title: Persistence of specific bactericidal antibodies at 5 years of age after vaccination against serogroup B meningococcus in infancy and at 40 months.
abstract: BACKGROUND
  The multicomponent serogroup B meningococcal (4CMenB) vaccine induces antibodies against indicator strains of serogroup B meningococcus under various schedules. We investigated the persistence of antibodies in 5-year-old children 18-20 months after their last dose (at about 3.5 years of age).
  
  
  METHODS
  We assessed 5-year-old children who received the 4CMenB vaccine or a recombinant protein vaccine in a previous randomized trial. We also recruited 50 vaccine-naive 5-year-olds and administered 2 doses of 4CMenB to each child. We measured serum bactericidal antibody titres against 4 indicator strains of serogroup B meningococcus matched to each individual vaccine component and against 4 mismatched strains.
  
  
  RESULTS
  Of those who received the 4CMenB vaccine at 2, 4, 6, 12 and 40 months (n = 16), the percentage with protective antibody titres (≥ 1:4) at 60 months ranged from 44% to 88% against matched strains and from 13% to 81% against mismatched strains. Loss of protective titres was also observed for those who received the 4CMenB vaccine at 12, 40 and 42 months (n = 5) (80%-100% against matched strains, 60%-100% against mismatched strains) or at 40 and 42 months (n = 29) (31%-100% against matched strains, 41%-81% against mismatched strains). Administering the 4CMenB vaccine to 5-year-old children yielded protective titres against matched strains in 92%-100% and against mismatched strains in 59%-100%. The majority of these children reported injection-site pain (40/50 [80%] after dose 1, 39/46 [85%] after dose 2) and erythema (47/50 [94%] and 40/46 [87%], respectively); rates of fever were low (5/50 [10%] and 2/46 [4%], respectively).
  
  
  CONCLUSIONS
  Waning of immunity by 5 years of age occurred after receipt of the 4CMenB vaccine in infancy, even with an additional booster at 40 months. The 4CMenB vaccine is immunogenic and was fairly well tolerated by 5-year-old children, although injection-site pain was noteworthy.
  
