Evidence map›Paper›PMID 25802309›Full record

Trial reportCMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne2015

Persistence of specific bactericidal antibodies at 5 years of age after vaccination against serogroup B meningococcus in infancy and at 40 months.

Fiona McQuaid, Matthew D Snape, Tessa M John, Sarah Kelly, Hannah Robinson, Ly-Mee Yu, Daniela Toneatto, Diego D'Agostino, Peter M Dull, Andrew J Pollard

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01027351 (A Phase 2, Open-Label, Single-Center, Extension Study Evaluating Antibody Persistence Compared to Naïve Children and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Novartis Vaccine as Infants in Study V72P6), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
4.8field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01027351 phase2completednot on this map

A Phase 2, Open-Label, Single-Center, Extension Study Evaluating Antibody Persistence Compared to Naïve Children and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Novartis Vaccine as Infants in Study V72P6

TypeinterventionalSponsorNovartis VaccinesRan2010 to 2012Enrolled163ConditionsMeningococcal DiseaseArmsMeningococcal (group B) multicomponent recombinant adsorbed vaccine., Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 34 citations in OpenAlex.

  1. Persistence of immunity after vaccination with a capsular group B meningococcal vaccine in 3 different toddler schedules.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2017
    Trial
  2. Review
  3. Article
  4. Product review on the IMD serogroup B vaccine Bexsero®.Human vaccines & immunotherapeutics · 2022
    Article
  5. Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Are physicians obligated to tell parents about the meningococcal serogroup B vaccine?The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 3 countries.

Fiona McQuaidOxford 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.
Matthew D SnapeOxford 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.
Tessa M JohnOxford 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.
Sarah KellyOxford 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.
Hannah RobinsonOxford 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.
Ly-Mee YuOxford 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.
Daniela ToneattoOxford 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.
Diego D'AgostinoOxford 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.
Peter M DullOxford 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.
Andrew J PollardOxford 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.
National Institute for Health Research · GBNovartis (Netherlands) · NLNovartis (Italy) · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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).

methodsWe 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.

resultsOf 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).

interpretationWaning 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.

trial registrationClinicalTrials.gov, no. NCT01027351.

Indexed as

Adaptive ImmunityAntibodies, BacterialChild, PreschoolFemaleHumansMaleMeningococcal VaccinesNeisseria meningitidis, Serogroup BSerum Bactericidal Antibody AssayTime Factors4CMenB vaccineAntibodies, BacterialMeningococcal Vaccines

Identifiers

PMID25802309
PMCPMC4401613
OpenAlexW2119283188

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.