Efficacy and safety of vi-tetanus toxoid conjugated typhoid vaccine (PedaTyph™) in Indian children: School based cluster randomized study

Human Vaccines & Immunotherapeutics
Monjori MitraSuparna Basu

Abstract

Vi polysaccharide typhoid vaccines cannot be used in children <2 years owing to poor immunogenic and T cell independent properties. Conjugate vaccine prepared by binding Vi to tetanus toxoids (Vi-TT) induces protective levels even in children <2 years. We evaluated efficacy and safety following vaccination with a Vi-TT vaccine in children 6 months to 12 years of age. Overall, 1765 subjects were recruited from two registered municipal urban slums of southern Kolkata. Most of the children of the slum dwellers attended the schools in the locality which was selected with permission from the school authority. Schools were randomly divided into vaccinated (Test group) and unvaccinated group (Control group). Children and their siblings of test group received 2-doses of PedaTyph™ vaccine at 6 weeks interval. Control group received vaccines as per national guidelines. Adverse events (AEs) were examined after 30 minutes, 1 month and clinical events were observed till 12 months post-vaccination. Incidence of culture positive typhoid fever in the control group was 1.27% vis-a-vis none in vaccine group during 12 months. In subgroup evaluated for immunogenicity, an antibody titer value of 1.8 EU/ml (95% CI: 1.5 EU/ml, 2.2 EU/ml), 32 EU/ml (9...Continue Reading

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Citations

Aug 9, 2016·Tropical Medicine & International Health : TM & IH·S DivyashreeP Rupali
Jan 20, 2018·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Merryn Voysey, Andrew J Pollard
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Mar 4, 2020·The American Journal of Tropical Medicine and Hygiene·Phetsavanh ChanthavilayJohn A Crump
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Jul 30, 2020·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Khalid Ali SyedSushant Sahastrabuddhe
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Feb 8, 2021·Journal of Travel Medicine·Abi ManeshPriscilla Rupali
Dec 11, 2020·Travel Medicine and Infectious Disease·Cristina Masuet-Aumatell, Jorge Atouguia

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Methods Mentioned

BETA
IEC
ELISA

Software Mentioned

PedaTyph
graph pad

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