Elsevier

Journal of Infection

Volume 76, Issue 3, March 2018, Pages 258-269
Journal of Infection

Antibody persistence and booster responses 24–36 months after different 4CMenB vaccination schedules in infants and children: A randomised trial

https://doi.org/10.1016/j.jinf.2017.12.005Get rights and content
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open access

Highlights

  • A reduced 2 + 1 and a licensed 3 + 1 4CMenB-schedule in infants result in similar antibody persistence.

  • Two catch-up doses for 2–10-year-olds induced adequate priming of antibody for 2–3 years.

  • A booster dose after 2 + 1 or 3 + 1 vaccination elicited similarly high hSBA titres.

  • An accelerated schedule (in vaccine-naïve) induced an early immune response after first dose.

  • No safety concerns arose for either schedule.

Abstract

Objectives

This phase IIIb, open-label, multicentre, extension study (NCT01894919) evaluated long-term antibody persistence and booster responses in participants who received a reduced 2 + 1 or licensed 3 + 1 meningococcal serogroup B vaccine (4CMenB)-schedule (infants), or 2-dose catch-up schedule (2–10-year-olds) in parent study NCT01339923.

Materials and methods

Children aged 35 months to 12 years (N = 851) were enrolled. Follow-on participants (N = 646) were randomised 2:1 to vaccination and non-vaccination subsets; vaccination subsets received an additional 4CMenB dose. Newly enrolled vaccine-naïve participants (N = 205) received 2 catch-up doses, 1 month apart (accelerated schedule). Antibody levels were determined using human serum bactericidal assay (hSBA) against MenB indicator strains for fHbp, NadA, PorA and NHBA. Safety was also evaluated.

Results

Antibody levels declined across follow-on groups at 24–36 months versus 1 month post-vaccination. Antibody persistence and booster responses were similar between infants receiving the reduced or licensed 4CMenB-schedule. An additional dose in follow-on participants induced higher hSBA titres than a first dose in vaccine-naïve children. Two catch-up doses in vaccine-naïve participants induced robust antibody responses. No safety concerns were identified.

Conclusion

Antibody persistence, booster responses, and safety profiles were similar with either 2 + 1 or 3 + 1 vaccination schedules. The accelerated schedule in vaccine-naïve children induced robust antibody responses.

Keywords

Antibody persistence
Meningococcal B vaccine
Infants
Children
Booster response
2 + 1 schedule
Safety
Open-label randomised clinical trial

Abbreviations

AE
adverse event
CI
confidence interval
FAS
full analysis set
fHbp
factor H-binding protein
GMT
geometric mean titre
hSBA
serum bactericidal activity assay using human complement
IMD
invasive meningococcal disease
MenACWY-CRM
quadrivalent serogroups A, C, W and Y conjugated to the diphtheria toxin mutant CRM197
MenB
meningococcal serogroup B
4CMenB
meningococcal serogroup B vaccine
NadA
Neisserial adhesin A
NHBA
neisserial heparin-binding antigen
PorA
porin A protein
rLP2086
multicomponent vaccine against serogroup B
SAE
serious adverse event
UK
United Kingdom

Cited by (0)

Clinical Trial Registration: NCT01894919.