  
  BACKGROUND
  ClinicalTrials.gov, no. NCT01027351.
authors: Oxford Vaccine Group, Department of Paediatrics (McQuaid, Snape, John, Kelly, Robinson, Pollard), and Nuffield Department of Primary Care Health Sciences (Yu), University of Oxford, Oxford, UK; Oxford Biomedical Research Centre (McQuaid, Snape, John, Kelly, Robinson, Pollard), National Institute for Health Research, Oxford, UK; Novartis Vaccines and Diagnostics S.r.l. (Toneatto), Siena, Italy; Novartis Pharma BV (D'Agostino), Amsterdam, Netherlands; Novartis Vaccines and Diagnostics Inc. (Dull), Cambridge, Mass. fiona.mcquaid@ed.ac.uk.
authors: Fiona
authors: F
authors: McQuaid
authors: Oxford Vaccine Group, Department of Paediatrics (McQuaid, Snape, John, Kelly, Robinson, Pollard), and Nuffield Department of Primary Care Health Sciences (Yu), University of Oxford, Oxford, UK; Oxford Biomedical Research Centre (McQuaid, Snape, John, Kelly, Robinson, Pollard), National Institute for Health Research, Oxford, UK; Novartis Vaccines and Diagnostics S.r.l. (Toneatto), Siena, Italy; Novartis Pharma BV (D'Agostino), Amsterdam, Netherlands; Novartis Vaccines and Diagnostics Inc. (Dull), Cambridge, Mass.
authors: Matthew D
authors: MD
authors: Snape
authors: Oxford Vaccine Group, Department of Paediatrics (McQuaid, Snape, John, Kelly, Robinson, Pollard), and Nuffield Department of Primary Care Health Sciences (Yu), University of Oxford, Oxford, UK; Oxford Biomedical Research Centre (McQuaid, Snape, John, Kelly, Robinson, Pollard), National Institute for Health Research, Oxford, UK; Novartis Vaccines and Diagnostics S.r.l. (Toneatto), Siena, Italy; Novartis Pharma BV (D'Agostino), Amsterdam, Netherlands; Novartis Vaccines and Diagnostics Inc. (Dull), Cambridge, Mass.
authors: Tessa M
authors: TM
authors: John
authors: Oxford Vaccine Group, Department of Paediatrics (McQuaid, Snape, John, Kelly, Robinson, Pollard), and Nuffield Department of Primary Care Health Sciences (Yu), University of Oxford, Oxford, UK; Oxford Biomedical Research Centre (McQuaid, Snape, John, Kelly, Robinson, Pollard), National Institute for Health Research, Oxford, UK; Novartis Vaccines and Diagnostics S.r.l. (Toneatto), Siena, Italy; Novartis Pharma BV (D'Agostino), Amsterdam, Netherlands; Novartis Vaccines and Diagnostics Inc. (Dull), Cambridge, Mass.
authors: Sarah
authors: S
authors: Kelly
authors: Oxford Vaccine Group, Department of Paediatrics (McQuaid, Snape, John, Kelly, Robinson, Pollard), and Nuffield Department of Primary Care Health Sciences (Yu), University of Oxford, Oxford, UK; Oxford Biomedical Research Centre (McQuaid, Snape, John, Kelly, Robinson, Pollard), National Institute for Health Research, Oxford, UK; Novartis Vaccines and Diagnostics S.r.l. (Toneatto), Siena, Italy; Novartis Pharma BV (D'Agostino), Amsterdam, Netherlands; Novartis Vaccines and Diagnostics Inc. (Dull), Cambridge, Mass.
authors: Hannah
authors: H
authors: Robinson
authors: Oxford Vaccine Group, Department of Paediatrics (McQuaid, Snape, John, Kelly, Robinson, Pollard), and Nuffield Department of Primary Care Health Sciences (Yu), University of Oxford, Oxford, UK; Oxford Biomedical Research Centre (McQuaid, Snape, John, Kelly, Robinson, Pollard), National Institute for Health Research, Oxford, UK; Novartis Vaccines and Diagnostics S.r.l. (Toneatto), Siena, Italy; Novartis Pharma BV (D'Agostino), Amsterdam, Netherlands; Novartis Vaccines and Diagnostics Inc. (Dull), Cambridge, Mass.
authors: Ly-Mee
authors: LM
authors: Yu
authors: Oxford Vaccine Group, Department of Paediatrics (McQuaid, Snape, John, Kelly, Robinson, Pollard), and Nuffield Department of Primary Care Health Sciences (Yu), University of Oxford, Oxford, UK; Oxford Biomedical Research Centre (McQuaid, Snape, John, Kelly, Robinson, Pollard), National Institute for Health Research, Oxford, UK; Novartis Vaccines and Diagnostics S.r.l. (Toneatto), Siena, Italy; Novartis Pharma BV (D'Agostino), Amsterdam, Netherlands; Novartis Vaccines and Diagnostics Inc. (Dull), Cambridge, Mass.
authors: Daniela
authors: D
authors: Toneatto
authors: Oxford Vaccine Group, Department of Paediatrics (McQuaid, Snape, John, Kelly, Robinson, Pollard), and Nuffield Department of Primary Care Health Sciences (Yu), University of Oxford, Oxford, UK; Oxford Biomedical Research Centre (McQuaid, Snape, John, Kelly, Robinson, Pollard), National Institute for Health Research, Oxford, UK; Novartis Vaccines and Diagnostics S.r.l. (Toneatto), Siena, Italy; Novartis Pharma BV (D'Agostino), Amsterdam, Netherlands; Novartis Vaccines and Diagnostics Inc. (Dull), Cambridge, Mass.
authors: Diego
authors: D
authors: D'Agostino
authors: Oxford Vaccine Group, Department of Paediatrics (McQuaid, Snape, John, Kelly, Robinson, Pollard), and Nuffield Department of Primary Care Health Sciences (Yu), University of Oxford, Oxford, UK; Oxford Biomedical Research Centre (McQuaid, Snape, John, Kelly, Robinson, Pollard), National Institute for Health Research, Oxford, UK; Novartis Vaccines and Diagnostics S.r.l. (Toneatto), Siena, Italy; Novartis Pharma BV (D'Agostino), Amsterdam, Netherlands; Novartis Vaccines and Diagnostics Inc. (Dull), Cambridge, Mass.
authors: Peter M
authors: PM
authors: Dull
authors: Oxford Vaccine Group, Department of Paediatrics (McQuaid, Snape, John, Kelly, Robinson, Pollard), and Nuffield Department of Primary Care Health Sciences (Yu), University of Oxford, Oxford, UK; Oxford Biomedical Research Centre (McQuaid, Snape, John, Kelly, Robinson, Pollard), National Institute for Health Research, Oxford, UK; Novartis Vaccines and Diagnostics S.r.l. (Toneatto), Siena, Italy; Novartis Pharma BV (D'Agostino), Amsterdam, Netherlands; Novartis Vaccines and Diagnostics Inc. (Dull), Cambridge, Mass.
authors: Andrew J
authors: AJ
authors: Pollard
mesh_terms: D056704:Adaptive Immunity / Q000276:immunology*; D000907:Antibodies, Bacterial / Q000276:immunology*; D002675:Child, Preschool; D005260:Female; D006801:Humans; D008297:Male; D022401:Meningococcal Vaccines / Q000009:adverse effects / Q000276:immunology*; D038541:Neisseria meningitidis, Serogroup B / Q000276:immunology*; D058248:Serum Bactericidal Antibody Assay; D013997:Time Factors
chemical_list: C570015:4CMenB vaccine; D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines