Antibody persistence and booster response 68 months after vaccination at 2–10 years of age with one dose of MenACWY-TT conjugate vaccine. Issue 23 (31st May 2018)

• Record Type: Journal Article
• Authors: Knuf, Markus; Helm, Klaus; Kolhe, Devayani; Van Der Wielen, Marie; Baine, Yaela
• Is Part Of: Vaccine. Volume 36:Issue 23(2018)
• Page Start: 3286
• Page End: 3295
• Publication Date: 2018-05-31
• Subjects: AEs adverse events -- ATP according-to-protocol -- CIs confidence intervals -- GI gastrointestinal -- GMTs geometric mean titers -- hSBA serum bactericidal activity assay using human complement -- IMD invasive meningococcal disease -- M month -- MenB meningococcal serogroup B -- MenC meningococcal serogroup C -- MenACWY-TT quadrivalent meningococcal serogroups A, C, W and Y tetanus toxoid conjugate vaccine -- MenC-CRM monovalent MenC conjugate vaccine -- NOCI new onset of chronic illness -- rSBA serum bactericidal assay using rabbit complement -- SAEs serious adverse events -- TT tetanus toxoid -- TVC total vaccinated cohort; Quadrivalent meningococcal vaccine -- Conjugate vaccine -- Antibody persistence -- Booster response -- Children; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2018.04.064
• Languages: English
• ISSNs: 0264-410X

Abstract

Abstract: Background: We evaluated antibody persistence up to 68 months (M) post-vaccination with a quadrivalent meningococcal serogroups A, C, W and Y tetanus toxoid conjugate vaccine (MenACWY-TT) or a licensed monovalent MenC conjugate vaccine (MenC-CRM197 ) and subsequent booster responses to MenACWY-TT in healthy European children. Methods: In the initial study (NCT00674583), healthy children, 2–10 years of age, were randomized to receive a single dose of either MenACWY-TT or MenC-CRM197 . In the follow-up study, we present the persistence at 32, 44, 56, and 68 M post-vaccination, overall and stratified by age (2–5 and 6–10 years), and the immunogenicity and safety of MenACWY-TT administered to all study participants at M68 post-primary vaccination. Results: At M68, 33.3% (age group 2–5 years) and 47.1% (age group 6–10 years) of the children vaccinated with MenACWY-TT, and 50.0% (age group 2–5 years) and 75.9% (age group 6–10 years) vaccinated with MenC-CRM197 retained titers ≥1:8 for MenC, as assessed by a serum bactericidal assay using rabbit complement (rSBA). In the MenACWY-TT recipients, the percentages of children retaining rSBA titers ≥1:8 for MenA, MenW, and MenY were 81.7%, 47.3% and 66.7% in age group 2–5 years and 91.8%, 58, 8% and 76.5% in age group 6–10 years, respectively. The booster dose induced robust responses (100% for all serogroups) and was well-tolerated. Conclusions: Antibody persistence (rSBA titers ≥ 1:8) for serogroups A, W and Y was observed in more than 50.0% of the children 68 M after receiving one dose of MenACWY-TT; for MenC, antibody persistence was observed in more than one third of MenACWY-TT and more than half of MenC-CRM197 recipients. Vaccination with a booster dose of MenACWY-TT induced robust immune responses for all serogroups.