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A phase III observer-blind randomized, controlled study to evaluate the immune response and the correlation with nasopharyngeal carriage after immunization of university students with a quadrivalent meningococcal ACWY glycoconjugate or serogroup B meningococcal vaccine

A phase III observer-blind randomized, controlled study to evaluate the immune response and the correlation with nasopharyngeal carriage after immunization of university students with a quadrivalent meningococcal ACWY glycoconjugate or serogroup B meningococcal vaccine
A phase III observer-blind randomized, controlled study to evaluate the immune response and the correlation with nasopharyngeal carriage after immunization of university students with a quadrivalent meningococcal ACWY glycoconjugate or serogroup B meningococcal vaccine

BACKGROUND: University students have high rates of pharyngeal carriage of Neisseria meningitidis. Interruption of carriage acquisition is an important mechanism of vaccines for inducing herd protection. 4CMenB and MenACWY-CRM vaccines have been shown to be immunogenic against meningococcal serogroups B and ACWY respectively in younger age groups, and also to elicit a modest impact on meningococcal carriage in vaccinated students. However, vaccine responses in university students and the impact of serum bactericidal antibody (SBA) titers on meningococcal carriage are undetermined.

METHODS: Immunogenicity of two 4CMenB doses or one MenACWY-CRM dose was measured in university students at Months 2, 4, 6 and 12 post-first vaccination. Immunogenicity of one MenACWY-CRM dose in students with previous meningococcal serogroup C conjugate vaccination was also assessed. Immune responses were measured with an SBA assay using human complement (hSBA) against three reference strains for serogroup B and against one strain for each for serogroups C and Y. Correlations between hSBA titers and meningococcal carriage were analyzed.

RESULTS: All subjects demonstrated robust functional antibody responses to both vaccines at Month 2 and a high proportion maintained protective hSBA titers up to Month 12. At baseline, carriage of disease-associated serogroup B strains and serogroups C and Y were higher in subjects with already-protective hSBA titers. Post-vaccination, while both 4CMenB and MenACWY-CRM elicited robust immunogenicity in students, significant correlations between post-vaccination hSBA titers and carriage of disease-associated serogroups were not observed.

CONCLUSIONS: 4CMenB and MenACWY-CRM were both highly immunogenic. There was no correlation between carriage and post-vaccination hSBA titers.

Journal Article
427-434
Read, Robert C.
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Dull, Peter
696fc5c3-5bda-49ff-b8d6-e875ef0114be
Bai, Xilian
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Nolan, Kate
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Findlow, Jamie
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Bazaz, Rohit
272d9668-631d-4f35-9bf7-88008c3b5451
Kleinschmidt, Annett
d97a758e-8f40-4bf6-8329-16318e695fcd
McCarthy, Maggie
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Wang, Huajun
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Toneatto, Daniela
bf55b80e-bf0e-40ff-96b7-2bc9aacbdda9
Borrow, Ray
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Read, Robert C.
b5caca7b-0063-438a-b703-7ecbb6fc2b51
Dull, Peter
696fc5c3-5bda-49ff-b8d6-e875ef0114be
Bai, Xilian
9c22a22d-1bfa-4efc-8299-4487dada39b1
Nolan, Kate
d26676c1-4d33-489f-87fb-f319d30518c3
Findlow, Jamie
8580c790-262c-4fc5-99bc-0beddaef98a0
Bazaz, Rohit
272d9668-631d-4f35-9bf7-88008c3b5451
Kleinschmidt, Annett
d97a758e-8f40-4bf6-8329-16318e695fcd
McCarthy, Maggie
5aa2b63a-130b-4c23-9fec-d372864a0c0c
Wang, Huajun
abb5a240-9c74-45da-938a-92f24d8c28fe
Toneatto, Daniela
bf55b80e-bf0e-40ff-96b7-2bc9aacbdda9
Borrow, Ray
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Read, Robert C., Dull, Peter, Bai, Xilian, Nolan, Kate, Findlow, Jamie, Bazaz, Rohit, Kleinschmidt, Annett, McCarthy, Maggie, Wang, Huajun, Toneatto, Daniela and Borrow, Ray (2017) A phase III observer-blind randomized, controlled study to evaluate the immune response and the correlation with nasopharyngeal carriage after immunization of university students with a quadrivalent meningococcal ACWY glycoconjugate or serogroup B meningococcal vaccine. Vaccine, 35 (3), 427-434. (doi:10.1016/j.vaccine.2016.11.071).

Record type: Article

Abstract

BACKGROUND: University students have high rates of pharyngeal carriage of Neisseria meningitidis. Interruption of carriage acquisition is an important mechanism of vaccines for inducing herd protection. 4CMenB and MenACWY-CRM vaccines have been shown to be immunogenic against meningococcal serogroups B and ACWY respectively in younger age groups, and also to elicit a modest impact on meningococcal carriage in vaccinated students. However, vaccine responses in university students and the impact of serum bactericidal antibody (SBA) titers on meningococcal carriage are undetermined.

METHODS: Immunogenicity of two 4CMenB doses or one MenACWY-CRM dose was measured in university students at Months 2, 4, 6 and 12 post-first vaccination. Immunogenicity of one MenACWY-CRM dose in students with previous meningococcal serogroup C conjugate vaccination was also assessed. Immune responses were measured with an SBA assay using human complement (hSBA) against three reference strains for serogroup B and against one strain for each for serogroups C and Y. Correlations between hSBA titers and meningococcal carriage were analyzed.

RESULTS: All subjects demonstrated robust functional antibody responses to both vaccines at Month 2 and a high proportion maintained protective hSBA titers up to Month 12. At baseline, carriage of disease-associated serogroup B strains and serogroups C and Y were higher in subjects with already-protective hSBA titers. Post-vaccination, while both 4CMenB and MenACWY-CRM elicited robust immunogenicity in students, significant correlations between post-vaccination hSBA titers and carriage of disease-associated serogroups were not observed.

CONCLUSIONS: 4CMenB and MenACWY-CRM were both highly immunogenic. There was no correlation between carriage and post-vaccination hSBA titers.

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More information

Accepted/In Press date: 22 November 2016
e-pub ahead of print date: 29 November 2016
Published date: 11 January 2017
Additional Information: Copyright © 2016. Published by Elsevier Ltd.
Keywords: Journal Article

Identifiers

Local EPrints ID: 416149
URI: https://eprints.soton.ac.uk/id/eprint/416149
PURE UUID: dc6dfee7-6aa3-494c-b411-e56d1fc4f7d2
ORCID for Robert C. Read: ORCID iD orcid.org/0000-0002-4297-6728

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Date deposited: 06 Dec 2017 17:30
Last modified: 10 Dec 2019 01:37

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