RT Journal Article
T1 Antibody persistence and booster responses 24-36 months after different 4CMenB vaccination schedules in infants and children: A randomised trial.
A1 Martinón-Torres, Federico
A1 Carmona Martinez, Alfonso
A1 Simkó, Róbert
A1 Infante Marquez, Pilar
A1 Arimany, Josep-Lluis
A1 Gimenez-Sanchez, Francisco
A1 Couceiro Gianzo, José Antonio
A1 Kovács, Éva
A1 Rojo, Pablo
A1 Wang, Huajun
A1 Bhusal, Chiranjiwi
A1 Toneatto, Daniela
K1 2 + 1 schedule
K1 Antibody persistence
K1 Booster response
K1 Children
K1 Infants
K1 Meningococcal B vaccine
K1 Open-label randomised clinical trial
K1 Safety
AB 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.
YR 2017
FD 2017-12-15
LK http://hdl.handle.net/10668/11922
UL http://hdl.handle.net/10668/11922
LA en
DS RISalud
RD Apr 7, 2025