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Efficacy and safety of vi-tetanus toxoid conjugated typhoid vaccine (PedaTyph™) in Indian children: School based cluster randomized study.
Hum Vaccin Immunother. 2016 04 02; 12(4):939-45.HV

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 (95% CI: 27.0 EU/ml, 39.0 EU/ml) and 14 EU/ml (95% CI: 12.0 EU/ml, 17.0 EU/ml) at baseline, 6 weeks and 12 months, respectively was observed. Sero-conversion among the sub-group was 100% after 6 weeks of post-vaccination and 83% after 12 months considering 4-fold rise from baseline. The efficacy of vaccine was 100 % (95% CI: 97.6%, 100%) in the first year of follow-up with minimal AEs post vaccination. Vi conjugate typhoid vaccine conferred 100% protection against typhoid fever in 1765 children 6 months to 12 years of age with high immunogenicity in a subgroup from the vaccine arm.

Authors+Show Affiliations

a Institute of Child Health , Kolkata , India.b Department of Pediatrics , Lion's Tarachand Bapa Hospital, Sion West , Mumbai , India.a Institute of Child Health , Kolkata , India.c Department of Pharmacology , Institute of Postgraduate Medical Education and Research , Kolkata , India.d Department of Microbiology , U.C.M.S, GTB Hospital , Delhi , India.a Institute of Child Health , Kolkata , India.a Institute of Child Health , Kolkata , India.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

26901576

Citation

Mitra, Monjori, et al. "Efficacy and Safety of Vi-tetanus Toxoid Conjugated Typhoid Vaccine (PedaTyph™) in Indian Children: School Based Cluster Randomized Study." Human Vaccines & Immunotherapeutics, vol. 12, no. 4, 2016, pp. 939-45.
Mitra M, Shah N, Ghosh A, et al. Efficacy and safety of vi-tetanus toxoid conjugated typhoid vaccine (PedaTyph™) in Indian children: School based cluster randomized study. Hum Vaccin Immunother. 2016;12(4):939-45.
Mitra, M., Shah, N., Ghosh, A., Chatterjee, S., Kaur, I., Bhattacharya, N., & Basu, S. (2016). Efficacy and safety of vi-tetanus toxoid conjugated typhoid vaccine (PedaTyph™) in Indian children: School based cluster randomized study. Human Vaccines & Immunotherapeutics, 12(4), 939-45. https://doi.org/10.1080/21645515.2015.1117715
Mitra M, et al. Efficacy and Safety of Vi-tetanus Toxoid Conjugated Typhoid Vaccine (PedaTyph™) in Indian Children: School Based Cluster Randomized Study. Hum Vaccin Immunother. 2016 04 2;12(4):939-45. PubMed PMID: 26901576.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of vi-tetanus toxoid conjugated typhoid vaccine (PedaTyph™) in Indian children: School based cluster randomized study. AU - Mitra,Monjori, AU - Shah,Nitin, AU - Ghosh,Apurba, AU - Chatterjee,Suparna, AU - Kaur,Iqbal, AU - Bhattacharya,Nisha, AU - Basu,Suparna, Y1 - 2016/02/22/ PY - 2016/2/23/entrez PY - 2016/2/24/pubmed PY - 2017/10/27/medline KW - PedaTyph™ KW - Typhoid KW - conjugate vaccine KW - efficacy KW - geometric mean titer (GMT) KW - immunogenicity SP - 939 EP - 45 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 12 IS - 4 N2 - 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 (95% CI: 27.0 EU/ml, 39.0 EU/ml) and 14 EU/ml (95% CI: 12.0 EU/ml, 17.0 EU/ml) at baseline, 6 weeks and 12 months, respectively was observed. Sero-conversion among the sub-group was 100% after 6 weeks of post-vaccination and 83% after 12 months considering 4-fold rise from baseline. The efficacy of vaccine was 100 % (95% CI: 97.6%, 100%) in the first year of follow-up with minimal AEs post vaccination. Vi conjugate typhoid vaccine conferred 100% protection against typhoid fever in 1765 children 6 months to 12 years of age with high immunogenicity in a subgroup from the vaccine arm. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/26901576/Efficacy_and_safety_of_vi_tetanus_toxoid_conjugated_typhoid_vaccine__PedaTyph™__in_Indian_children:_School_based_cluster_randomized_study_ DB - PRIME DP - Unbound Medicine ER -