Safety and Immunogenicity of a Vi Polysaccharide–Tetanus Toxoid Conjugate Vaccine (Typbar-TCV) in Healthy Infants, Children, and Adults in Typhoid Endemic Areas: A Multicenter, 2-Cohort, Open-Label, Double-Blind, Randomized Controlled Phase 3 Study

Abstract

CTRI/2011/08/001957, CTRI/2014/01/004341.

Cost-effectiveness analysis of typhoid conjugate vaccines in five endemic low- and middle-income settings

“…We used efficacy data from a clinical trial of the two-dose Vi-rEPA conjugate vaccine to inform the probability of vaccine protection and duration of immunity (see S1 Appendix §4) [10]. The leading TCV candidate (Typbar-TCV, Bharat Biotech) was proven effective on the basis of serological surrogates of efficacy, suggesting that a single dose would provide comparable protection to Vi-rEPA [13], [14], [15]. All of the data we used to parameterize the costs of treatment and vaccination came from micro-costing studies, except for vaccine administrative costs in India, which came from the country Multi-Year Plan (see S1 Appendix §6) [31], [32], [33].…”

“…Newly-developed typhoid conjugate vaccines (TCVs) may prompt greater programmatic use [8], [9]. Whereas existing vaccines confer 50–70% protection for 3–5 years in individuals over 2 years of age, TCVs have a higher efficacy, longer duration of protection, and are safe and immunogenic in children as young as 6 months old, making TCVs compatible with existing infant immunization programs [10], [11], [12], [13], [14]. In light of the recent licensure of TCVs in India and the anticipated licensure in other countries, the WHO will soon be updating their recommendations for typhoid vaccine use [15], [16].…”

An Appraisal of the Clinical Features of Pediatric Enteric Fever: Systematic Review and Meta-analysis of the Age-Stratified Disease Occurrence

“…The proportion of cases clinical suspected with enteric fever may be as low as 4% at initial presentation in ultimately blood culture–confirmed cases in children [38]. Clinical features, complications, and outcomes differ between adults and children; even among children, differences exist between infants and older children as well as between children in Africa and Asia [3].…”

Typhoid conjugate vaccines: making vaccine history in Africa

“…Immunogenicity data from a phase 3 study of the Tybar-TCV performed in India demonstrated consistently higher anti-Vi IgG responses than the Vi-polysaccharide control (anti-Vi IgG 1292 to 1937 EU/ml Typbar-TCV ® vs. 411 EU/ml Typbar Vi). The vaccine was noted to be immunogenic in children under 2 years of age, and long-term persistence of anti-Vi has been demonstrated from 3 to 5 years postvaccination [19].…”