EuTYPH-C Inj. Multi-dose is manufactured by EuBiologics Co., Ltd., Republic of Korea. Credit score: EuBiologics Co.
Part III outcomes from a scientific trial of a typhoid conjugate vaccine (TCV), EuTYPH-C Inj. Multi-dose, show that it’s protected and immunogenic in typhoid-endemic populations in sub-Saharan Africa. EuTYPH-C Inj. Multi-dose is manufactured by EuBiologics Co., LTD, Republic of Korea.
The examine, revealed in The Lancet International Well being, was performed at websites in Kenya and Senegal in wholesome adults, youngsters, and infants, and evaluated the security and noninferiority of EuTYPH-C Inj. Multi-dose in comparison with a World Well being Group (WHO) prequalified comparator TCV, Typbar TCV.
The examine additionally assessed coadministration of EuTYPH-C Inj. Multi-dose with measles-rubella and yellow fever vaccines at 9–12 months of age and antibody ranges over six months.
Security and immune response findings
“Safety is of paramount importance when evaluating a new vaccine. EuTYPH-C Inj. Multi-dose was shown to be well tolerated across all age groups, with a similar safety profile to the comparator vaccine,” says Patricia Njuguna, Senior Medical Officer, and venture lead of the examine from PATH. “No safety concerns were identified, with no serious adverse events related to vaccination noted.”
Immunogenicity, which measures the physique’s immune response, was evaluated in individuals 9 to 12 months of age. Immune responses from each single-dose and multi-dose displays of EuTYPH-C Inj. Multi-dose had been noninferior to Typbar TCV at 28 days post-vaccination.
Seroconversion charges had been excessive at 28 days post-vaccination and remained excessive at six months post-vaccination. Moreover, coadministration of EuTYPH-C Inj. Multi-dose with different childhood vaccines didn’t intervene with immune responses to the totally different pathogens.
Implications for vaccine entry and provide
“These results are a positive step toward our goal of providing a safe and effective vaccine to prevent typhoid in endemic areas. They are the pivotal data that supported licensure from the Korean Ministry of Food and Drug Safety and will support WHO prequalification, which is our next step for this vaccine,” says Youngjin Choi, Managing Director, Medical Improvement Division, EuBiologics Co., LTD.
“We welcome the results from this trial and are looking forward to supplying EuTYPH-C Inj. Multi-dose to countries with a high burden of typhoid.”
WHO prequalification is a designation that ensures a vaccine meets strict worldwide high quality, security, and efficacy requirements and that permits it to be procured by United Nations businesses and Gavi, the Vaccine Alliance.
There are presently 4 prequalified TCV merchandise, two of which can be found for Gavi-eligible international locations. Extra merchandise from various producers assist to drive down vaccine costs, keep a robust wholesome provide, and enhance entry.
International demand and future outlook
“Demand for TCVs in Gavi-eligible typhoid endemic countries has been high. To date, seven Gavi-eligible countries have introduced TCV, with several more in various stages of the planning and introduction process,” says Dr. Emmanuel Mugisha, International Director for Vaccine Implementation and Director of TyVAC at PATH, a consortium that goals to speed up the introduction of TCVs in typhoid-endemic international locations.
“The potential for an additional product will help ensure a stable vaccine supply for countries interested in introducing TCV as part of their typhoid prevention and control plans.”
This examine enrolled 3,219 wholesome individuals aged 6 months to 45 years outdated at two examine websites in Kericho, Kenya, and Sandiara, Senegal.
Research companions included PATH, EuBiologics Co., LTD, Kenya Medical Analysis Institute (KEMRI)-Walter Reed Military Institute of Analysis (WRAIR) Kericho, and Institut de Recherche en Santé, de Surveillance Epidémiologique et de Formation (IRESSEF).
Extra data:
Birahim Pierre Ndiaye, et al. A Multi-Middle, Observer-Blind, Randomized, Part 3 Research to Consider Security, 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 Wholesome Members in Kenya and Senegal, The Lancet International Well being (2025). DOI: 10.1016/S2214-109X(25)00330-4
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Typhoid conjugate vaccine demonstrates robust security and immunogenicity in Part III trial (2025, November 13)
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