title: Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine in healthy adolescents in Korea--A randomised trial.
abstract: BACKGROUND
  Neisseria meningitidis serogroup B is a significant cause of septicaemia and meningitis worldwide. This phase 3 randomised, controlled study assessed the immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in healthy Korean adolescents.
  
  
  METHODS
  264 adolescents (11-17 years old) were randomised to receive two doses, one month apart, of 4CMenB or control vaccines [placebo followed by one dose of a quadrivalent meningococcal ACWY glycoconjugate vaccine (MenACWY-CRM)]. Immunogenicity was evaluated by serum bactericidal assay with human complement (hSBA) against three serogroup B test strains specific for individual vaccine antigens (fHbp, NadA or PorA P1.4), and by enzyme-linked immunosorbent assay (ELISA) against the NHBA antigen. Solicited reactions and adverse events (AEs) were assessed.
  
  
  RESULTS
  One month post-second vaccination, 98%, 97%, and 97% of subjects in the 4CMenB group achieved hSBA titres ≥ 4 against the fHbp, NadA and PorA test strains, respectively, while percentages in the Control group were comparable to baseline (27%, 16%, and 17%, respectively). Geometric mean ELISA concentrations (GMCs) against NHBA increased 52-fold relative to baseline in the 4CMenB group, while there was no substantial increase in GMCs in the Control group (1.05-fold). Frequencies of solicited reactions after any vaccination were higher in the 4CMenB group than in the Control group, although most reactions were of short duration and mild to moderate intensity. There were no vaccine-related serious AEs.
  
  
  CONCLUSIONS
  Two doses of 4CMenB induced robust immune responses against the vaccine antigens and were well tolerated, with no safety concerns identified, in Korean adolescents (NCT01973218).
authors.affiliation: Seoul National University Children's Hospital, Seoul National College of Medicine, Seoul, South Korea.
authors.forename: Hoan Jong
authors.initials: HJ
authors.lastname: Lee
authors.affiliation: Seoul National University Children's Hospital, Seoul National College of Medicine, Seoul, South Korea.
authors.forename: Young June
authors.initials: YJ
authors.lastname: Choe
authors.affiliation: Inha University Hospital, Incheon, South Korea.
authors.forename: Young-Jin
authors.initials: YJ
authors.lastname: Hong
authors.affiliation: Ewha Womans University Mokdong Hospital, Seoul, South Korea.
authors.forename: Kyung-Hyo
authors.initials: KH
authors.lastname: Kim
authors.affiliation: Pusan National University Children's Hospital, Yangsan, South Korea.
authors.forename: Su Eun
authors.initials: SE
authors.lastname: Park
authors.affiliation: Korea University Ansan Hospital, Seoul, South Korea.
authors.forename: Yun-Kyung
authors.initials: YK
authors.lastname: Kim
authors.affiliation: Kosin University Gospel Hospital, Busan, South Korea.
authors.forename: Chi-Eun
authors.initials: CE
authors.lastname: Oh
authors.affiliation: Seoul National University Bundang Hospital, Seongnam, South Korea.
authors.forename: Hyunju
authors.initials: H
authors.lastname: Lee
authors.affiliation: GlaxoSmithKline Korea Ltd, Seoul, South Korea.
authors.forename: Hyoyoung
authors.initials: H
authors.lastname: Song
authors.affiliation: Novartis Asia Pacific Pharmaceuticals Ptd Ltd, Singapore, Singapore.
authors.forename: Hans
authors.initials: H
authors.lastname: Bock
authors.affiliation: Novartis Vaccines and Diagnostics, S.R.L.-A GSK Company, Siena, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Casula
authors.affiliation: Novartis Vaccines and Diagnostics, S.R.L.-A GSK Company, Siena, Italy.
authors.forename: Chiranjiwi
authors.initials: C
authors.lastname: Bhusal
authors.affiliation: Novartis Vaccines and Diagnostics, S.R.L.-A GSK Company, Siena, Italy. Electronic address: ashwani.k.arora@gsk.com.
authors.forename: Ashwani Kumar
authors.initials: AK
authors.lastname: Arora
mesh_terms: D000293:Adolescent; D000907:Antibodies, Bacterial / Q000097:blood; D002648:Child; D003165:Complement System Proteins / Q000276:immunology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D008297:Male; D008589:Meningococcal Infections / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000276:immunology / Q000627:therapeutic use*; D038541:Neisseria meningitidis, Serogroup B; D056910:Republic of Korea; D058248:Serum Bactericidal Antibody Assay; D016037:Single-Blind Method; D018074:Vaccines, Conjugate / Q000276:immunology / Q000627:therapeutic use
chemical_list: C570015:4CMenB vaccine; D000907:Antibodies, Bacterial; C525703:MenACWY; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate; D003165:Complement System Proteins
keywords: 4CMenB vaccine; Adolescents; Korea; Neisseria meningitidis; Serogroup B