title: Immunogenicity, safety, and tolerability of the meningococcal serogroup B bivalent rLP2086 vaccine in adult laboratory workers.
abstract: BACKGROUND
  The bivalent rLP2086 vaccine is approved in the United States to prevent meningococcal disease caused by Neisseria meningitidis serogroup B (MnB) in individuals aged 10-25 years. The immunogenicity and safety of bivalent rLP2086 were evaluated in microbiologists 24-62 years old who handle MnB.
  
  
  METHODS
  Seven subjects vaccinated at 0, 2, and 6 months had functional antibodies measured before vaccination and 1 month after each dose by serum bactericidal assays using human complement (hSBAs) and 4 vaccine-heterologous MnB test strains.
  
  
  RESULTS
  Six subjects qualified for analysis. All demonstrated hSBA titers ≥the lower limit of quantitation (LLOQ) against 3 of 4 strains; 3 subjects achieved titers ≥LLOQ for the fourth. Safety-related events following vaccination were generally mild to moderate in severity.
  
  
  CONCLUSIONS
  Three doses of bivalent rLP2086 were generally well tolerated in laboratory personnel and elicited protective functional immune responses reflective of broad coverage against MnB disease.
authors.affiliation: Frontage Clinical Research Center, 241 Main Street, 3rd Floor, Hackensack, NJ 07601, USA. Electronic address: David.reiner@bayer.com.
authors.forename: David M
authors.initials: DM
authors.lastname: Reiner
authors.affiliation: Pfizer Vaccine Research, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: Prakash.Bhuyan@pfizer.com.
authors.forename: Prakash
authors.initials: P
authors.lastname: Bhuyan
authors.affiliation: Pfizer Vaccine Research, 401 N Middletown Rd , Pearl River, NY 10965, USA. Electronic address: joseph.eiden@pfizer.com.
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Eiden
authors.affiliation: Pfizer Vaccine Research, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: john.ginis@pfizer.com.
authors.forename: John
authors.initials: J
authors.lastname: Ginis
authors.affiliation: Pfizer Vaccine Research, 401 N Middletown Rd , Pearl River, NY 10965, USA. Electronic address: Shannon.Harris@pfizer.com.
authors.forename: Shannon
authors.initials: S
authors.lastname: Harris
authors.affiliation: Pfizer Vaccine Research, 401 N Middletown Rd , Pearl River, NY 10965, USA. Electronic address: kathrin.jansen@pfizer.com.
authors.forename: Kathrin U
authors.initials: KU
authors.lastname: Jansen
authors.affiliation: Pfizer Vaccine Research, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: qin.jiang@pfizer.com.
authors.forename: Qin
authors.initials: Q
authors.lastname: Jiang
authors.affiliation: Pfizer Vaccine Research, 401 N Middletown Rd , Pearl River, NY 10965, USA. Electronic address: thomas.r.jones@pfizer.com.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Jones
authors.affiliation: Pfizer Vaccine Research, 401 N Middletown Rd , Pearl River, NY 10965, USA. Electronic address: robert.oneill@pfizer.com.
authors.forename: Robert E
authors.initials: RE
authors.lastname: O'Neill
authors.affiliation: Pfizer Medical and Scientific Affairs, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: laura.york@pfizer.com.
authors.forename: Laura J
authors.initials: LJ
authors.lastname: York
authors.affiliation: Pfizer Vaccine Research, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: john.perez@pfizer.com.
authors.forename: John L
authors.initials: JL
authors.lastname: Perez
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D059232:Laboratory Personnel; D008297:Male; D008589:Meningococcal Infections / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000627:therapeutic use*; D008875:Middle Aged; D038541:Neisseria meningitidis, Serogroup B; D012449:Safety; D015610:Serum Bactericidal Test
chemical_list: D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines
keywords: Bivalent rLP2086; Laboratory worker; Meningococcal disease; Neisseria meningitidis; Serogroup B; Vaccine