title: Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life: a randomized comparative trial.
abstract: BACKGROUND
  An investigational vaccine against serogroup B meningococcal (MenB) disease containing 3 main recombinant proteins (factor H-binding protein, Neisserial adhesion A, and Neisserial heparin-binding antigen) has been developed. We evaluated the immunogenicity and reactogenicity of a 3-dose course of this vaccine administered alone (recombinant MenB [rMenB]) or combined with the outer membrane vesicle (OMV) component of the vaccine used in New Zealand (rMenB+OMV).
  
  
  METHODS
  A randomized, single-blind, comparative study of 60 healthy infants enrolled at 6 to 8 months of age and immunized with rMenB or rMenB+OMV at day 0, day 60, and at age 12 months. Blood samples obtained at baseline and 1 month following the second and third doses of vaccine were analyzed for serum bactericidal antibody (SBA) using human complement (hSBA) against 7 MenB strains. The putative correlate of protection was an hSBA titer of ≥4.
  
  
  RESULTS
  The per-protocol analysis included 24 of 30 participants randomized to each group. After 3 doses of rMenB+OMV, 90% or more of participants had an hSBA titer ≥4 for 5 MenB strains, with 70% of participants having an hSBA titer ≥4 for a sixth strain. rMenB alone was immunogenic for only 3 strains. Both vaccines were well tolerated.
  
  
  CONCLUSIONS
  Three doses of rMenB+OMV in the second half of infancy induce bactericidal antibodies against strains expressing vaccine antigens, demonstrating the potential for broader vaccine prevention of MenB disease. This vaccine is now in phase III clinical trials.
authors.affiliation: Department of Paediatrics, Oxford Vaccine Group, University of Oxford, Oxford, United Kingdom. matthew.snape@paediatrics.ox.ac.uk
authors.forename: Matthew D
authors.initials: MD
authors.lastname: Snape
authors.forename: Tom
authors.initials: T
authors.lastname: Dawson
authors.forename: Philipp
authors.initials: P
authors.lastname: Oster
authors.forename: Anita
authors.initials: A
authors.lastname: Evans
authors.forename: Tessa M
authors.initials: TM
authors.lastname: John
authors.forename: Brigitte
authors.initials: B
authors.lastname: Ohene-Kena
authors.forename: Jamie
authors.initials: J
authors.lastname: Findlow
authors.forename: Ly-Mee
authors.initials: LM
authors.lastname: Yu
authors.forename: Ray
authors.initials: R
authors.lastname: Borrow
authors.forename: Ellen
authors.initials: E
authors.lastname: Ypma
authors.forename: Daniela
authors.initials: D
authors.lastname: Toneatto
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Pollard
mesh_terms: D018829:Adhesins, Bacterial / Q000276:immunology; D000704:Analysis of Variance; D000907:Antibodies, Bacterial / Q000097:blood; D000942:Antigens, Bacterial / Q000276:immunology; D001425:Bacterial Outer Membrane Proteins / Q000276:immunology*; D001426:Bacterial Proteins / Q000276:immunology; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007074:Immunoglobulin G / Q000097:blood; D007223:Infant; D008297:Male; D008585:Meningitis, Meningococcal / Q000276:immunology / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D038541:Neisseria meningitidis, Serogroup B / Q000276:immunology*; D058248:Serum Bactericidal Antibody Assay; D016037:Single-Blind Method
chemical_list: D018829:Adhesins, Bacterial; D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D001425:Bacterial Outer Membrane Proteins; D001426:Bacterial Proteins; D007074:Immunoglobulin G; D022401:Meningococcal Vaccines; C501982:NadA protein, Neisseria meningitidis; C484699:factor H-binding protein, Neisseria meningitidis