Abstract
Safety and immunogenicity of the Vi-DT typhoid conjugate vaccine in healthy volunteers in Nepal: an observer-blind, active-controlled, randomised, non-inferiority, phase 3 trial
Highlights
Typhoid fever, caused by Salmonella enterica serovar Typhi (S Typhi), is an important cause of morbidity and mortality in low-income and middle-income countries.[1,2] Typhoid fever is more common in children and young adults than in older people, and is most prevalent in impoverished and overcrowded areas with poor sanitation.[2,3,4] typhoid fever can be effectively treated with antibiotics, the growing rates of antibiotic resistance in many countries are making available treatment options increasingly less effective and costly.[5]
Patients with an acute or chronic illness that could interfere with interpretation of the study endpoints, or who were involved in any other clinical trial were excluded
Our results show that the Vi polysaccharide-diphtheria toxoid (Vi-DT) vaccine is non-inferior to the Typbar typhoid conjugate vaccine (TCV) vaccine and has a similar safety profile
Summary
Typhoid fever, caused by Salmonella enterica serovar Typhi (S Typhi), is an important cause of morbidity and mortality in low-income and middle-income countries.[1,2] Typhoid fever is more common in children and young adults than in older people, and is most prevalent in impoverished and overcrowded areas with poor sanitation.[2,3,4] typhoid fever can be effectively treated with antibiotics, the growing rates of antibiotic resistance in many countries are making available treatment options increasingly less effective and costly.[5] Early intervention with vaccination, especially in children younger than 2 years, is essential.[6,7] The 2018 WHO position paper recommends that countries should consider the use of typhoid vaccines for high-risk groups and populations, and for outbreak control.[8] In endemic countries, control of typhoid fever would require implementing immunisation of young children (ie, those aged up to 15 years) and incorporating the typhoid vaccine in the Expanded Program on Immunization schedule.[7,9]
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