Persistence of Bactericidal Antibodies After Infant Serogroup B Meningococcal Immunization and Booster Dose Response at 12, 18 or 24 Months of Age

Matthew D Snape; Merryn Voysey; Adam Finn; Gianni Bona; Susanna Esposito; Nicola Principi; Javier Diez-Domingo; Etienne Sokal; Dorothee Kieninger; Roman Prymula; Peter M Dull; Igor Kohl; Michelangelo Barone; Huajun Wang; Daniela Toneatto; Andrew J Pollard; European MenB Vaccine Study Group

doi:10.1097/INF.0000000000001056

Persistence of Bactericidal Antibodies After Infant Serogroup B Meningococcal Immunization and Booster Dose Response at 12, 18 or 24 Months of Age

Matthew D Snape, Merryn Voysey, Adam Finn, Gianni Bona, Susanna Esposito, Nicola Principi, Javier Diez-Domingo, Etienne Sokal, Dorothee Kieninger, Roman Prymula, Peter M Dull, Igor Kohl, Michelangelo Barone, Huajun Wang, Daniela Toneatto, Andrew J Pollard, European MenB Vaccine Study Group

Research output: Contribution to journal › Article › peer-review

26 Citations (Scopus)

Abstract

BACKGROUND: A serogroup B meningococcal vaccine (4CMenB) is licensed for infant use in countries including Canada, Australia and those of the European Union. Data on serum bactericidal antibody (hSBA) waning and the ideal timing of a "toddler" booster dose are essential to optimize vaccine utilization.

METHODS: An open-labeled, multicenter phase-2b follow-on European study conducted from 2009 to 2012. Participants previously receiving 4CMenB with routine vaccines at 2, 4 and 6 or 2, 3 and 4 months (246Con and 234Con) or at 2, 4 and 6 months intercalated with routine vaccines (246Int) received a booster dose at 12, 18 or 24 months. 4CMenB-naïve "Control" participants aged 12, 18 or 24 months received 2 doses of 4CMenB 2 months apart.

RESULTS: One thousand five hundred eighty-eight participants were recruited. At 12 months, before any booster doses, the proportions with hSBA titers ≥1:5 for strain 44/76-SL (testing vaccine component fHBP) were 73% (120/165) for the "246Con" group, 85% (125/147) for "246Int," 57% (51/90) for "234Con" and 13% (26/199) for Controls. For strain 5/99 (NadA) proportions were ≥96% (all 4CMenB-recipients) and 1% (Controls). For strain NZ98/254 (PorA), these were 18-35% (4CMenB-recipients) and 1% (Controls). By 24 months, 4CMenB-recipient proportions were 13-22% (44/76-SL), 82-94% (5/99) and 7-13% (NZ98/254) and in controls ≤4%. After a 12-month booster-dose, ≥95% of previously immunized participants had titers ≥1:5 (all strains).

CONCLUSIONS: A 4CMenB booster-dose can overcome waning hSBA titers after early-infant immunization. Administration at 12 months could help to maintain immunity during an age of high risk, and the persistence of this response requires further study.

Original language	English
Pages (from-to)	e113-e123
Number of pages	11
Journal	Pediatric Infectious Disease Journal
Volume	35
Issue number	4
DOIs	https://doi.org/10.1097/INF.0000000000001056
Publication status	Published - Apr 2016

Keywords

Meningococcal
Immunization
bactericidal antibodies

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10.1097/INF.0000000000001056

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Snape, M. D., Voysey, M., Finn, A., Bona, G., Esposito, S., Principi, N., Diez-Domingo, J., Sokal, E., Kieninger, D., Prymula, R., Dull, P. M., Kohl, I., Barone, M., Wang, H., Toneatto, D., Pollard, A. J., & European MenB Vaccine Study Group (2016). Persistence of Bactericidal Antibodies After Infant Serogroup B Meningococcal Immunization and Booster Dose Response at 12, 18 or 24 Months of Age. Pediatric Infectious Disease Journal, 35(4), e113-e123. https://doi.org/10.1097/INF.0000000000001056

Snape, Matthew D ; Voysey, Merryn ; Finn, Adam ; Bona, Gianni ; Esposito, Susanna ; Principi, Nicola ; Diez-Domingo, Javier ; Sokal, Etienne ; Kieninger, Dorothee ; Prymula, Roman ; Dull, Peter M ; Kohl, Igor ; Barone, Michelangelo ; Wang, Huajun ; Toneatto, Daniela ; Pollard, Andrew J ; European MenB Vaccine Study Group. / Persistence of Bactericidal Antibodies After Infant Serogroup B Meningococcal Immunization and Booster Dose Response at 12, 18 or 24 Months of Age. In: Pediatric Infectious Disease Journal. 2016 ; Vol. 35, No. 4. pp. e113-e123.

@article{a75b96647c73458186ec35313c7c775a,

title = "Persistence of Bactericidal Antibodies After Infant Serogroup B Meningococcal Immunization and Booster Dose Response at 12, 18 or 24 Months of Age",

abstract = "BACKGROUND: A serogroup B meningococcal vaccine (4CMenB) is licensed for infant use in countries including Canada, Australia and those of the European Union. Data on serum bactericidal antibody (hSBA) waning and the ideal timing of a {"}toddler{"} booster dose are essential to optimize vaccine utilization.METHODS: An open-labeled, multicenter phase-2b follow-on European study conducted from 2009 to 2012. Participants previously receiving 4CMenB with routine vaccines at 2, 4 and 6 or 2, 3 and 4 months (246Con and 234Con) or at 2, 4 and 6 months intercalated with routine vaccines (246Int) received a booster dose at 12, 18 or 24 months. 4CMenB-na{\"i}ve {"}Control{"} participants aged 12, 18 or 24 months received 2 doses of 4CMenB 2 months apart.RESULTS: One thousand five hundred eighty-eight participants were recruited. At 12 months, before any booster doses, the proportions with hSBA titers ≥1:5 for strain 44/76-SL (testing vaccine component fHBP) were 73% (120/165) for the {"}246Con{"} group, 85% (125/147) for {"}246Int,{"} 57% (51/90) for {"}234Con{"} and 13% (26/199) for Controls. For strain 5/99 (NadA) proportions were ≥96% (all 4CMenB-recipients) and 1% (Controls). For strain NZ98/254 (PorA), these were 18-35% (4CMenB-recipients) and 1% (Controls). By 24 months, 4CMenB-recipient proportions were 13-22% (44/76-SL), 82-94% (5/99) and 7-13% (NZ98/254) and in controls ≤4%. After a 12-month booster-dose, ≥95% of previously immunized participants had titers ≥1:5 (all strains).CONCLUSIONS: A 4CMenB booster-dose can overcome waning hSBA titers after early-infant immunization. Administration at 12 months could help to maintain immunity during an age of high risk, and the persistence of this response requires further study.",

keywords = "Meningococcal , Immunization, bactericidal antibodies",

author = "Snape, {Matthew D} and Merryn Voysey and Adam Finn and Gianni Bona and Susanna Esposito and Nicola Principi and Javier Diez-Domingo and Etienne Sokal and Dorothee Kieninger and Roman Prymula and Dull, {Peter M} and Igor Kohl and Michelangelo Barone and Huajun Wang and Daniela Toneatto and Pollard, {Andrew J} and {European MenB Vaccine Study Group} and Anne Malfroot",

year = "2016",

month = apr,

doi = "10.1097/INF.0000000000001056",

language = "English",

volume = "35",

pages = "e113--e123",

journal = "Pediatric Infectious Disease Journal",

issn = "0891-3668",

publisher = "Lippincott Williams and Wilkins",

number = "4",

}

Snape, MD, Voysey, M, Finn, A, Bona, G, Esposito, S, Principi, N, Diez-Domingo, J, Sokal, E, Kieninger, D, Prymula, R, Dull, PM, Kohl, I, Barone, M, Wang, H, Toneatto, D, Pollard, AJ & European MenB Vaccine Study Group 2016, 'Persistence of Bactericidal Antibodies After Infant Serogroup B Meningococcal Immunization and Booster Dose Response at 12, 18 or 24 Months of Age', Pediatric Infectious Disease Journal, vol. 35, no. 4, pp. e113-e123. https://doi.org/10.1097/INF.0000000000001056

Persistence of Bactericidal Antibodies After Infant Serogroup B Meningococcal Immunization and Booster Dose Response at 12, 18 or 24 Months of Age. / Snape, Matthew D; Voysey, Merryn; Finn, Adam; Bona, Gianni; Esposito, Susanna; Principi, Nicola; Diez-Domingo, Javier; Sokal, Etienne; Kieninger, Dorothee; Prymula, Roman; Dull, Peter M; Kohl, Igor; Barone, Michelangelo; Wang, Huajun; Toneatto, Daniela; Pollard, Andrew J; European MenB Vaccine Study Group.

