In a landmark advancement for global public health, the Phase 3 clinical trial results of EuTYPH-C Inj.® Multi-dose, a typhoid conjugate vaccine (TCV) developed by EuBiologics Co., Ltd. in the Republic of Korea, have been unveiled, illustrating impressive safety and robust immunogenicity in populations from typhoid-endemic regions of sub-Saharan Africa. These findings, now published in the esteemed journal The Lancet Global Health, represent a crucial step forward in combating typhoid fever, particularly among vulnerable demographics in Kenya and Senegal where the burden of this disease is acute.
Typhoid fever remains a formidable challenge to health systems in endemic areas, primarily affecting children under 15 but also posing risks across age groups. The causative agent, Salmonella Typhi, thrives in regions with inadequate sanitation infrastructure, and the emerging threat of antimicrobial resistance exacerbates the urgent need for efficacious vaccines. Against this backdrop, EuTYPH-C Inj.® Multi-dose offers renewed hope by meeting stringent international benchmarks for safety and immunogenicity, thereby promising enhanced protection and facilitating broader vaccine coverage.
This multicenter Phase 3 trial employed a randomized, observer-blind methodology encompassing over 3,200 healthy participants aged from six months to 45 years at two African sites—Kericho in Kenya and Sandiara in Senegal. Participants were administered either EuTYPH-C Inj.® Multi-dose or the World Health Organization (WHO)-prequalified Typbar TCV®. Comprehensive safety assessments revealed a tolerability profile for EuTYPH-C that was consistent with, if not superior to, the comparator vaccine, with no vaccine-related serious adverse events observed throughout the study duration.
Critically, immunogenicity evaluations centered on infants aged 9 to 12 months demonstrated that immune responses elicited by both single-dose and multi-dose formats of EuTYPH-C were not inferior to Typbar TCV®. High seroconversion rates were documented 28 days post-vaccination and sustained at six months, indicating durable antibody-mediated protection. Furthermore, EuTYPH-C displayed compatibility with the co-administration of measles-rubella and yellow fever vaccines—a significant finding that supports integrated immunization schedules without compromising immunologic efficacy.
Dr. Patricia Njuguna, the senior medical officer and project lead from PATH, emphasized the paramount importance of safety in vaccine deployment, underscoring that EuTYPH-C’s safety profile reassures its suitability for mass immunization campaigns across diverse age groups. The absence of serious adverse events related to the vaccine is notable, especially in pediatric cohorts where tolerability often dictates programmatic success.
The successful licensure of EuTYPH-C Inj.® Multi-dose by the Korean Ministry of Food and Drug Safety, bolstered by Phase 3 data, positions the vaccine for imminent submission to the WHO for prequalification. This designation is essential for procurement by UN agencies and Gavi, the Vaccine Alliance, which play critical roles in vaccine distribution to low- and middle-income countries. Increasing the portfolio of WHO-prequalified TCVs actively contributes to fostering competitive pricing, ensuring supply resiliency, and accelerating access to lifesaving immunizations.
EuBiologics, the manufacturer based in Seoul, has a commendable track record, including WHO prequalification of their oral cholera vaccine, highlighting their expertise in vaccine development and global health contributions. The introduction of EuTYPH-C into the typhoid vaccine market is anticipated to further diversify and stabilize supply chains, a vital consideration given the escalating demand in Gavi-supported countries where seven have already integrated TCVs into national immunization programs.
Typhoid remains a major public health threat, with more than 7 million cases and over 93,000 deaths estimated globally in 2021, predominantly in Asia and sub-Saharan Africa. Given the rise in drug-resistant strains of Salmonella Typhi, vaccination emerges as an indispensable preventive tool alongside improvements in water, sanitation, and hygiene infrastructure. Over 90 million doses of TCVs have already been administered globally, yet vaccine access and affordability continue to be barriers in many high-burden regions.
The robust immune responses observed with EuTYPH-C, its safety, and ability to be co-administered with other childhood vaccines underscore its potential for seamless integration into existing immunization schedules. Such integration is critical to optimizing healthcare delivery efficiencies and increasing vaccination coverage among vulnerable populations, particularly infants and young children who bear the highest disease burden.
This trial represents a successful collaboration among international stakeholders, including PATH, EuBiologics, Kenya Medical Research Institute (KEMRI), Walter Reed Army Institute of Research (WRAIR), and the Institut de Recherche en Santé, de Surveillance Epidémiologique et de Formation (IRESSEF). Funding support from EuBiologics and the RIGHT Foundation underscores the importance of public-private partnerships in driving vaccine innovation and equitable health advancements globally.
Looking ahead, WHO prequalification of EuTYPH-C will enhance the vaccine’s availability for widespread use, potentially transforming typhoid prevention strategies in endemic countries. Expanding the vaccine arsenal is pivotal to combating the persistent challenges posed by typhoid fever, ultimately reducing morbidity and mortality, and contributing to the global agenda for vaccine-preventable disease control and elimination.
EuTYPH-C Inj.® Multi-dose exemplifies cutting-edge conjugate vaccine technology that leverages the Vi polysaccharide antigen coupled with CRM197 carrier protein to evoke a strong, persistent immune response. This immunological strategy addresses the limitations of earlier polysaccharide vaccines, which were less efficacious particularly in young children, by inducing T-cell-dependent immunity and immune memory—an essential feature for durable protection and herd immunity.
The trial’s rigorous design, encompassing lot-to-lot consistency and evaluation across various age cohorts, provides comprehensive data supporting the vaccine’s quality and effectiveness. Such robust scientific evidence is instrumental in informing policy makers, immunization programs, and global health stakeholders in their decisions to scale TCV deployment and optimize typhoid control efforts.
In summary, the publication of EuTYPH-C Inj.® Multi-dose Phase 3 clinical trial data marks a significant milestone in typhoid vaccine research and public health practice. This vaccine’s demonstrated safety, immunogenicity, and operational compatibility position it as a key addition to the international fight against typhoid fever, particularly within sub-Saharan Africa and other regions grappling with endemic disease and the rising threat of antimicrobial resistance.
Subject of Research: People
Article Title: A Multi-Center, Observer-Blind, Randomized, Phase 3 Study to Evaluate Safety, Non-Inferiority of Multi-Dose and Single-Dose Vial Formulations of EuTCV (Vi-CRM197 Typhoid Conjugate Vaccine) and Lot-to-Lot Consistency of the Immune Response to Multi-Dose Vial Formulation EuTCV in Healthy Participants in Kenya and Senegal
News Publication Date: 12-Nov-2025
Image Credits: Photo courtesy of EuBiologics Co., Ltd.
Keywords: Vaccine development, Vaccine research, Clinical research, Typhoid, Bacterial infections, Vaccination, Africa, Asia, Infectious diseases, Public health, Clinical trials, Preventive medicine
