Periodic Reporting for period 4 - ECRC (Developing a diverse portfolio of vaccine candidates for Rift Valley Fever, Chikungunya and Ebola)
Período documentado: 2022-09-01 hasta 2024-02-29
CEPI is an international organisation whose mission is to accelerate the development of vaccines against emerging infectious diseases and enable equitable access to these vaccines for affected populations during outbreaks. Having previously invested in vaccine development efforts against Nipah, Lassa and MERS and platform technologies, CEPI was in late 2018 looking into expanding its number of priority diseases to include Rift Valley fever (RVF) and Chikungunya (CHIK).
It was CEPI’s Scientific Advisory Committee that advised these two diseases to be prioritised. The decision to fund the development of vaccines against RVF and CHIKV was based on the risk of outbreaks, feasibility of vaccine development and the potential public health impact of vaccines against these diseases. While vaccines against both viruses appear to be technically feasible, the commercial prospects for vaccines against RVF are non-existent and for CHIK, uncertain at best. RVF was included among the WHO R&D Blueprint list of priority diseases in 2018, while CHIK disease was deemed to present major public health risks for which “further research and development is needed” and would require “efforts in the interim to understand and mitigate the public health risks”. Both RVF and CHIK cause regular outbreaks and continue to present a major public health threat in LMICs.
Co-funding from the EU’s Horizon 2020 enabled CEPI to launch a Call for Proposals for CHIKV and RVF in January 2019. Additionally, the same funding stream supported CEPI’s response to the ongoing Ebola outbreak where EC funding will be channelled towards supporting the clinical development of a second vaccine candidate.
Objectives under this grant:
Rift Valley Fever (RVF): To support activities enabling clinical Phase I/II testing of the most advanced RVF vaccine candidates, including identification of correlates of protection and their validation, which can facilitate future regulatory approval.
Chikungunya (CHIK): To support rapid progression of the most advanced clinical vaccine candidates for CHIK through mid/stage and late-stage clinical development, and to support activities enabling future efficacy testing, including identification of correlates of protection and their validations that can facilitate future regulatory approval.
Ebola (EVD): To address the remaining evidence gaps towards the licensure by FDA and or EMA for the leading vaccine candidates. To generate evidence of the protective efficacy of the vaccines in the context of an outbreak by facilitating the rapid launch of clinical studies of the lead Ebola vaccine candidates.
EC co-funding has enabled the development of vaccines against diseases that are of particular concern to low and middle- income countries and will greatly help to prevent or contain associated epidemics. The EC-CEPI co-investment therefore contributes to the EU’s development policy by addressing some of the root causes of the detrimental effects on human lives and economic losses due to RVF and CHIK. This also aligns with the UN’s Sustainable Development Goals (SDGs). By helping to strengthen the capacity for reduction and management of national and global health risks, CEPI's investments in priority diseases will, with the EU’s support, help contribute to SDG3 (“Ensure healthy lives and promote wellbeing for all at all ages”). The same is true for SDG8 (“Promote inclusive and sustainable economic growth”): stopping outbreaks before they cause widespread mortality and disruption, will avoid potential negative effects on economic growth. CEPI’s inclusive and collaborative approach to activities, also “encourage(s) and promote(s) effective public, public-private and civil society partnerships, building on the experience and resourcing strategies of partnerships”, thus also aligning with SDG17 (“Strengthen the means of implementation and revitalize the global partnership for sustainable development”)
Please see cepi.net for further details about the progress of the most recent call relating to Chikungunya and Rift Valley Fever (termed “CfP3i).
It was CEPI’s Scientific Advisory Committee that advised these two diseases to be prioritised. The decision to fund the development of vaccines against RVF and CHIKV was based on the risk of outbreaks, feasibility of vaccine development and the potential public health impact of vaccines against these diseases. While vaccines against both viruses appear to be technically feasible, the commercial prospects for vaccines against RVF are non-existent and for CHIK, uncertain at best. RVF was included among the WHO R&D Blueprint list of priority diseases in 2018, while CHIK disease was deemed to present major public health risks for which “further research and development is needed” and would require “efforts in the interim to understand and mitigate the public health risks”. Both RVF and CHIK cause regular outbreaks and continue to present a major public health threat in LMICs.
Co-funding from the EU’s Horizon 2020 enabled CEPI to launch a Call for Proposals for CHIKV and RVF in January 2019. Additionally, the same funding stream supported CEPI’s response to the ongoing Ebola outbreak where EC funding will be channelled towards supporting the clinical development of a second vaccine candidate.
Objectives under this grant:
Rift Valley Fever (RVF): To support activities enabling clinical Phase I/II testing of the most advanced RVF vaccine candidates, including identification of correlates of protection and their validation, which can facilitate future regulatory approval.
Chikungunya (CHIK): To support rapid progression of the most advanced clinical vaccine candidates for CHIK through mid/stage and late-stage clinical development, and to support activities enabling future efficacy testing, including identification of correlates of protection and their validations that can facilitate future regulatory approval.
