title: Bactericidal antibody against a representative epidemiological meningococcal serogroup B panel confirms that MATS underestimates 4CMenB vaccine strain coverage.
abstract: BACKGROUND
  4CMenB (Bexsero), a vaccine developed against invasive meningococcal disease caused by capsular group B strains (MenB), was recently licensed for use by the European Medicines Agency. Assessment of 4CMenB strain coverage in specific epidemiologic settings is of primary importance to predict vaccination impact on the burden of disease. The Meningococcal Antigen Typing System (MATS) was developed to predict 4CMenB strain coverage, using serum bactericidal antibody assay with human complement (hSBA) data from a diverse panel of strains not representative of any specific epidemiology.
  
  
  OBJECTIVE
  To experimentally validate the accuracy of MATS-based predictions against strains representative of a specific epidemiologic setting.
  
  
  RESULTS
  We used a stratified sampling method to identify a representative sample from all MenB disease isolates collected from England and Wales in 2007-2008, tested the strains in the hSBA assay with pooled sera from infant and adolescent vaccinees, and compared these results with MATS. MATS predictions and hSBA results were significantly associated (P=0.022). MATS predicted coverage of 70% (95% CI, 55-85%) was largely confirmed by 88% killing in the hSBA (95% CI, 72-95%). MATS had 78% accuracy and 96% positive predictive value against hSBA.
  
  
  CONCLUSIONS
  MATS is a conservative predictor of strain coverage by the 4CMenB vaccine in infants and adolescents.
authors: Research Center, Novartis Vaccines and Diagnostics, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: giacomo.frosi@libero.it.
authors: Giacomo
authors: G
authors: Frosi
authors: Alessia
authors: A
authors: Biolchi
authors: Morena
authors: M
authors: Lo Sapio
authors: Fabio
authors: F
authors: Rigat
authors: Stefanie
authors: S
authors: Gilchrist
authors: Jay
authors: J
authors: Lucidarme
authors: Jamie
authors: J
authors: Findlow
authors: Ray
authors: R
authors: Borrow
authors: Mariagrazia
authors: M
authors: Pizza
authors: Marzia Monica
authors: MM
authors: Giuliani
authors: Duccio
authors: D
authors: Medini
mesh_terms: D000293:Adolescent; D000907:Antibodies, Bacterial / Q000097:blood*; D000942:Antigens, Bacterial / Q000276:immunology*; D002648:Child; D002675:Child, Preschool; D004739:England / Q000453:epidemiology; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007223:Infant; D008297:Male; D008589:Meningococcal Infections / Q000453:epidemiology / Q000382:microbiology / Q000517:prevention & control; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D038541:Neisseria meningitidis, Serogroup B / Q000276:immunology*; D011237:Predictive Value of Tests; D058248:Serum Bactericidal Antibody Assay / Q000379:methods*; D014611:Vaccination / Q000706:statistics & numerical data*; D014852:Wales / Q000453:epidemiology
chemical_list: C570015:4CMenB vaccine; D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D022401:Meningococcal Vaccines
keywords: 4CMenB vaccine strain coverage; CC; ELISA; FN; FP; HPA; Health Protection Agency; IMD; MATS; MLST; MenB; Meningococcal Antigen Typing System; NHBA; NadA; Neisseria meningitidis serogroup B; Neisserial adhesin A; Neisserial heparin binding antigen; OMV; PBT; PorA; RP; SBA; ST; Serum bactericidal antibody assay; Stratified proportional sampling; TN; TP; capsular group B meningococcus; clonal complex; enzyme-linked immunosorbent assay; fHBP; factor H binding protein; false negatives; false positives; hSBA; invasive meningococcal disease; multilocus sequence typing; outer membrane vesicle; porin A; positive bactericidal threshold; relative potency; sequence type; serum bactericidal antibody; serum bactericidal antibody assay with human complement; true negatives; true positives