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Title: Antibody persistence and booster responses 24-36 months after different 4CMenB vaccination schedules in infants and children: A randomised trial.
Authors: Martinón-Torres, Federico
Carmona Martinez, Alfonso
Simkó, Róbert
Infante Marquez, Pilar
Arimany, Josep-Lluis
Gimenez-Sanchez, Francisco
Couceiro Gianzo, José Antonio
Kovács, Éva
Rojo, Pablo
Wang, Huajun
Bhusal, Chiranjiwi
Toneatto, Daniela
Keywords: 2 + 1 schedule;Antibody persistence;Booster response;Children;Infants;Meningococcal B vaccine;Open-label randomised clinical trial;Safety
metadata.dc.subject.mesh: Antibodies, Bacterial
Child, Preschool
Immunization Schedule
Immunization, Secondary
Immunogenicity, Vaccine
Meningococcal Vaccines
Neisseria meningitidis, Serogroup B
Time Factors
Issue Date: 15-Dec-2017
Abstract: 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. 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. 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. 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.
metadata.dc.identifier.doi: 10.1016/j.jinf.2017.12.005
Appears in Collections:Producción 2020

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