• IVI and KDCA/KNIH partner to collect and test plasma from SFTS patients, collaborating with MHRA to produce international standard materials of high-titer plasma

May 15, 2025, SEOUL, Republic of Korea — The International Vaccine Institute (IVI) has been awarded a grant from the Coalition for Epidemic Preparedness Innovations (CEPI) to support the development of international standard reference materials for vaccine trials against Severe Fever with Thrombocytopenia Syndrome (SFTS), a deadly tick-borne viral disease caused by Dabie bandavirus (DBV) for which no human vaccine currently exists.

In collaboration with the Korea National Institute of Health (KNIH) under the Korea Disease Control and Prevention Agency (KDCA), plasma from individuals who have recovered from SFTS will be collected, and antibody titers will be analyzed to identify high-quality donor material.

This effort marks a critical step toward establishing a World Health Organization (WHO) international standard for anti-Dabie bandavirus (DBV) antibodies—an essential tool for evaluating vaccine-induced immune responses in clinical trials.

Serum samples demonstrating high neutralizing antibody titers will be transferred to the National Institute for Biological Standards and Control (NIBSC), part of the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), for the development of WHO candidate standard materials. The collaboration aims to secure sufficient quantities of high-titer plasma to support large-scale vaccine testing and enable validation of immunological assays across platforms.

During the pandemic, IVI supported the establishment of the WHO International Standard for the evaluation of antibody titers to the COVID-19 virus. In addition, IVI successfully conducted clinical trial sample analysis for Korea’s first COVID-19 vaccine in collaboration with KNIH.

SFTS is an emerging zoonotic disease, with a case fatality rate of 18.4 percent in Korea. Transmitted by the Haemaphysalis longicornis tick—whose global spread is being accelerated by climate change—the disease poses an increasing threat of emergence beyond East Asia. While several vaccine candidates have shown promise in preclinical studies, progress has been limited by the lack of standardized tools to consistently assess DBV-specific immune responses.

Since 2022, IVI has led the preclinical development of a bivalent vaccine targeting both SFTS and Hemorrhagic Fever with Renal Syndrome (HFRS). Recent milestones include:

• Development and qualification of preclinical efficacy and neutralization assays
• Establishment of a standardized mouse challenge model for SFTS
• Optimization of infection routes and analytical methods for platelet counts and viral RNA detection in tissues

These advancements are expected to accelerate the evaluation and selection of a lead bivalent vaccine candidate, facilitating its transition to clinical development.

Dr. Manki Song, Deputy Director General of Science at IVI, said “Through these efforts and the new CEPI-funded project, IVI aims to contribute to the broader mission of building a vaccine library for rapid response to emerging infectious diseases with pandemic potential.”

CEPI is supporting STFS vaccine development efforts as a potential disease target to help accelerate development of vaccine candidates against other pathogens in the same viral family, including a future novel or as-yet-identified ‘Disease X’ that could cause a serious epidemic or pandemic.

(For more information, refer to https://cepi.net/how-disease-survivors-antibodies-shape-lifesaving-vaccines)

Dr. Jerome Kim, Director General of IVI, said, “SFTS poses constant threat in public health in East Asia including Korea. IVI is committed to supporting the development of vaccines against emerging and reemerging infectious diseases including SFTS, as part of concerted global efforts to prepare for future pandemics. We are grateful to CEPI and KNIH for their support and robust collaboration.”

Dr. Hyun-young Park, Director of KNIH, said, “This international collaborative research project, which involves collaborating with global partners in the entire process from securing biological resources to certifying standard substances, will be a foundation for responding to emerging infectious diseases.”

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About the International Vaccine Institute (IVI)
The International Vaccine Institute (IVI) is a non-profit international organization established in 1997 at the initiative of the United Nations Development Programme with a mission to discover, develop, and deliver safe, effective, and affordable vaccines for global health.

IVI’s current portfolio includes vaccines at all stages of pre-clinical and clinical development for infectious diseases that disproportionately affect low- and middle-income countries, such as cholera, typhoid, chikungunya, shigella, salmonella, schistosomiasis, hepatitis E, HPV, COVID-19, and more. IVI developed the world’s first low-cost oral cholera vaccine, pre-qualified by the World Health Organization (WHO), and developed a new-generation typhoid conjugate vaccine that also achieved WHO prequalification in early 2024.

IVI is headquartered in Seoul, Republic of Korea with a Europe Regional Office in Sweden, an Africa Regional Office in Rwanda, a Country Office in Austria, and a Country and Project Office in Kenya. IVI additionally co-founded the Hong Kong Jockey Club Global Health Institute in Hong Kong and hosts Collaborating Centers in Ghana, Ethiopia, and Madagascar. 42 countries and the WHO are members of IVI, and the governments of the Republic of Korea, Sweden, India, Finland, Austria, and Thailand provide state funding. For more information, please visit https://www.ivi.int.