title: Antibody persistence and booster response of a quadrivalent meningococcal conjugate vaccine in adolescents.
abstract: OBJECTIVE
  To evaluate the tolerability and immunogenicity of a booster dose of the quadrivalent meningococcal conjugate vaccine MenACWY-CRM (Menveo, Novartis Vaccines and Diagnostics, Siena, Italy) administered 3 years after primary vaccination of adolescents enrolled in a phase 3 study with either MenACWY-CRM or MenACWY-D (Menactra, Sanofi Pasteur, Swiftwater, Pennsylvania).
  
  
  METHODS
  A total of 730 healthy adolescents participated, including 622 initial study participants who received primary vaccination with MenACWY-CRM (n = 367) or MenACWY-D (n = 255) 3 years previously and 108 age-matched vaccine-naïve controls. A subset of MenACWY-CRM (n = 83) and MenACWY-D (n = 77) recipients were administered a MenACWY-CRM booster dose 3 years postprimary vaccination. Immunogenicity prior to and after the booster dose of MenACWY-CRM was measured by serum bactericidal assay with human complement (hSBA). Local and systemic reactions and adverse events were monitored in subjects receiving the booster dose.
  
  
  RESULTS
  At 3 years postprimary vaccination, 64%, 82%, and 65% of subjects initially vaccinated with MenACWY-CRM (n = 367) showed hSBA titers ≥8 against serogroups C, W-135, and Y, respectively; this was lower for serogroup A (28%). Significantly more MenACWY-CRM recipients had hSBA titers ≥8 for serogroups W-135 and Y than MenACWY-D recipients (n = 255). A MenACWY-CRM booster dose resulted in 99%-100% of subjects demonstrating hSBA titers ≥8 against all serogroups, irrespective of primary vaccination (MenACWY-CRM, n = 83; MenACWY-D, n = 77). The booster dose was well tolerated without significant adverse events.
  
  
  CONCLUSIONS
  MenACWY-CRM can be used to boost adolescents who have received a primary vaccination with either MenACWY-CRM or MenACWY-D.
authors.affiliation: Kaiser Permanente Vaccine Study Center, Oakland, CA. Electronic address: roger.baxter@kp.org.
authors.forename: Roger
authors.initials: R
authors.lastname: Baxter
authors.affiliation: Primary Physicians Research, Pittsburgh, PA.
authors.forename: Keith
authors.initials: K
authors.lastname: Reisinger
authors.affiliation: Kentucky Pediatric and Adult Research, Bardstown, KY.
authors.forename: Stanley L
authors.initials: SL
authors.lastname: Block
authors.affiliation: Novartis Vaccines and Diagnostics, Inc, Cambridge, MA.
authors.forename: Allen
authors.initials: A
authors.lastname: Izu
authors.affiliation: Novartis Vaccines and Diagnostics, Inc, Cambridge, MA.
authors.forename: Tatjana
authors.initials: T
authors.lastname: Odrljin
authors.affiliation: Novartis Vaccines and Diagnostics, Inc, Cambridge, MA.
authors.forename: Peter
authors.initials: P
authors.lastname: Dull
mesh_terms: D000293:Adolescent; D000907:Antibodies, Bacterial / Q000097:blood / Q000276:immunology*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods*; D008297:Male; D008585:Meningitis, Meningococcal / Q000276:immunology / Q000517:prevention & control*; D008589:Meningococcal Infections / Q000276:immunology / Q000517:prevention & control; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D009345:Neisseria meningitidis / Q000276:immunology; D061214:Patient Safety; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome; D014611:Vaccination / Q000379:methods; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000907:Antibodies, Bacterial; C525703:MenACWY; C556088:MenACWY-CRM vaccine; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate