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J Infect. 2018 Mar;76(3):258-269. doi: 10.1016/j.jinf.2017.12.005. Epub 2017 Dec 15.

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

Author information

1
Translational Paediatrics and Infectious Diseases, Department of Paediatrics, Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela, Spain; Genetics, Vaccines and Infections Research group (GENVIP), Instituto de Investigación Sanitaria de Santiago, Santiago de Compostela, Spain. Electronic address: federico.martinon.torres@sergas.es.
2
Instituto Hispalense de Pediatria de Sevilla, Sevilla, Spain.
3
Primary Care Paediatric Praxis, District 8, Miskolc, Hungary.
4
Hospital Virgen del Mar, Almeria, Spain.
5
Hospital Universitari General de Catalunya, Barcelona, Spain.
6
Torrecárdenas Hospital, The Pediatric Infectiology Unit, Almería, Spain.
7
Complejo Hospitalario de Pontevedra, Hospital Provincial de Pontevedra, Pontevedra, Spain.
8
Praxis Dr Éva Kovács, Szeged, Hungary.
9
Hospital 12 de Octubre, Department of Paediatrics, Paediatric Infectious Diseases Unit, Madrid, Spain; Faculty of Medicine, Complutense University of Madrid, Spain.
10
GSK, Amsterdam, The Netherlands.
11
GSK, Siena, Italy.

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:

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

PMID:
29253560
DOI:
10.1016/j.jinf.2017.12.005
[Indexed for MEDLINE]
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