Terry Nolan1, Maria Elena Santolaya2, Ferdinandus de Looze3, Helen Marshall4, Peter Richmond5, Sam Henein6, Paul Rheault7, Ken Heaton7, Kirsten P Perrett8, Hartley Garfield9, Anil Gupta9, Murdo Ferguson10, Diego D'Agostino11, Daniela Toneatto12, Miguel O'Ryan13. 1. Vaccine and Immunisation Research Group (VIRGo) at the University of Melbourne School of Population and Global Health and Murdoch Children's Research Institute, Melbourne, Victoria, Australia. 2. Department of Pediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile. 3. School of Medicine, University of Queensland and AusTrials Pty Ltd, Brisbane, Australia. 4. Adelaide Medical School and Robinson Research Institute, The University of Adelaide and Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, South Australia, Australia. 5. Division of Paediatrics and Centre for Child Health Research, University of Western Australia, Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Princess Margaret Hospital for Children, Perth, Australia. 6. University of Toronto, Toronto, Ontario, Canada. 7. Medicor Research Inc, Sudbury, Ontario, Canada. 8. Murdoch Children's Research Institute and Melbourne School of Population and Global Health, University of Melbourne and Royal Children's Hospital, Melbourne, VIC, Australia. 9. University of Toronto, Department of Medicine, Queen's University and The Hospital for Sick Children, Toronto, Ontario, Canada. 10. Colchester Research Group, Truro, Nova Scotia, Canada. 11. GSK, Amsterdam, the Netherlands. 12. GSK, Siena, Italy. 13. Microbiology and Mycology Program, Institute of Biomedical Sciences, and Millennium Institute of Immunology and Immunotherapy, Faculty of Medicine, Universidad de Chile, Santiago, Chile. Electronic address: moryan@med.uchile.cl.
Abstract
BACKGROUND: Data on duration of protection against invasive meningococcal disease post-vaccination with the recombinant, 4-component, meningococcal serogroup B vaccine (4CMenB) are limited. We evaluated bactericidal activity persistence in adolescents/young adults up to 7.5 years post-primary vaccination with 4CMenB, and response to a booster dose compared with vaccine-naïve controls. METHODS: This open-label, multicenter study (NCT02446743) enrolled 15-24 year-old-previously vaccinated participants from Canada, Australia (group Primed_4y) 4 years post-priming with 4CMenB (2 doses; 0,1-month schedule), and Chile (Primed_7.5y) 7.5 years after priming with 4CMenB (2 doses; 0,1/0,2/0,6-month schedule) and vaccine-naïve participants of similar age (Naïve_4y and Naïve_7.5y groups). Primed participants received a booster dose; vaccine-naïve participants received 2 catch-up doses of 4CMenB, 1 month apart. We evaluated antibody persistence and immune responses using hSBA in terms of geometric mean titers and percentages of participants with hSBA titers ≥4, the kinetics of bactericidal activity post-booster (previously vaccinated) or post-2 doses (vaccine-naïve), and safety. RESULTS: Antibody levels declined at 4 (Primed_4y) and 7.5 (Primed_7.5y) years post-primary vaccination, but remained higher than in vaccine-naïve participants at baseline (≤44% vs ≤ 13% [fHbp]; ≤84% vs ≤ 24% [NadA]; ≤29% vs ≤ 14% [PorA]) for all vaccine antigens except NHBA (≤81% vs ≤ 79%). One month post-booster and post-second dose, 93-100% of primed and 79-100% of vaccine-naïve participants had hSBA titers ≥4 for all antigens. Kinetics of the antibody response were similar across groups with an early robust response observed 7 days post-booster/second dose. No vaccine-related serious adverse event was reported. CONCLUSION: For all antigens except NHBA, a higher proportion of primed participants had hSBA titers ≥4, at 4 and 7.5 years post-vaccination, compared with vaccine-naïve participants. A more robust immune response after booster compared to a first dose in vaccine-naïve individuals, showed effective priming in an adolescent/young adult population. No safety or new reactogenicity issues were identified.
BACKGROUND: Data on duration of protection against invasive meningococcal disease post-vaccination with the recombinant, 4-component, meningococcal serogroup B vaccine (4CMenB) are limited. We evaluated bactericidal activity persistence in adolescents/young adults up to 7.5 years post-primary vaccination with 4CMenB, and response to a booster dose compared with vaccine-naïve controls. METHODS: This open-label, multicenter study (NCT02446743) enrolled 15-24 year-old-previously vaccinated participants from Canada, Australia (group Primed_4y) 4 years post-priming with 4CMenB (2 doses; 0,1-month schedule), and Chile (Primed_7.5y) 7.5 years after priming with 4CMenB (2 doses; 0,1/0,2/0,6-month schedule) and vaccine-naïve participants of similar age (Naïve_4y and Naïve_7.5y groups). Primed participants received a booster dose; vaccine-naïve participants received 2 catch-up doses of 4CMenB, 1 month apart. We evaluated antibody persistence and immune responses using hSBA in terms of geometric mean titers and percentages of participants with hSBA titers ≥4, the kinetics of bactericidal activity post-booster (previously vaccinated) or post-2 doses (vaccine-naïve), and safety. RESULTS: Antibody levels declined at 4 (Primed_4y) and 7.5 (Primed_7.5y) years post-primary vaccination, but remained higher than in vaccine-naïve participants at baseline (≤44% vs ≤ 13% [fHbp]; ≤84% vs ≤ 24% [NadA]; ≤29% vs ≤ 14% [PorA]) for all vaccine antigens except NHBA (≤81% vs ≤ 79%). One month post-booster and post-second dose, 93-100% of primed and 79-100% of vaccine-naïve participants had hSBA titers ≥4 for all antigens. Kinetics of the antibody response were similar across groups with an early robust response observed 7 days post-booster/second dose. No vaccine-related serious adverse event was reported. CONCLUSION: For all antigens except NHBA, a higher proportion of primed participants had hSBA titers ≥4, at 4 and 7.5 years post-vaccination, compared with vaccine-naïve participants. A more robust immune response after booster compared to a first dose in vaccine-naïve individuals, showed effective priming in an adolescent/young adult population. No safety or new reactogenicity issues were identified.
Authors: Sarah A Mbaeyi; Catherine H Bozio; Jonathan Duffy; Lorry G Rubin; Susan Hariri; David S Stephens; Jessica R MacNeil Journal: MMWR Recomm Rep Date: 2020-09-25
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
Authors: Irene Rivero-Calle; Jose Gómez-Rial; Louis Bont; Bradford D Gessner; Melvin Kohn; Ron Dagan; Daniel C Payne; Laia Bruni; Andrew J Pollard; Adolfo García-Sastre; Denise L Faustman; Albert Osterhaus; Robb Butler; Francisco Giménez Sánchez; Francisco Álvarez; Myrsini Kaforou; Xabier Bello; Federico Martinón-Torres Journal: Hum Vaccin Immunother Date: 2020-08-05 Impact factor: 3.452