proposals.
Actions supported under this call for proposal should advance the development of promising LASV candidate vaccines moving towards regulatory licensure. The actions should also contribute towards a better understanding of the mechanisms of the reactogenicity (safety), immunogenicity and efficacy profile of the LASV candidate vaccine(s) and build capacity for the evaluation of vaccines against LASV and other EIDs in sub-Saharan Africa.
Capacity-enhancing activities should contribute to strengthening regional, national, institutional and individual capacities to conduct clinical trials for product evaluation according to ICH-GCP standards and generate data to inform trial design and appropriate endpoints.
For information and details on how to apply, please visit the EDCTP website.
Close date: 7 April 2020