Nginache Nampota-Nkomba, Osward M Nyirenda, Shrimati Datta, Victoria Mapemba, Priyanka D Patel, Theresa Misiri, Felistas Mwakiseghile, John M Ndaferankhande, Bright Lipenga, Jennifer Oshinsky, Marcela F Pasetti, Leslie P Jamka, Melita A Gordon, Matthew B Laurens, Kathleen M Neuzil
{"title":"Immunogenicity and reactogenicity of a booster dose of a typhoid conjugate vaccine (TCV) in Malawian pre-school children.","authors":"Nginache Nampota-Nkomba, Osward M Nyirenda, Shrimati Datta, Victoria Mapemba, Priyanka D Patel, Theresa Misiri, Felistas Mwakiseghile, John M Ndaferankhande, Bright Lipenga, Jennifer Oshinsky, Marcela F Pasetti, Leslie P Jamka, Melita A Gordon, Matthew B Laurens, Kathleen M Neuzil","doi":"10.1016/j.eclinm.2025.103100","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>We assessed persistence of typhoid immunity conferred by Vi polysaccharide-tetanus toxoid (Vi-TT) conjugate vaccine (TCV) four years post-vaccination and immunogenicity of a booster dose of Vi-TT given at age five.</p><p><strong>Methods: </strong>In 2018, a phase 3 trial of Vi-TT in Malawi randomised children 1:1 to receive Vi-TT or meningococcal capsular group A conjugate vaccine (control). Subsequently, TCV was licensed and recommended in the region. In 2023, children vaccinated at 9-11 months in the original trial received a second (Booster- TCV) or first (1st-TCV) Vi-TT dose, at age five. Serum collected at days 0, 28, and 160-180 days after vaccination was tested for anti-Vi immunoglobulin (Ig)G and IgA, reported as enzyme-linked immunosorbent assay units (EU)/mL. Seroconversion was ≥4-fold rise in antibody titers from day 0 to day 28 post-vaccination. Safety outcomes included adverse events during follow-up.</p><p><strong>Findings: </strong>We enrolled 136 children: 72 Booster-TCV and 64 1st-TCV. At baseline, anti-Vi IgG geometric mean titers (GMT) were higher in Booster-TCV (18.8 EU/mL, 95% CI 15.2-23.2) than 1st-TCV (5.7 EU/mL, 4.6-7.2) arms. GMT increased significantly between days 0 and 28 in both arms, with higher levels in Booster-TCV (6867.9 EU/mL, 5794.1-8140.6) than 1st-TCV (2912.0 EU/mL, 2429.2-3490.7) arms, representing a 375.7 and 492.6 geometric mean fold rise, respectively. On day 28, all Booster-TCV children, and all but one 1st-TCV child, seroconverted. Similar trends were seen for IgA. Vi-TT reactogenicity was similar between vaccine arms.</p><p><strong>Interpretation: </strong>This study demonstrates sustained Vi-TT immunogenicity four years post-vaccination at 9-11 months old, and robust immune response following a booster dose at five years of age, informing policy decisions on TCV use in children.</p><p><strong>Funding: </strong>Bill & Melinda Gates Foundation (INV-030857).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103100"},"PeriodicalIF":10.0000,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11872497/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"EClinicalMedicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.eclinm.2025.103100","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/3/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background: We assessed persistence of typhoid immunity conferred by Vi polysaccharide-tetanus toxoid (Vi-TT) conjugate vaccine (TCV) four years post-vaccination and immunogenicity of a booster dose of Vi-TT given at age five.
Methods: In 2018, a phase 3 trial of Vi-TT in Malawi randomised children 1:1 to receive Vi-TT or meningococcal capsular group A conjugate vaccine (control). Subsequently, TCV was licensed and recommended in the region. In 2023, children vaccinated at 9-11 months in the original trial received a second (Booster- TCV) or first (1st-TCV) Vi-TT dose, at age five. Serum collected at days 0, 28, and 160-180 days after vaccination was tested for anti-Vi immunoglobulin (Ig)G and IgA, reported as enzyme-linked immunosorbent assay units (EU)/mL. Seroconversion was ≥4-fold rise in antibody titers from day 0 to day 28 post-vaccination. Safety outcomes included adverse events during follow-up.
Findings: We enrolled 136 children: 72 Booster-TCV and 64 1st-TCV. At baseline, anti-Vi IgG geometric mean titers (GMT) were higher in Booster-TCV (18.8 EU/mL, 95% CI 15.2-23.2) than 1st-TCV (5.7 EU/mL, 4.6-7.2) arms. GMT increased significantly between days 0 and 28 in both arms, with higher levels in Booster-TCV (6867.9 EU/mL, 5794.1-8140.6) than 1st-TCV (2912.0 EU/mL, 2429.2-3490.7) arms, representing a 375.7 and 492.6 geometric mean fold rise, respectively. On day 28, all Booster-TCV children, and all but one 1st-TCV child, seroconverted. Similar trends were seen for IgA. Vi-TT reactogenicity was similar between vaccine arms.
Interpretation: This study demonstrates sustained Vi-TT immunogenicity four years post-vaccination at 9-11 months old, and robust immune response following a booster dose at five years of age, informing policy decisions on TCV use in children.
Funding: Bill & Melinda Gates Foundation (INV-030857).
期刊介绍：
eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
