The European & Developing Countries Clinical Trials Partnership
(EDCTP) aims to accelerate the development of new or improved drugs,
vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis
and malaria as well as other poverty-related and neglected infectious
diseases in sub-Saharan Africa, with a focus on phase II and III
clinical trials.
The purpose of this call is to support large-scale collaborative
projects which include one or more clinical trials (phase I to IV)
aiming to accelerate the clinical development of new vaccines
(preventive or therapeutic) against one of the PRDs. Applications must
include at least one clinical trial which will be carried out in
sub-Saharan Africa to test the safety, immunogenicity and/or efficacy of
the vaccine(s).
Background
Vaccines have contributed enormously to the successful control and elimination of many diseases. To date, few vaccines have been developed for controlling poverty-related diseases (PRDs)(1). In recent years, several candidate vaccines against PRDs have entered clinical development and there is an urgent need to fast track their development. The aim is to increase the number of promising vaccines targeted for use especially in Africa.
Vaccines have contributed enormously to the successful control and elimination of many diseases. To date, few vaccines have been developed for controlling poverty-related diseases (PRDs)(1). In recent years, several candidate vaccines against PRDs have entered clinical development and there is an urgent need to fast track their development. The aim is to increase the number of promising vaccines targeted for use especially in Africa.
Scope
Applications are invited for large-scale collaborative projects which include one or more clinical trials (phase I to IV) aiming to accelerate the clinical development of new vaccines (preventive or therapeutic) against one of the PRDs. Applications must include at least one clinical trial which will be carried out in sub-Saharan Africa to test the safety, immunogenicity and/or efficacy of the vaccine(s).
Applications are invited for large-scale collaborative projects which include one or more clinical trials (phase I to IV) aiming to accelerate the clinical development of new vaccines (preventive or therapeutic) against one of the PRDs. Applications must include at least one clinical trial which will be carried out in sub-Saharan Africa to test the safety, immunogenicity and/or efficacy of the vaccine(s).
Target product profiles, particularly indication, target populations,
safety and/or efficacy should be included. Additionally, a clear list
of product development milestones including specific go/no-go criteria
for the implementation of the proposed clinical trial must be included.
Projects may include detailed analyses of host responses to advance
the understanding of mechanisms of reactogenicity (safety),
immunogenicity and/or efficacy. Projects should incorporate activities
to enhance the capacity of existing trial sites and/or develop new trial
sites in sub-Saharan Africa for conduct of vaccine trials.
Applications that leverage support from other funders, particularly
the pharmaceutical industry and Product Development Partnerships, are
encouraged.
EDCTP considers that proposals for actions of between 36 and 60
months duration would allow this specific challenge to be addressed
appropriately. Nonetheless, this does not preclude submission and
selection of proposals for actions of a different duration.
Expected impact
Actions supported under this Call for Proposal should advance the development of promising candidate vaccines for PRDs moving towards regulatory licensure. The actions should also contribute towards a better understanding of the mechanisms of reactogenicity (safety), immunogenicity and/or efficacy profile of the vaccine candidate(s). The projects will build capacity for the evaluation of different vaccines against PRDs in sub-Saharan Africa.
Actions supported under this Call for Proposal should advance the development of promising candidate vaccines for PRDs moving towards regulatory licensure. The actions should also contribute towards a better understanding of the mechanisms of reactogenicity (safety), immunogenicity and/or efficacy profile of the vaccine candidate(s). The projects will build capacity for the evaluation of different vaccines against PRDs in sub-Saharan Africa.
Eligibility
Consortia comprising a minimum of three independent legal entities are eligible to apply. Two of the legal entities must be established in two different European Participating States(2) of the EDCTP Association and one of the legal entities must be established in a sub-Saharan African country(3).All three legal entities shall be independent of each other.
Consortia comprising a minimum of three independent legal entities are eligible to apply. Two of the legal entities must be established in two different European Participating States(2) of the EDCTP Association and one of the legal entities must be established in a sub-Saharan African country(3).All three legal entities shall be independent of each other.
‘Sole participants’ formed by several legal entities (e.g. European
Research Infrastructure Consortia, European Groupings of Territorial
Cooperation, central purchasing bodies) are eligible if the
above-mentioned minimum conditions are satisfied by the legal entities
forming together the sole participant.
