title: Immunogenicity, Tolerability and Safety in Adolescents of Bivalent rLP2086, a Meningococcal Serogroup B Vaccine, Coadministered with Quadrivalent Human Papilloma Virus Vaccine.
abstract: BACKGROUND
  This study in healthy adolescents (11 to <18 years) evaluated coadministration of quadrivalent human papillomavirus vaccine (HPV-4), with bivalent rLP2086, a meningococcal serogroup B (MnB) vaccine.
  
  
  METHODS
  Subjects received bivalent rLP2086 + HPV-4, bivalent rLP2086 + saline or saline + HPV-4 at 0, 2 and 6 months. Immune responses to HPV-4 antigens were assessed 1 month after doses 2 and 3. Serum bactericidal assays using human complement (hSBAs) with 4 MnB test strains expressing vaccine-heterologous human complement factor H binding protein (fHBP) variants determined immune responses to bivalent rLP2086. Coprimary objectives were to demonstrate noninferior immune responses with concomitant administration compared with either vaccine alone. Additional endpoints included the proportions of subjects achieving prespecified protective hSBA titers to all 4 MnB test strains (composite response) and ≥4-fold increases in hSBA titer from baseline for each test strain after dose 3; these endpoints served as the basis of licensure of bivalent rLP2086 in the US.
  
  
  RESULTS
  The noninferiority criteria were met for all MnB test strains and HPV antigens except HPV-18; ≥99% of subjects seroconverted for all 4 HPV antigens. Bivalent rLP2086 elicited a composite response in >80% of subjects and increased hSBA titers ≥4-fold in ≥77% of subjects for each test strain after dose 3. A substantial bactericidal response was also observed in a large proportion of subjects after dose 2. Local reactions and systemic events did not increase with concomitant administration.
  
  
  CONCLUSIONS
  Concomitant administration of bivalent rLP2086 and HPV-4 elicits robust immune responses to both vaccines without increasing reactogenicity compared with bivalent rLP2086 alone. Concurrent administration may increase compliance with both vaccine schedules.
authors.affiliation: From the *Senders Pediatrics, Cleveland, OH; †Pfizer Vaccine Clinical Research, Collegeville, PA; ‡Pfizer Vaccine Clinical Research, Pearl River, NY; §Pfizer Vaccine Research Operations and Strategy, Pearl River, NY; ¶Pfizer Medical and Scientific Affairs, Collegeville, PA; and ‖Pfizer Vaccine Research and Development, Pearl River, NY.
authors.forename: Shelly
authors.initials: S
authors.lastname: Senders
authors.forename: Prakash
authors.initials: P
authors.lastname: Bhuyan
authors.forename: Qin
authors.initials: Q
authors.lastname: Jiang
authors.forename: Judith
authors.initials: J
authors.lastname: Absalon
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Eiden
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Jones
authors.forename: Laura J
authors.initials: LJ
authors.lastname: York
authors.forename: Kathrin U
authors.initials: KU
authors.lastname: Jansen
authors.forename: Robert E
authors.initials: RE
authors.lastname: O'Neill
authors.forename: Shannon L
authors.initials: SL
authors.lastname: Harris
authors.forename: John
authors.initials: J
authors.lastname: Ginis
authors.forename: John L
authors.initials: JL
authors.lastname: Perez
mesh_terms: D000293:Adolescent; D000942:Antigens, Bacterial / Q000276:immunology; D001426:Bacterial Proteins / Q000276:immunology; D001770:Blood Bactericidal Activity; D002648:Child; D003165:Complement System Proteins / Q000276:immunology; D005260:Female; D064368:Healthy Volunteers; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D008297:Male; D008589:Meningococcal Infections / Q000382:microbiology / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D038541:Neisseria meningitidis, Serogroup B / Q000276:immunology; D030361:Papillomavirus Infections / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000942:Antigens, Bacterial; D001426:Bacterial Proteins; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D022401:Meningococcal Vaccines; C484699:factor H-binding protein, Neisseria meningitidis; D003165:Complement System Proteins