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Vaccine. 2017 Jan 11;35(3):427-434. doi: 10.1016/j.vaccine.2016.11.071. Epub 2016 Nov 29.

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.

Author information

1
Academic Unit of Clinical Experimental Sciences and NIHR Southampton Respiratory Biomedical Research Unit, Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK. Electronic address: R.C.Read@soton.ac.uk.
2
GSK, Philadelphia, USA.
3
Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester, UK.
4
Sheffield University Hospitals Foundation Trust, Sheffield, UK.
5
GSK, Marburg, Germany.
6
GSK, Rotterdam, The Netherlands.
7
GSK, Siena, Italy.

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.

KEYWORDS:

Carriage; Immunogenicity; Meningococcal; Serogroup B; Vaccine

PMID:
27912986
DOI:
10.1016/j.vaccine.2016.11.071
[Indexed for MEDLINE]
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