Ebola (EVD): To address the remaining evidence gaps towards the licensure by FDA and or EMA for the leading vaccine candidates. To generate evidence of the protective efficacy of the vaccines in the context of an outbreak by facilitating the rapid launch of clinical studies of the lead Ebola vaccine candidates.
EC co-funding has enabled the development of vaccines against diseases that are of particular concern to low and middle- income countries and will greatly help to prevent or contain associated epidemics. The EC-CEPI co-investment therefore contributes to the EU’s development policy by addressing some of the root causes of the detrimental effects on human lives and economic losses due to RVF and CHIK. This also aligns with the UN’s Sustainable Development Goals (SDGs). By helping to strengthen the capacity for reduction and management of national and global health risks, CEPI's investments in priority diseases will, with the EU’s support, help contribute to SDG3 (“Ensure healthy lives and promote wellbeing for all at all ages”). The same is true for SDG8 (“Promote inclusive and sustainable economic growth”): stopping outbreaks before they cause widespread mortality and disruption, will avoid potential negative effects on economic growth. CEPI’s inclusive and collaborative approach to activities, also “encourage(s) and promote(s) effective public, public-private and civil society partnerships, building on the experience and resourcing strategies of partnerships”, thus also aligning with SDG17 (“Strengthen the means of implementation and revitalize the global partnership for sustainable development”)
Please see cepi.net for further details about the progress of the most recent call relating to Chikungunya and Rift Valley Fever (termed “CfP3i).
The Call for Proposals was successfully published January 7 2019, closing 60 days later. Following due diligence and contract negotiations, CEPI entered into partnership agreements with five applicants.
EC funds were also directed towards the clinical development of a second vaccine candidate against Ebola for use in the continuing outbreak in the DRC.
EC funds were also directed towards the clinical development of a second vaccine candidate against Ebola for use in the continuing outbreak in the DRC.
Four of the five entities that have been awarded funds are all progressing according to plan. One awardee funding was discontinued due to the significant additional cost and associated timelines.
Funding for CHIK is directed towards advanced clinical development in which the Awardees will work towards Phase III clinical trials with a view to final licensure. In a significant achievement, the Valneva IXCHIQ product (VLA1553) product was licensed by the US FDA in late 2023, making it the first ever licensed CHIK vaccine.
Of the RVF projects, Colorado State University (one of the two RVF projects) completed this grant in June 2023 establishing a solid pre-clinical data package with evaluation of candidate safety, immunogenicity and protection in multiple animal models including NHPs. Despite the significant impact of COVID-19 with the challenges and restrictions faced by the team which led to delays, the team successfully delivered a comprehensive Tech Transfer report to allow for the project to be continued with no further delays if additional funding was secured (successful application to RIFTVAX). GMP production of the product was not feasible within the ECRC grant period and this allowed CEPI to re-evaluate the project prior to endorsing further resources.
During this time period of this grant, Wageningen (The second RVF project) has also established a solid pre-clinical data package, again establishing safety, immunogenicity and protection in multiple animal species including NHPs, along with the completion of a First in human Phase I clinical study in June 2023 (date of last participant last visit). Some issues during the manufacturing of the material to be used for the toxicology and Phase I clinical trials were overcome, however coupled with the impact of COVID-19, this led to a delay of the project overall. The project officially ended in December 2023. The resulting data package led to a successful application for further funding for later stage development within the RIFTVAX programme.
Funding for CHIK is directed towards advanced clinical development in which the Awardees will work towards Phase III clinical trials with a view to final licensure. In a significant achievement, the Valneva IXCHIQ product (VLA1553) product was licensed by the US FDA in late 2023, making it the first ever licensed CHIK vaccine.
Of the RVF projects, Colorado State University (one of the two RVF projects) completed this grant in June 2023 establishing a solid pre-clinical data package with evaluation of candidate safety, immunogenicity and protection in multiple animal models including NHPs. Despite the significant impact of COVID-19 with the challenges and restrictions faced by the team which led to delays, the team successfully delivered a comprehensive Tech Transfer report to allow for the project to be continued with no further delays if additional funding was secured (successful application to RIFTVAX). GMP production of the product was not feasible within the ECRC grant period and this allowed CEPI to re-evaluate the project prior to endorsing further resources.
During this time period of this grant, Wageningen (The second RVF project) has also established a solid pre-clinical data package, again establishing safety, immunogenicity and protection in multiple animal species including NHPs, along with the completion of a First in human Phase I clinical study in June 2023 (date of last participant last visit). Some issues during the manufacturing of the material to be used for the toxicology and Phase I clinical trials were overcome, however coupled with the impact of COVID-19, this led to a delay of the project overall. The project officially ended in December 2023. The resulting data package led to a successful application for further funding for later stage development within the RIFTVAX programme.