Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of Age

This phase 3B, open-label, extension study (NCT01962207) evaluated long-term persistence of antibodies induced by the quadrivalent meningococcal vaccine conjugated to tetanus toxoid (MenACWY-TT) compared with the meningococcal serogroup C vaccine conjugated to CRM (MenC-CRM) and the quadrivalent men...

Full description

Bibliographic Details
Main Authors: Timo Vesikari, Paula Peyrani, Chris Webber, Marie Van Der Wielen, Brigitte Cheuvart, Nathalie De Schrevel, Emmanuel Aris, Mark Cutler, Ping Li, John L. Perez
Format: Article
Language:English
Published: Taylor & Francis Group 2020-06-01
Series:Human Vaccines & Immunotherapeutics
Subjects:
Online Access:http://dx.doi.org/10.1080/21645515.2020.1746110
_version_ 1797677282754560000
author Timo Vesikari
Paula Peyrani
Chris Webber
Marie Van Der Wielen
Brigitte Cheuvart
Nathalie De Schrevel
Emmanuel Aris
Mark Cutler
Ping Li
John L. Perez
author_facet Timo Vesikari
Paula Peyrani
Chris Webber
Marie Van Der Wielen
Brigitte Cheuvart
Nathalie De Schrevel
Emmanuel Aris
Mark Cutler
Ping Li
John L. Perez
author_sort Timo Vesikari
collection DOAJ
description This phase 3B, open-label, extension study (NCT01962207) evaluated long-term persistence of antibodies induced by the quadrivalent meningococcal vaccine conjugated to tetanus toxoid (MenACWY-TT) compared with the meningococcal serogroup C vaccine conjugated to CRM (MenC-CRM) and the quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS) 6 to 10 y after primary vaccination in toddlers (aged 1–<2 y; MenACWY-TT and MenC-CRM) and children (aged 2–<11 y; MenACWY-TT and MenACWY-PS). Antibody responses against meningococcal serogroups A, C, W, and Y were assessed by serum bactericidal antibody assays using rabbit (rSBA) or human (hSBA) complement. A MenACWY-TT booster dose at Year 10 was given to all eligible subjects regardless of the primary vaccine received. At Year 10, the percentages of subjects with rSBA titers ≥1:8 for serogroups A, C, W, and Y were as follows: MenACWY-TT (toddlers), 65.6%, 82.8%, 31.3%, 43.8%, respectively; MenC-CRM, 88.2% for serogroup C; MenACWY-TT (children), 88.9%, 84.1%, 67.1%, 65.9%; and MenACWY-PS, 28.6%, 81.0%, 23.8%, and 23.8%. Corresponding percentages for hSBA titers ≥1:4 were as follows: MenACWY-TT (toddlers), 31.1%, 91.9%, 44.4%, 41.4%; MenC-CRM, 93.8% for serogroup C; MenACWY-TT (children), 34.8%, 91.1%, 61.2%, 72.6%; and MenACWY-PS, 33.3%, 100.0%, 26.3%, and 44.4%. One month after the MenACWY-TT booster, the percentage of subjects with vaccine response ranged from 75.7% to 100.0% across serogroups in all study groups. Postbooster vaccine responses were generally comparable between groups across serogroups. No new safety signals were identified. Antibody responses persisted 10 y after MenACWY-TT vaccination. The MenACWY-TT booster dose was well tolerated and elicited robust immune responses.
first_indexed 2024-03-11T22:43:02Z
format Article
id doaj.art-6bdfab149b7e46129daca4cb6a55c8a8
institution Directory Open Access Journal
issn 2164-5515
2164-554X
language English
last_indexed 2024-03-11T22:43:02Z
publishDate 2020-06-01
publisher Taylor & Francis Group
record_format Article
series Human Vaccines & Immunotherapeutics
spelling doaj.art-6bdfab149b7e46129daca4cb6a55c8a82023-09-22T08:51:48ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2020-06-011661280129110.1080/21645515.2020.17461101746110Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of AgeTimo Vesikari0Paula Peyrani1Chris Webber2Marie Van Der Wielen3Brigitte Cheuvart4Nathalie De Schrevel5Emmanuel Aris6Mark Cutler7Ping Li8John L. Perez9Nordic Research Network LtdPfizer Vaccine Clinical Research and Development, Pfizer IncPfizer Vaccine Clinical Research and Development, Pfizer LtdGlaxoSmithKlineGlaxoSmithKlineGlaxoSmithKlineGlaxoSmithKlinePfizer Vaccine Research and Development, Pfizer IncPfizer Vaccine Clinical Research and Development, Pfizer IncPfizer Vaccine Clinical Research and Development, Pfizer IncThis phase 3B, open-label, extension study (NCT01962207) evaluated long-term persistence of antibodies induced by the quadrivalent meningococcal vaccine conjugated to tetanus toxoid (MenACWY-TT) compared with the meningococcal serogroup C vaccine conjugated to CRM (MenC-CRM) and the quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS) 6 to 10 y after primary vaccination in toddlers (aged 1–<2 y; MenACWY-TT and MenC-CRM) and children (aged 2–<11 y; MenACWY-TT and MenACWY-PS). Antibody responses against meningococcal serogroups A, C, W, and Y were assessed by serum bactericidal antibody assays using rabbit (rSBA) or human (hSBA) complement. A MenACWY-TT booster dose at Year 10 was given to all eligible subjects regardless of the primary vaccine received. At Year 10, the percentages of subjects with rSBA titers ≥1:8 for serogroups A, C, W, and Y were as follows: MenACWY-TT (toddlers), 65.6%, 82.8%, 31.3%, 43.8%, respectively; MenC-CRM, 88.2% for serogroup C; MenACWY-TT (children), 88.9%, 84.1%, 67.1%, 65.9%; and MenACWY-PS, 28.6%, 81.0%, 23.8%, and 23.8%. Corresponding percentages for hSBA titers ≥1:4 were as follows: MenACWY-TT (toddlers), 31.1%, 91.9%, 44.4%, 41.4%; MenC-CRM, 93.8% for serogroup C; MenACWY-TT (children), 34.8%, 91.1%, 61.2%, 72.6%; and MenACWY-PS, 33.3%, 100.0%, 26.3%, and 44.4%. One month after the MenACWY-TT booster, the percentage of subjects with vaccine response ranged from 75.7% to 100.0% across serogroups in all study groups. Postbooster vaccine responses were generally comparable between groups across serogroups. No new safety signals were identified. Antibody responses persisted 10 y after MenACWY-TT vaccination. The MenACWY-TT booster dose was well tolerated and elicited robust immune responses.http://dx.doi.org/10.1080/21645515.2020.1746110bactericidal activitychildrenconjugate vaccinepersistencequadrivalent meningococcal vaccinetoddlerbooster
spellingShingle Timo Vesikari
Paula Peyrani
Chris Webber
Marie Van Der Wielen
Brigitte Cheuvart
Nathalie De Schrevel
Emmanuel Aris
Mark Cutler
Ping Li
John L. Perez
Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of Age
Human Vaccines & Immunotherapeutics
bactericidal activity
children
conjugate vaccine
persistence
quadrivalent meningococcal vaccine
toddler
booster
title Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of Age
title_full Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of Age
title_fullStr Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of Age
title_full_unstemmed Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of Age
title_short Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of Age
title_sort ten year antibody persistence and booster response to menacwy tt vaccine after primary vaccination at 1 10 years of age
topic bactericidal activity
children
conjugate vaccine
persistence
quadrivalent meningococcal vaccine
toddler
booster
url http://dx.doi.org/10.1080/21645515.2020.1746110
work_keys_str_mv AT timovesikari tenyearantibodypersistenceandboosterresponsetomenacwyttvaccineafterprimaryvaccinationat110yearsofage
AT paulapeyrani tenyearantibodypersistenceandboosterresponsetomenacwyttvaccineafterprimaryvaccinationat110yearsofage
AT chriswebber tenyearantibodypersistenceandboosterresponsetomenacwyttvaccineafterprimaryvaccinationat110yearsofage
AT marievanderwielen tenyearantibodypersistenceandboosterresponsetomenacwyttvaccineafterprimaryvaccinationat110yearsofage
AT brigittecheuvart tenyearantibodypersistenceandboosterresponsetomenacwyttvaccineafterprimaryvaccinationat110yearsofage
AT nathaliedeschrevel tenyearantibodypersistenceandboosterresponsetomenacwyttvaccineafterprimaryvaccinationat110yearsofage
AT emmanuelaris tenyearantibodypersistenceandboosterresponsetomenacwyttvaccineafterprimaryvaccinationat110yearsofage
AT markcutler tenyearantibodypersistenceandboosterresponsetomenacwyttvaccineafterprimaryvaccinationat110yearsofage
AT pingli tenyearantibodypersistenceandboosterresponsetomenacwyttvaccineafterprimaryvaccinationat110yearsofage
AT johnlperez tenyearantibodypersistenceandboosterresponsetomenacwyttvaccineafterprimaryvaccinationat110yearsofage