Federico Martinón-Torres1, Alfonso Carmona Martinez2, Róbert Simkó3, Pilar Infante Marquez4, Josep-Lluis Arimany5, Francisco Gimenez-Sanchez6, José Antonio Couceiro Gianzo7, Éva Kovács8, Pablo Rojo9, Huajun Wang10, Chiranjiwi Bhusal11, Daniela Toneatto11. 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 orlicensed 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.
RCT Entities:
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.
Authors: Federico Martinón-Torres; Adolfo García-Sastre; Andrew J Pollard; Carlos Martín; Albert Osterhaus; Shamez N Ladhani; Octavio Ramilo; Jose Gómez Rial; Antonio Salas; F Xavier Bosch; María Martinón-Torres; Michael J Mina; James Cherry Journal: Hum Vaccin Immunother Date: 2021-11-11 Impact factor: 3.452
Authors: Irene Rivero-Calle; Peter Francis Raguindin; Jose Gómez-Rial; Carmen Rodriguez-Tenreiro; Federico Martinón-Torres Journal: Infect Drug Resist Date: 2019-10-09 Impact factor: 4.003