title: Meningococcal Serogroup B Bivalent rLP2086 Vaccine Elicits Broad and Robust Serum Bactericidal Responses in Healthy Adolescents.
abstract: Neisseria meningitidis serogroup B (MnB) is a leading cause of invasive meningococcal disease in adolescents and young adults. A recombinant factor H binding protein (fHBP) vaccine (Trumenba(®); bivalent rLP2086) was recently approved in the United States in individuals aged 10-25 years. Immunogenicity and safety of 2- or 3-dose schedules of bivalent rLP2086 were assessed in adolescents.
  
  
  
  Healthy adolescents (11 to <19 years) were randomized to 1 of 5 bivalent rLP2086 dosing regimens (0,1,6-month; 0,2,6-month; 0,2-month; 0,4-month; 0,6-month). Immunogenicity was assessed by serum bactericidal antibody assay using human complement (hSBA). Safety assessments included local and systemic reactions and adverse events.
  
  
  
  Bivalent rLP2086 was immunogenic when administered as 2 or 3 doses; the most robust hSBA responses occurred with 3 doses. The proportion of subjects with hSBA titers ≥1:8 after 3 doses ranged from 91.7% to 95.0%, 98.9% to 99.4%, 88.4% to 89.0%, and 86.1% to 88.5% for MnB test strains expressing vaccine--heterologous fHBP variants A22, A56, B24, and B44, respectively. After 2 doses, responses ranged from 90.8% to 93.5%, 98.4% to 100%, 69.1% to 81.1%, and 70.1% to 77.5%. Geometric mean titers (GMTs) were highest among subjects receiving 3 doses and similar between the 2- and 3-dose regimens. After 2 doses, GMTs trended numerically higher among subjects with longer intervals between the first and second dose (6 months vs 2 and 4 months). Bivalent rLP2086 was well tolerated.
  
  
  
  Bivalent rLP2086 was immunogenic and well tolerated when administered in 2 or 3 doses. Three doses yielded the most robust hSBA response rates against MnB strains expressing vaccine-heterologous subfamily B fHBPs.
authors.affiliation: University of Tampere Medical School, Finland.
authors.forename: Timo
authors.initials: T
authors.lastname: Vesikari
authors.affiliation: Department of Infectious Diseases, Aarhus University Hospital, Denmark.
authors.forename: Lars
authors.initials: L
authors.lastname: Østergaard
authors.affiliation: Área de Investigación en Vacunas, FISABIO-Public Health, Universidad Católica de Valencia, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Diez-Domingo
authors.affiliation: Department of Preventive Medicine, Poznań University of Medical Sciences, Poland.
authors.forename: Jacek
authors.initials: J
authors.lastname: Wysocki
authors.affiliation: Vaccine Unit, Department of Pediatrics, Skåne University Hospital, Malmo, Sweden.
authors.forename: Carl-Erik
authors.initials: CE
authors.lastname: Flodmark
authors.affiliation: Pfizer Ltd, Walton Oaks, Tadworth, United Kingdom.
authors.forename: Johannes
authors.initials: J
authors.lastname: Beeslaar
authors.affiliation: Pfizer Vaccine Research, Pearl River, New York.
authors.forename: Joseph
authors.initials: J
authors.lastname: Eiden
authors.affiliation: Pfizer Global Vaccines, Collegeville, Pennsylvania.
authors.forename: Qin
authors.initials: Q
authors.lastname: Jiang
authors.affiliation: Pfizer Vaccine Research, Pearl River, New York.
authors.forename: Kathrin U
authors.initials: KU
authors.lastname: Jansen
authors.affiliation: Pfizer Vaccine Research, Pearl River, New York.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Jones
authors.affiliation: Pfizer Vaccine Research, Pearl River, New York.
authors.forename: Shannon L
authors.initials: SL
authors.lastname: Harris
authors.affiliation: Pfizer Vaccine Research, Pearl River, New York.
authors.forename: Robert E
authors.initials: RE
authors.lastname: O'Neill
authors.affiliation: Pfizer Medical and Scientific Affairs, Collegeville, Pennsylvania.
authors.forename: Laura J
authors.initials: LJ
authors.lastname: York
authors.affiliation: Pfizer Ltd, Walton Oaks, Tadworth, United Kingdom.
authors.forename: Graham
authors.initials: G
authors.lastname: Crowther
authors.affiliation: Pfizer Global Vaccines, Collegeville, Pennsylvania.
authors.forename: John L
authors.initials: JL
authors.lastname: Perez
mesh_terms: D000293:Adolescent; D000907:Antibodies, Bacterial / Q000097:blood; D000917:Antibody Formation; D000942:Antigens, Bacterial; D001426:Bacterial Proteins; D005260:Female; D006801:Humans; D000071497:Immunogenicity, Vaccine; D008297:Male; D008589:Meningococcal Infections / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000627:therapeutic use*; D038541:Neisseria meningitidis, Serogroup B; D058248:Serum Bactericidal Antibody Assay; D014614:Vaccines, Synthetic / Q000627:therapeutic use
chemical_list: D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D001426:Bacterial Proteins; D022401:Meningococcal Vaccines; D014614:Vaccines, Synthetic
keywords: Neisseria meningitidis serogroup B; bivalent rLP2086; clinical trial; functional immunogenicity; safety