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Randomized Controlled Trial
. 2013 Oct 15;185(15):E715-24.
doi: 10.1503/cmaj.130257. Epub 2013 Sep 23.

Persistence of bactericidal antibodies following early infant vaccination with a serogroup B meningococcal vaccine and immunogenicity of a preschool booster dose

Matthew D Snape, Praveen Saroey, Tessa M John, Hannah Robinson, Sarah Kelly, Nicoletta Gossger, Ly-Mee Yu, Huajun Wang, Daniela Toneatto, Peter M Dull, Andrew J Pollard
Randomized Controlled Trial

Persistence of bactericidal antibodies following early infant vaccination with a serogroup B meningococcal vaccine and immunogenicity of a preschool booster dose

Matthew D Snape et al. CMAJ. .

Abstract

Background: The multicomponent serogroup B meningococcal (4CMenB) vaccine was recently licensed for use in Europe. There are currently no data on the persistence of bactericidal antibodies induced by use of this vaccine in infants. Our objective was to evaluate serogroup B-specific bactericidal antibodies in children aged 40-44 months previously vaccinated at 2, 4, 6 and 12 months of age.

Methods: Participants given 4 doses of 4CMenB as infants received a fifth dose of the vaccine at 40-44 months of age. Age-matched participants who were MenB vaccine-naive received 4CMenB and formed the control group. We evaluated human complement serum bactericidal activity (hSBA) titres at baseline and 1 month after each dose of 4CMenB.

Results: Before a booster dose at enrolment, 41%-76% of 17 participants previously vaccinated with 4CMenB in infancy had hSBA titres of 4 or greater against 4 reference strains. Before vaccination in the control group (n = 40) these proportions were similar for strains 44/76-SL (63%) and M10713 (68%) but low for strains NZ98/254 (0%) and 5/99 (3%). A booster dose in the 4CMenB-primed participants generated greater increases in hSBA titres than in controls.

Interpretation: As has been observed with other meningococcal vaccines, bactericidal antibodies waned after vaccination with 4CMenB administered according to an approved infant vaccination schedule of 2, 4, 6 and 12 months of age, but there was an anamnestic response to a booster dose at 40-44 months of age. If 4CMenB were introduced into routine vaccination schedules, assessment of the need for a booster dose would require data on the impact of these declining titres on vaccine effectiveness. ClinicalTrials.gov, no. NCT01027351.

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Figures

Figure 1:
Figure 1:
Study design. *Participants who received 4 doses of multicomponent serogroup B meningococcal (4CMenB) vaccine at 2, 4, 6 and 12 months. †Participants who received 4 doses of recombinant protein serogroup B meningococcal (rMenB) vaccine at 2, 4, 6 and 12 months. ‡Participants who received 1 dose of 4CMenB vaccine at 12 months. §Participants who received 1 dose of rMenB vaccine at 12 months. ¶Participants with no previous exposure to 4CMenB or rMenB vaccines.
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References

    1. Summary of opinion: Bexsero. London (UK): European Medicines Agency; 2012. Available: www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initi... (accessed 2013 May 8).
    1. Gossger N, Snape MD, Yu LM, et al. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA 2012;307:573–82 - PubMed
    1. Findlow J, Borrow R, Snape MD, et al. Multicenter, open-label, randomized phase II controlled trial of an investigational recombinant meningococcal serogroup B vaccine with and without outer membrane vesicles, administered in infancy. Clin Infect Dis 2010;51:1127–37 - PubMed
    1. Snape MD, Dawson T, Oster P, et al. Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life: a randomized comparative trial. Pediatr Infect Dis J 2010;29:e71–9 - PubMed
    1. Santolaya ME, O’Ryan ML, Valenzuela MT, et al. Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study. Lancet 2012;379:617–24 - PubMed

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