Timo Vesikari1, Roman Prymula2, Elizabeth Merrall3, Igor Kohl3, Daniela Toneatto4, Peter M Dull5. 1. University of Tampere Medical School, Tampere, Finland. 2. University Hospital Hradec Kralove, Hradec Kralove, Czech Republic. 3. Novartis Vaccines and Diagnostics S.r.l., Siena, Italy. 4. Novartis Vaccines and Diagnostics S.r.l., Siena, Italy. Electronic address: daniela.toneatto@novartis.com. 5. Novartis Vaccines and Diagnostics, Cambridge, MA, United States.
Abstract
OBJECTIVE: The multicomponent, recombinant serogroup B vaccine, 4CMenB, is approved in Europe, Canada and Australia from two months of age. We investigated persistence to booster doses at 12 months of age following infant vaccination, and immune response to catch-up vaccination of toddlers and children up to two years of age. METHODS: We assessed persistence of immune responses after one year in participants vaccinated as infants, and responses to two doses at 12-15 or 24-26 months of age in vaccine-naïve children, as serum bactericidal activity with human complement (hSBA) against indicator strains for four vaccine antigens. Adverse events were recorded after each vaccination. RESULTS: High antibody titers were induced against all four 4CMenB components following booster vaccination in infant-primed toddlers and after two doses in previously unvaccinated toddlers or two-year-olds. Antibodies waned over 12 months, particularly those against NZ OMV. Systemic reactogenicity in toddlers was lower than in infants, and lower again in vaccine-naïve two-year-olds. Local reactogenicity was common in all groups. CONCLUSIONS: Four infant or two toddler 4CMenB vaccinations elicit immune responses believed to be protective for the first two years of life, which can be boosted. Reactogenicity is lower in toddlers than in infants.
OBJECTIVE: The multicomponent, recombinant serogroup B vaccine, 4CMenB, is approved in Europe, Canada and Australia from two months of age. We investigated persistence to booster doses at 12 months of age following infant vaccination, and immune response to catch-up vaccination of toddlers and children up to two years of age. METHODS: We assessed persistence of immune responses after one year in participants vaccinated as infants, and responses to two doses at 12-15 or 24-26 months of age in vaccine-naïve children, as serum bactericidal activity with human complement (hSBA) against indicator strains for four vaccine antigens. Adverse events were recorded after each vaccination. RESULTS: High antibody titers were induced against all four 4CMenB components following booster vaccination in infant-primed toddlers and after two doses in previously unvaccinated toddlers or two-year-olds. Antibodies waned over 12 months, particularly those against NZ OMV. Systemic reactogenicity in toddlers was lower than in infants, and lower again in vaccine-naïve two-year-olds. Local reactogenicity was common in all groups. CONCLUSIONS: Four infant or two toddler 4CMenB vaccinations elicit immune responses believed to be protective for the first two years of life, which can be boosted. Reactogenicity is lower in toddlers than in infants.
Authors: Manish Sadarangani; Tim Sell; Mildred A Iro; Matthew D Snape; Merryn Voysey; Adam Finn; Paul T Heath; Gianni Bona; Susanna Esposito; Javier Diez-Domingo; Roman Prymula; Adefowope Odueyungbo; Daniela Toneatto; Andrew J Pollard Journal: CMAJ Date: 2017-10-16 Impact factor: 8.262
Authors: Rodolfo Villena; Marco Aurelio P Safadi; María Teresa Valenzuela; Juan P Torres; Adam Finn; Miguel O'Ryan Journal: Hum Vaccin Immunother Date: 2018-04-30 Impact factor: 3.452
Authors: A R Giuliani; A Mattei; A Appetiti; D Pompei; F Di Donna; F Fiasca; L Fabiani Journal: Hum Vaccin Immunother Date: 2018-06-21 Impact factor: 3.452