EuTYPH-C Inj.® Multi-dose is a TCV manufactured by EuBiologics Co., LTD, and is one of several additional TCVs in development that could help to diversify the TCV market. Previous studies conducted in the Philippines found EuTYPH-C to be safe and to generate a strong immune response.
PATH led a Phase 3 study, in partnership with EuBiologics and the study sites in Kenya and Senegal, to assess the safety and non-inferiority of EuTYPH-C Inj. Multi-dose compared to a World Health Organization (WHO)-prequalified product, Typbar TCV, in adults, children, and infants. Results, recently published in The Lancet Global Health, showed that EuTYPH-C Inj. Multi-dose was safe and immunogenic in typhoid-endemic populations in sub-Saharan Africa.
Safety was comparable across all groups, with no serious adverse events related to vaccination reported. Immune responses demonstrated that EuTYPH-C Inj. Multi-dose was non-inferior to Typbar TCV. At 28-days post-vaccination, seroconversion rates (a measure of the body’s immune response) were 100% for the single-dose presentation of EuTYPH-C Inj. Multi-dose, 99.6% for the multi-dose presentation of EuTYPH-C Inj. Multi-dose, and 98% for Typbar TCV groups. Seroconversion rates remained high at 6 months post-vaccination.
“The strong safety profile and immunogenicity results for EuTYPH-C Inj. Multi-dose demonstrate the promise of this vaccine in preventing typhoid in endemic countries,” says Patricia Njuguna, Senior Medical Officer and project lead of the study from PATH.
The study also assessed co-administration of EuTYPH-C Inj. Multi-dose with measles-rubella and yellow fever vaccines at 9-12 months of age. Results showed that co-administration did not interfere with immune responses to the different pathogens.
These results are the pivotal data to support WHO prequalification. WHO prequalification is a designation that ensures a vaccine meets strict international quality, safety, and efficacy standards and that allows it to be procured by United Nations agencies and Gavi.