Summary
The objective of this specific grant agreement (SGA) is to leverage co-funding from the European Commission to accelerate the development of vaccines against Rift Valley Fever (RVF), Chikungunya (CHIK) and Ebola virus diseases (EVD).
• RVF and CHIK vaccine development will be addressed by CEPI’s third Call for Proposals (CFP3), and it will structured through launching two sub-calls; CFP3i and CFP3ii. This SGA only relates to CFP3i, and has the following objectives:
a) For RVFV vaccines, to support clinical testing or activities enabling clinical Phase l/ll testing of the most advanced RVFV candidates, including identification of correlates of protection and their validation, which can facilitate future regulatory approval.
b) For CHIKV vaccines, to support the rapid progression of the most advanced clinical CHIKV vaccine candidates through mid-stage and late-stage clinical development, and to support activities enabling future efficacy testing, including identification of correlates of protection and their validation that can facilitate future regulatory approval.
The call will be launched January 2019 and will be open to all entities that meet the eligibility criteria and agree to CEPI’s award conditions – which are aligned with EU regulations.
EVD vaccine development will focus on addressing the remaining evidence gaps towards the licensure by FDA and/or EMA of the leading vaccine candidates, particularly on generating evidence of the protective efficacy of the vaccines in humans in the context of an outbreak. Towards this scope, and in order to take advantage of the research opportunities afforded by any large-scale Ebola outbreak, CEPI is expected to facilitate the rapid launch of clinical studies of the lead Ebola vaccine candidates. If feasible, the standard CfP mechanism will be used. However, in duly justified emergencies CEPI may award a grant without a call for proposals.
RVF and EVD are included among the WHO R&D Blueprint list of priority pathogens in 2018, while CHIKV was deemed to present a major public health risks for which “further research and development is needed” and “efforts in the interim to understand and mitigate them are encouraged”. Despite this stated urgency, action has been lacking – in part because low and middle-income countries are most at risk for future outbreaks and market incentives are lacking, both due to this and the inherently unpredictable nature and timing of future outbreaks. The current pipeline of candidates for these three pathogens does however bring a lot of promise; since there are quite a few mature candidates in the pipeline, targeted investments from CEPI and the EC could bring significant benefit and further strengthen and align the two entities’ existing priorities in vaccine development.
• RVF and CHIK vaccine development will be addressed by CEPI’s third Call for Proposals (CFP3), and it will structured through launching two sub-calls; CFP3i and CFP3ii. This SGA only relates to CFP3i, and has the following objectives:
a) For RVFV vaccines, to support clinical testing or activities enabling clinical Phase l/ll testing of the most advanced RVFV candidates, including identification of correlates of protection and their validation, which can facilitate future regulatory approval.
b) For CHIKV vaccines, to support the rapid progression of the most advanced clinical CHIKV vaccine candidates through mid-stage and late-stage clinical development, and to support activities enabling future efficacy testing, including identification of correlates of protection and their validation that can facilitate future regulatory approval.
The call will be launched January 2019 and will be open to all entities that meet the eligibility criteria and agree to CEPI’s award conditions – which are aligned with EU regulations.
EVD vaccine development will focus on addressing the remaining evidence gaps towards the licensure by FDA and/or EMA of the leading vaccine candidates, particularly on generating evidence of the protective efficacy of the vaccines in humans in the context of an outbreak. Towards this scope, and in order to take advantage of the research opportunities afforded by any large-scale Ebola outbreak, CEPI is expected to facilitate the rapid launch of clinical studies of the lead Ebola vaccine candidates. If feasible, the standard CfP mechanism will be used. However, in duly justified emergencies CEPI may award a grant without a call for proposals.
RVF and EVD are included among the WHO R&D Blueprint list of priority pathogens in 2018, while CHIKV was deemed to present a major public health risks for which “further research and development is needed” and “efforts in the interim to understand and mitigate them are encouraged”. Despite this stated urgency, action has been lacking – in part because low and middle-income countries are most at risk for future outbreaks and market incentives are lacking, both due to this and the inherently unpredictable nature and timing of future outbreaks. The current pipeline of candidates for these three pathogens does however bring a lot of promise; since there are quite a few mature candidates in the pipeline, targeted investments from CEPI and the EC could bring significant benefit and further strengthen and align the two entities’ existing priorities in vaccine development.
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More information & hyperlinks
| Web resources: | https://cordis.europa.eu/project/id/857934 |
| Start date: | 01-01-2019 |
| End date: | 29-02-2024 |
| Total budget - Public funding: | 51 428 572,00 Euro - 36 000 000,00 Euro |
Cordis data
Original description
The objective of this specific grant agreement (SGA) is to leverage co-funding from the European Commission to accelerate the development of vaccines against Rift Valley Fever (RVF), Chikungunya (CHIK) and Ebola virus diseases (EVD).• RVF and CHIK vaccine development will be addressed by CEPI’s third Call for Proposals (CFP3), and it will structured through launching two sub-calls; CFP3i and CFP3ii. This SGA only relates to CFP3i, and has the following objectives:
a) For RVFV vaccines, to support clinical testing or activities enabling clinical Phase l/ll testing of the most advanced RVFV candidates, including identification of correlates of protection and their validation, which can facilitate future regulatory approval.
b) For CHIKV vaccines, to support the rapid progression of the most advanced clinical CHIKV vaccine candidates through mid-stage and late-stage clinical development, and to support activities enabling future efficacy testing, including identification of correlates of protection and their validation that can facilitate future regulatory approval.
The call will be launched January 2019 and will be open to all entities that meet the eligibility criteria and agree to CEPI’s award conditions – which are aligned with EU regulations.
EVD vaccine development will focus on addressing the remaining evidence gaps towards the licensure by FDA and/or EMA of the leading vaccine candidates, particularly on generating evidence of the protective efficacy of the vaccines in humans in the context of an outbreak. Towards this scope, and in order to take advantage of the research opportunities afforded by any large-scale Ebola outbreak, CEPI is expected to facilitate the rapid launch of clinical studies of the lead Ebola vaccine candidates. If feasible, the standard CfP mechanism will be used. However, in duly justified emergencies CEPI may award a grant without a call for proposals.
RVF and EVD are included among the WHO R&D Blueprint list of priority pathogens in 2018, while CHIKV was deemed to present a major public health risks for which “further research and development is needed” and “efforts in the interim to understand and mitigate them are encouraged”. Despite this stated urgency, action has been lacking – in part because low and middle-income countries are most at risk for future outbreaks and market incentives are lacking, both due to this and the inherently unpredictable nature and timing of future outbreaks. The current pipeline of candidates for these three pathogens does however bring a lot of promise; since there are quite a few mature candidates in the pipeline, targeted investments from CEPI and the EC could bring significant benefit and further strengthen and align the two entities’ existing priorities in vaccine development.
Status
SIGNEDCall topic
SGA-SC1-CEPI-2019Update Date
26-10-2022
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