title: Persistence of the immune response two years after vaccination with quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine (MenACWY-TT) in Asian adolescents.
abstract: Invasive meningococcal disease is a serious infection that is most often vaccine-preventable. Long-term protection relies on antibody persistence. Here we report the persistence of the immune response 2 y post-vaccination with a quadrivalent meningococcal serogroups A, C, W, Y tetanus toxoid conjugate vaccine (MenACWY-TT) compared with a MenACWY polysaccharide vaccine (Men-PS), in Asian adolescents aged 11-17 y. We also report a re-analysis of data from the primary vaccination study. This persistence study (NCT00974363) conducted in India and the Philippines included subjects who previously (study NCT00464815) received a single dose of MenACWY-TT or Men-PS. Persistence of functional antibodies was measured in 407 MenACWY-TT recipients and 132 Men-PS recipients (according-to-protocol cohort) using a rabbit complement serum bactericidal assay (rSBA, cut-off 1:8). Vaccine-related serious adverse events (SAEs) occurring since the end of the initial vaccination study were retrospectively recorded. Two y post-vaccination ≥99.3% of adolescents who received MenACWY-TT had persisting antibody titers ≥1:8 against each vaccine serogroup. Antibody persistence was higher (exploratory analysis) in the MenACWY-TT group than the Men-PS group in terms of rSBA titers ≥1:8 for serogroups W and Y; rSBA titers ≥1:128 for serogroups A, W and Y; and rSBA GMTs for serogroups A, W and Y; and was lower in the MenACWY-TT group for rSBA GMTs for serogroup C. No vaccine-related SAEs were reported. The results of this study indicated that antibodies persisted for at least 2 y in the majority of adolescents after vaccination with a single dose of MenACWY-TT.
authors.affiliation: a Clinical Research Division, Research Institute for Tropical Medicine , Alabang, Muntinlupa City , Philippines.
authors.forename: Beatriz P
authors.initials: BP
authors.lastname: Quiambao
authors.affiliation: b Chacha Nehru Hospital , Indore , India.
authors.forename: Hermant
authors.initials: H
authors.lastname: Jain
authors.affiliation: c K.E.M Hospital , Pune , Maharashtra , India.
authors.forename: Ashish
authors.initials: A
authors.lastname: Bavdekar
authors.affiliation: d Department of Pediatrics , Maulana Azad Medical College (MAMC), and Associated Lok Nayak Hospital , New Delhi , India.
authors.forename: Anand Prakash
authors.initials: AP
authors.lastname: Dubey
authors.affiliation: e GSK Vaccines, Bangalore, India; Wavre, Belgium; and King of Prussia , PA , USA.
authors.forename: Devayani
authors.initials: D
authors.lastname: Kolhe
authors.affiliation: e GSK Vaccines, Bangalore, India; Wavre, Belgium; and King of Prussia , PA , USA.
authors.forename: Véronique
authors.initials: V
authors.lastname: Bianco
authors.affiliation: e GSK Vaccines, Bangalore, India; Wavre, Belgium; and King of Prussia , PA , USA.
authors.forename: Marie
authors.initials: M
authors.lastname: Van der Wielen
authors.affiliation: e GSK Vaccines, Bangalore, India; Wavre, Belgium; and King of Prussia , PA , USA.
authors.forename: Jacqueline M
authors.initials: JM
authors.lastname: Miller
mesh_terms: D000293:Adolescent; D001770:Blood Bactericidal Activity; D002648:Child; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D015994:Incidence; D007194:India; D008297:Male; D008589:Meningococcal Infections / Q000276:immunology* / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D010679:Philippines; D012189:Retrospective Studies
chemical_list: D022401:Meningococcal Vaccines; C576777:tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine
keywords: Neisseria meningitidis; adolescents; conjugate vaccine; immunogenicity; persistence; quadrivalent meningococcal vaccine