title: Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) in healthy Korean adolescents and adults.
abstract: OBJECTIVE
  This phase III placebo-controlled study evaluated the immunogenicity and safety of MenACWY-CRM vaccination in healthy Korean adolescents and adults.
  
  
  METHODS
  Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination against all four meningococcal serogroups. The IgG concentration specific for serogroup W capsular polysaccharide was measured in a subset of subjects in a post-hoc analysis. Adverse reactions were monitored throughout the study.
  
  
  RESULTS
  Four hundred and fifty subjects were randomized 2:1 to receive MenACWY-CRM (N=297) or a saline placebo (N=153). MenACWY-CRM induced a good immune response against all four serogroups, with seroprotection rates (hSBA titers ≥8) of 79%, 99%, 98%, and 94% for serogroups A, C, W, and Y, respectively. Seroresponse rates were high for serogroups A, C, and Y, i.e. 76%, 86%, and 69%, respectively; the rate for serogroup W was 28%. MenACWY-CRM vaccine induced serum bactericidal antibodies against all four serogroups in a majority of subjects regardless of their baseline hSBA titers. MenACWY-CRM was generally well tolerated with most reactions being transient and mild to moderate in severity.
  
  
  CONCLUSIONS
  Findings of this first study of a quadrivalent meningococcal polysaccharide conjugate vaccine in Korean adults and adolescents demonstrated that a single dose of MenACWY-CRM was well tolerated and immunogenic, as indicated by the percentages of subjects with hSBA titers ≥8 (79%, 99%, 98%, and 94% of subjects) and geometric mean titers (48, 231, 147, and 107) against serogroups A, C, W, and Y, respectively, at 1 month post-vaccination.
authors.affiliation: Seoul National University Children's Hospital, 101 Daehak-ro, Jongno-gu, Seoul 110-769, Korea; Seoul National University College of Medicine, Seoul, Korea. Electronic address: hoanlee@snu.ac.kr.
authors.forename: Hoan Jong
authors.initials: HJ
authors.lastname: Lee
authors.affiliation: Inha University Hospital, Incheon, Korea.
authors.forename: Moon-Hyun
authors.initials: MH
authors.lastname: Chung
authors.affiliation: Korea University Guro Hospital, Seoul, Korea.
authors.forename: Woo Joo
authors.initials: WJ
authors.lastname: Kim
authors.affiliation: Inha University Hospital, Incheon, Korea.
authors.forename: Young Jin
authors.initials: YJ
authors.lastname: Hong
authors.affiliation: Myongji Hospital, Kwandong University College of Medicine, Koyang, Korea.
authors.forename: Kyong Min
authors.initials: KM
authors.lastname: Choi
authors.affiliation: Seoul National University Bundang Hospital, Seongnam, Korea.
authors.forename: Jina
authors.initials: J
authors.lastname: Lee
authors.affiliation: Kosin University College of Medicine, Busan, Korea.
authors.forename: Chi Eun
authors.initials: CE
authors.lastname: Oh
authors.affiliation: Novartis Vaccines and Diagnostics, Cambridge, Massachusetts, USA.
authors.forename: Jo Anne
authors.initials: JA
authors.lastname: Welsch
authors.affiliation: Ewha Womans University School of Medicine, Seoul, Korea.
authors.forename: Kyung-Hyo
authors.initials: KH
authors.lastname: Kim
authors.affiliation: Seoul National University Children's Hospital, 101 Daehak-ro, Jongno-gu, Seoul 110-769, Korea.
authors.forename: Ki Bae
authors.initials: KB
authors.lastname: Hong
authors.affiliation: Novartis Vaccines and Diagnostics, Cambridge, Massachusetts, USA.
authors.forename: Alemnew F
authors.initials: AF
authors.lastname: Dagnew
authors.affiliation: Novartis Vaccines and Diagnostics, Cambridge, Massachusetts, USA.
authors.forename: Hans
authors.initials: H
authors.lastname: Bock
authors.affiliation: Novartis Vaccines and Diagnostics, Cambridge, Massachusetts, USA.
authors.forename: Peter M
authors.initials: PM
authors.lastname: Dull
authors.affiliation: Novartis Vaccines and Diagnostics, Cambridge, Massachusetts, USA.
authors.forename: Tatjana
authors.initials: T
authors.lastname: Odrljin
mesh_terms: D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D022401:Meningococcal Vaccines / Q000009:adverse effects* / Q000276:immunology*; D008875:Middle Aged; D009345:Neisseria meningitidis / Q000276:immunology; D065288:Serogroup; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; C556088:MenACWY-CRM vaccine; D022401:Meningococcal Vaccines
keywords: Conjugate vaccines; Korea; Neisseria meningitidis; Quadrivalent meningococcal vaccine