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...
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Format: | Article |
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Taylor & Francis Group
2020-06-01
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Series: | Human Vaccines & Immunotherapeutics |
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Online Access: | http://dx.doi.org/10.1080/21645515.2020.1746110 |
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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 |
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issn | 2164-5515 2164-554X |
language | English |
last_indexed | 2024-03-11T22:43:02Z |
publishDate | 2020-06-01 |
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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 |
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