Periodic Reporting for period 5 - CCHFVaccine (Crimean-Congo Haemorrhagic Fever Vaccine)
Reporting period: 2023-01-01 to 2023-12-31
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.
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.
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.