A groundbreaking typhoid conjugate vaccine, EuTYPH-C Inj.®, has demonstrated remarkable safety and immune response in Africa, paving the way for a new era of typhoid prevention. The vaccine, developed by EuBiologics Co., LTD, Republic of Korea, in collaboration with PATH, has shown promising results in a Phase 3 clinical trial published in The Lancet Global Health.
The study, conducted in Kenya and Senegal, involved healthy adults, children, and infants, and compared the safety and effectiveness of EuTYPH-C Inj.® Multi-dose to a prequalified typhoid conjugate vaccine, Typbar TCV®. The trial's findings are particularly significant for typhoid-endemic regions in sub-Saharan Africa, where the disease poses a severe threat to children under 15 years old.
One of the key strengths of the vaccine is its safety profile. Patricia Njuguna, a Senior Medical Officer and project lead, emphasizes, "Safety is paramount. EuTYPH-C Inj.® Multi-dose was well-tolerated across all age groups, with no serious adverse events reported."
In terms of immunogenicity, the vaccine's ability to elicit an immune response was evaluated in participants aged 9 to 12 months. The results revealed that both single-dose and multi-dose administrations of EuTYPH-C Inj.® Multi-dose were non-inferior to Typbar TCV® at 28 days post-vaccination. Seroconversion rates were exceptionally high, remaining strong at 6 months post-vaccination. Moreover, the vaccine's co-administration with other childhood vaccines, such as measles-rubella and yellow fever, did not compromise its immune responses.
Youngjin Choi, Managing Director of EuBiologics Co., LTD, highlights the significance of these findings: "These results are a significant step towards our goal of providing a safe and effective typhoid vaccine in endemic areas. They are pivotal data that supported the Korean Ministry of Food and Drug Safety's licensure and will facilitate WHO prequalification, our next crucial step."
WHO prequalification is a critical process that ensures vaccines meet stringent international standards for quality, safety, and efficacy. This designation enables United Nations agencies and Gavi, the Vaccine Alliance, to procure the vaccines. Currently, four prequalified typhoid conjugate vaccines are available, with two accessible to Gavi-eligible countries. The introduction of additional products from diverse manufacturers helps drive down vaccine prices, maintain a robust supply chain, and enhance access.
The demand for typhoid conjugate vaccines in Gavi-eligible endemic countries is high. Seven countries have already introduced these vaccines, and several more are in the planning and implementation stages. Dr. Emmanuel Mugisha, Global Director for Vaccine Implementation and Director of TyVAC at PATH, notes, "The availability of an additional product will ensure a stable vaccine supply for countries interested in typhoid prevention and control."
The clinical trial involved 3,219 healthy participants aged 6 months to 45 years old, enrolled at two study sites in Kericho, Kenya, and Sandiara, Senegal. The study was a collaborative effort involving PATH, EuBiologics Co., LTD, Kenya Medical Research Institute (KEMRI)-Walter Reed Army Institute of Research (WRAIR) Kericho, and Institut de Recherche en Santé, de Surveillance Epidémiologique et de Formation (IRESSEF). The study was funded by EuBiologics Co., LTD and the RIGHT Foundation, grant number RF-2021-V01.
Typhoid, a severe and potentially life-threatening illness, predominantly affects children under 15 years old in Asia and sub-Saharan Africa. The Global Burden of Disease study estimates a staggering 7 million cases and over 93,000 deaths due to typhoid in 2021. While typhoid is treatable with antibiotics, the rise of drug-resistant strains underscores the urgency of preventive measures, including the introduction of typhoid conjugate vaccines and improvements in water, sanitation, and hygiene. To date, over 90 million children have been vaccinated with typhoid conjugate vaccines through various introduction campaigns.
This groundbreaking research paves the way for a safer and more effective approach to typhoid prevention, offering hope for the millions affected by this debilitating disease.
