Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine

Terry Nolan, Maria Elena Santolaya, Ferdinandus de Looze, Helen Marshall, Peter Richmond, Sam Henein, Paul Rheault, Ken Heaton, Kirsten P. Perrett, Hartley Garfield, Anil Gupta, Murdo Ferguson, Diego D'Agostino, Daniela Toneatto, Miguel O'Ryan

Research output: Contribution to journalArticle

3 Citations (Scopus)

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-naive 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-naive participants of similar age (Naive_4y and Naive_7.5y groups). Primed participants received a booster dose; vaccine-naive 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-naive), 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-naive participants at baseline (= 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-naive participants. A more robust immune response after booster compared to a first dose in vaccine-naive individuals, showed effective priming in an adolescent/young adult population. No safety or new reactogenicity issues were identified. (C) 2019 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd.

Original languageEnglish
Pages (from-to)1209-1218
Number of pages10
JournalVaccine
Volume37
Issue number9
DOIs
Publication statusPublished - 21 Feb 2019

Cite this

Nolan, Terry ; Elena Santolaya, Maria ; de Looze, Ferdinandus ; Marshall, Helen ; Richmond, Peter ; Henein, Sam ; Rheault, Paul ; Heaton, Ken ; Perrett, Kirsten P. ; Garfield, Hartley ; Gupta, Anil ; Ferguson, Murdo ; D'Agostino, Diego ; Toneatto, Daniela ; O'Ryan, Miguel. / Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine. In: Vaccine. 2019 ; Vol. 37, No. 9. pp. 1209-1218.
@article{1fa0489056034990b970f4b4d5f8ffbe,
title = "Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine",
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-naive 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-naive participants of similar age (Naive_4y and Naive_7.5y groups). Primed participants received a booster dose; vaccine-naive 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-naive), 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-naive participants at baseline (= 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-naive participants. A more robust immune response after booster compared to a first dose in vaccine-naive individuals, showed effective priming in an adolescent/young adult population. No safety or new reactogenicity issues were identified. (C) 2019 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd.",
keywords = "4-component serogroup B meningococcal vaccine, Adolescents, Persistence, Immunogenicity, Kinetics, MENINGOCOCCAL ACWY GLYCOCONJUGATE, OBSERVER-BLIND, BACTERICIDAL ANTIBODY, B VACCINE, PHASE-III, DISEASE, EPIDEMIOLOGY, INFANTS, IMPACT, IMMUNOGENICITY",
author = "Terry Nolan and {Elena Santolaya}, Maria and {de Looze}, Ferdinandus and Helen Marshall and Peter Richmond and Sam Henein and Paul Rheault and Ken Heaton and Perrett, {Kirsten P.} and Hartley Garfield and Anil Gupta and Murdo Ferguson and Diego D'Agostino and Daniela Toneatto and Miguel O'Ryan",
year = "2019",
month = "2",
day = "21",
doi = "10.1016/j.vaccine.2018.12.059",
language = "English",
volume = "37",
pages = "1209--1218",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier",
number = "9",

}

Nolan, T, Elena Santolaya, M, de Looze, F, Marshall, H, Richmond, P, Henein, S, Rheault, P, Heaton, K, Perrett, KP, Garfield, H, Gupta, A, Ferguson, M, D'Agostino, D, Toneatto, D & O'Ryan, M 2019, 'Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine' Vaccine, vol. 37, no. 9, pp. 1209-1218. https://doi.org/10.1016/j.vaccine.2018.12.059

Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine. / Nolan, Terry; Elena Santolaya, Maria; de Looze, Ferdinandus; Marshall, Helen; Richmond, Peter; Henein, Sam; Rheault, Paul; Heaton, Ken; Perrett, Kirsten P.; Garfield, Hartley; Gupta, Anil; Ferguson, Murdo; D'Agostino, Diego; Toneatto, Daniela; O'Ryan, Miguel.

In: Vaccine, Vol. 37, No. 9, 21.02.2019, p. 1209-1218.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine

AU - Nolan, Terry

AU - Elena Santolaya, Maria

AU - de Looze, Ferdinandus

AU - Marshall, Helen

AU - Richmond, Peter

AU - Henein, Sam

AU - Rheault, Paul

AU - Heaton, Ken

AU - Perrett, Kirsten P.

AU - Garfield, Hartley

AU - Gupta, Anil

AU - Ferguson, Murdo

AU - D'Agostino, Diego

AU - Toneatto, Daniela

AU - O'Ryan, Miguel

PY - 2019/2/21

Y1 - 2019/2/21

N2 - 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-naive 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-naive participants of similar age (Naive_4y and Naive_7.5y groups). Primed participants received a booster dose; vaccine-naive 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-naive), 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-naive participants at baseline (= 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-naive participants. A more robust immune response after booster compared to a first dose in vaccine-naive individuals, showed effective priming in an adolescent/young adult population. No safety or new reactogenicity issues were identified. (C) 2019 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd.

AB - 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-naive 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-naive participants of similar age (Naive_4y and Naive_7.5y groups). Primed participants received a booster dose; vaccine-naive 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-naive), 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-naive participants at baseline (= 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-naive participants. A more robust immune response after booster compared to a first dose in vaccine-naive individuals, showed effective priming in an adolescent/young adult population. No safety or new reactogenicity issues were identified. (C) 2019 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd.

KW - 4-component serogroup B meningococcal vaccine

KW - Adolescents

KW - Persistence

KW - Immunogenicity

KW - Kinetics

KW - MENINGOCOCCAL ACWY GLYCOCONJUGATE

KW - OBSERVER-BLIND

KW - BACTERICIDAL ANTIBODY

KW - B VACCINE

KW - PHASE-III

KW - DISEASE

KW - EPIDEMIOLOGY

KW - INFANTS

KW - IMPACT

KW - IMMUNOGENICITY

U2 - 10.1016/j.vaccine.2018.12.059

DO - 10.1016/j.vaccine.2018.12.059

M3 - Article

VL - 37

SP - 1209

EP - 1218

JO - Vaccine

JF - Vaccine

SN - 0264-410X

IS - 9

ER -