In: Pediatric Infectious Disease Journal, Vol. 35, No. 4, 04.2016, p. e113-e123.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Persistence of Bactericidal Antibodies After Infant Serogroup B Meningococcal Immunization and Booster Dose Response at 12, 18 or 24 Months of Age

AU - Snape, Matthew D

AU - Voysey, Merryn

AU - Finn, Adam

AU - Bona, Gianni

AU - Esposito, Susanna

AU - Principi, Nicola

AU - Diez-Domingo, Javier

AU - Sokal, Etienne

AU - Kieninger, Dorothee

AU - Prymula, Roman

AU - Dull, Peter M

AU - Kohl, Igor

AU - Barone, Michelangelo

AU - Wang, Huajun

AU - Toneatto, Daniela

AU - Pollard, Andrew J

AU - European MenB Vaccine Study Group

AU - Malfroot, Anne

PY - 2016/4

Y1 - 2016/4

N2 - BACKGROUND: A serogroup B meningococcal vaccine (4CMenB) is licensed for infant use in countries including Canada, Australia and those of the European Union. Data on serum bactericidal antibody (hSBA) waning and the ideal timing of a "toddler" booster dose are essential to optimize vaccine utilization.METHODS: An open-labeled, multicenter phase-2b follow-on European study conducted from 2009 to 2012. Participants previously receiving 4CMenB with routine vaccines at 2, 4 and 6 or 2, 3 and 4 months (246Con and 234Con) or at 2, 4 and 6 months intercalated with routine vaccines (246Int) received a booster dose at 12, 18 or 24 months. 4CMenB-naïve "Control" participants aged 12, 18 or 24 months received 2 doses of 4CMenB 2 months apart.RESULTS: One thousand five hundred eighty-eight participants were recruited. At 12 months, before any booster doses, the proportions with hSBA titers ≥1:5 for strain 44/76-SL (testing vaccine component fHBP) were 73% (120/165) for the "246Con" group, 85% (125/147) for "246Int," 57% (51/90) for "234Con" and 13% (26/199) for Controls. For strain 5/99 (NadA) proportions were ≥96% (all 4CMenB-recipients) and 1% (Controls). For strain NZ98/254 (PorA), these were 18-35% (4CMenB-recipients) and 1% (Controls). By 24 months, 4CMenB-recipient proportions were 13-22% (44/76-SL), 82-94% (5/99) and 7-13% (NZ98/254) and in controls ≤4%. After a 12-month booster-dose, ≥95% of previously immunized participants had titers ≥1:5 (all strains).CONCLUSIONS: A 4CMenB booster-dose can overcome waning hSBA titers after early-infant immunization. Administration at 12 months could help to maintain immunity during an age of high risk, and the persistence of this response requires further study.

AB - BACKGROUND: A serogroup B meningococcal vaccine (4CMenB) is licensed for infant use in countries including Canada, Australia and those of the European Union. Data on serum bactericidal antibody (hSBA) waning and the ideal timing of a "toddler" booster dose are essential to optimize vaccine utilization.METHODS: An open-labeled, multicenter phase-2b follow-on European study conducted from 2009 to 2012. Participants previously receiving 4CMenB with routine vaccines at 2, 4 and 6 or 2, 3 and 4 months (246Con and 234Con) or at 2, 4 and 6 months intercalated with routine vaccines (246Int) received a booster dose at 12, 18 or 24 months. 4CMenB-naïve "Control" participants aged 12, 18 or 24 months received 2 doses of 4CMenB 2 months apart.RESULTS: One thousand five hundred eighty-eight participants were recruited. At 12 months, before any booster doses, the proportions with hSBA titers ≥1:5 for strain 44/76-SL (testing vaccine component fHBP) were 73% (120/165) for the "246Con" group, 85% (125/147) for "246Int," 57% (51/90) for "234Con" and 13% (26/199) for Controls. For strain 5/99 (NadA) proportions were ≥96% (all 4CMenB-recipients) and 1% (Controls). For strain NZ98/254 (PorA), these were 18-35% (4CMenB-recipients) and 1% (Controls). By 24 months, 4CMenB-recipient proportions were 13-22% (44/76-SL), 82-94% (5/99) and 7-13% (NZ98/254) and in controls ≤4%. After a 12-month booster-dose, ≥95% of previously immunized participants had titers ≥1:5 (all strains).CONCLUSIONS: A 4CMenB booster-dose can overcome waning hSBA titers after early-infant immunization. Administration at 12 months could help to maintain immunity during an age of high risk, and the persistence of this response requires further study.

KW - Meningococcal

KW - Immunization

KW - bactericidal antibodies

U2 - 10.1097/INF.0000000000001056

DO - 10.1097/INF.0000000000001056

M3 - Article

C2 - 26756390

VL - 35

SP - e113-e123

JO - Pediatric Infectious Disease Journal

JF - Pediatric Infectious Disease Journal

SN - 0891-3668

IS - 4

ER -

Persistence of Bactericidal Antibodies After Infant Serogroup B Meningococcal Immunization and Booster Dose Response at 12, 18 or 24 Months of Age

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