Periodic Reporting for period 5 - CCHFVaccine (Crimean-Congo Haemorrhagic Fever Vaccine)
Período documentado: 2023-01-01 hasta 2023-12-31
Crimean-Congo hemorrhagic fever (CCHF) is an emerging tick borne viral disease widely distributed across Africa, Southern Europe, the Middle East and Asia. It is considered one of the major emerging disease threats spreading to, and also within, the European Region following increasing circulation of its main vector, ticks of the genus Hyalomma. The virus is primarily transmitted via tick bites, but also through handling of infected livestock or treatment of CCHFV infected patients. In humans, CCHFV cause febrile-illness, which in some cases are mild, but in other cause sever diseases with hemorrhagic manifestations. The fatality rate range between 5-30% and currently there are no approved treatment or vaccine against CCHF. The extensive spread of the virus, mode of transmission and severity of the disease make CCHF a significant threat to the global health and the World Health Organization (WHO) recently put CCHFV on its blue print list to emphasis the importance of developing antivirals and/or a vaccine (project https://www.who.int/blueprint/).
The major goal of CCHFVaccine project is to develop a vaccine candidate, which can be specifically used to protect high risks groups in endemic area such as health care workers, farmers, slaughter houses, tourists, and others. This vaccine will not only protect these at-risk populations but will also contribute to limit the transmission of the virus in endemic regions and neighboring areas. CCHFVaccine project will build a unique biobank, which will be used to define biomarkers and also signature for protective immunity against this disease.
During the fifth reporting period, we achieved several milestones. Utilizing the assays we developed and the established bio bank from the CCHFVaccine project, we conducted investigations into humoral and T-cell immunity in CCHF patients. Furthermore, we successfully completed the GLP production of the vaccine candidate, finalized the toxicity study in animals, engaged with the EMA scientific advisory committee, and submitted the application to the EMA to initiate Clinical Phase I trials. Our objectives remain consistent and a safety trial for the vaccine is scheduled to take place in Sweden in 2024.
The major goal of CCHFVaccine project is to develop a vaccine candidate, which can be specifically used to protect high risks groups in endemic area such as health care workers, farmers, slaughter houses, tourists, and others. This vaccine will not only protect these at-risk populations but will also contribute to limit the transmission of the virus in endemic regions and neighboring areas. CCHFVaccine project will build a unique biobank, which will be used to define biomarkers and also signature for protective immunity against this disease.
During the fifth reporting period, we achieved several milestones. Utilizing the assays we developed and the established bio bank from the CCHFVaccine project, we conducted investigations into humoral and T-cell immunity in CCHF patients. Furthermore, we successfully completed the GLP production of the vaccine candidate, finalized the toxicity study in animals, engaged with the EMA scientific advisory committee, and submitted the application to the EMA to initiate Clinical Phase I trials. Our objectives remain consistent and a safety trial for the vaccine is scheduled to take place in Sweden in 2024.
In the fifth reporting period (RP5), we successfully established a DIVA strategy, allowing for the differentiation between infected and vaccinated animals. A longevity study conducted on mice revealed that immune responses to our vaccine candidate persisted for up to four months post-vaccination. Furthermore, a small-scale vaccination and durability study commenced, assessing the mRNA vaccine in sheep. Initial results demonstrated a robust immune response in sheep lasting at least four months, and the study is currently ongoing. Additionally, our research on non-human primates exhibited significant protection against CCHFV, highlighting the crucial role of the N plasmid in providing protection.
Furthermore, we explored immune responses in various categories of CCHF patients using our developed assays and biobank. Additionally, progress has been made in delineating an immune signature indicative of protective immunity by aggregating data related to pro-inflammatory and omics responses observed in patients with Crimean-Congo Hemorrhagic Fever (CCHF).
Moreover, GMP manufacturing has been successfully completed and released, and a GLP toxicity study has concluded. We are also in the planning stages for a phase I clinical trial and assessing a vaccine candidate for potential use in a clinical trial with sheep.
Furthermore, we explored immune responses in various categories of CCHF patients using our developed assays and biobank. Additionally, progress has been made in delineating an immune signature indicative of protective immunity by aggregating data related to pro-inflammatory and omics responses observed in patients with Crimean-Congo Hemorrhagic Fever (CCHF).
Moreover, GMP manufacturing has been successfully completed and released, and a GLP toxicity study has concluded. We are also in the planning stages for a phase I clinical trial and assessing a vaccine candidate for potential use in a clinical trial with sheep.
The project has yielded to a novel candidate, now poised for Phase I clinical testing. If approved by the EMA, this could mark the initiation of the first clinical trial for a CCHF vaccine. Additionally, the CCHFV patient sample Biobank has played a crucial role in generating datasets on adaptive immune and omic responses to CCHFV, offering insights that could significantly contribute to the development of life-saving vaccines and therapeutics. Several compelling research reports are in the pipeline for publication.
Moreover, our collaborative efforts have facilitated the establishment of fruitful relationships with CCHF-endemic countries, including not only Turkey and Tajikistan but also South Africa and India. Interactions with leading Biotech companies, such as Pfizer, Astra, and Biontech, have been initiated, positioning us as a valuable resource in the ongoing fight against CCHF. In exciting developments, we are currently exploring potential clinical trials in collaboration with the Indian Council for Medical Research and the International Vaccine Institute. In summary, the project's success may impact European policies in public health, research funding, international collaboration, regulatory frameworks and industry partnerships, addressing current and future health challenges.
Moreover, our collaborative efforts have facilitated the establishment of fruitful relationships with CCHF-endemic countries, including not only Turkey and Tajikistan but also South Africa and India. Interactions with leading Biotech companies, such as Pfizer, Astra, and Biontech, have been initiated, positioning us as a valuable resource in the ongoing fight against CCHF. In exciting developments, we are currently exploring potential clinical trials in collaboration with the Indian Council for Medical Research and the International Vaccine Institute. In summary, the project's success may impact European policies in public health, research funding, international collaboration, regulatory frameworks and industry partnerships, addressing current and future health challenges.