Validation and use of a serum bactericidal antibody assay for Neisseria meningitidis serogroup X in a seroprevalence study in Niger, West Africa

Katz, Sara, Townsend-Payne, Kelly, Louth, Jennifer, Lee-Jones, Lisa ORCID: https://orcid.org/0000-0003-1255-3545, Trotter, Caroline, Dan Dano, Ibrahim and Borrow, Ray (2022) Validation and use of a serum bactericidal antibody assay for Neisseria meningitidis serogroup X in a seroprevalence study in Niger, West Africa. Vaccine, 40 (42). pp. 6042-6047. ISSN 0264-410X

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Abstract

Invasive meningococcal disease (IMD) affects approximately 1.2 million people worldwide annually. Prevention of IMD is mostly provided through vaccination; however, no licensed vaccine is currently available to protect against meningococcal serogroup X associated infection. Limited data are available on the natural immunity to Neisseria meningitidis serogroup X within the African sub-Saharan meningitis belt. The objective of the study was to provide an overview of natural immunity to serogroup X within a community in the African meningitis belt prior to the introduction of a pentavalent conjugate vaccine (NmCV-5). Prior to its introduction, a validated assay to assess vaccine efficacy was also required. This study therefore incorporated two objectives: a seroprevalence study to assess natural immunity in serum samples (n = 377) collected from Niger, West Africa in 2012, and the validation of a serogroup X serum bactericidal antibody (SBA) assay. Seroprevalence data obtained found that natural immunity to N. meningitidis serogroup X were present in 52.3% of study participants. The highest putative protective titres (≥8) to serogroup X were seen in age group 5–14 years-old (73.9%) and lowest in ages < 1 year old (0%). The SBA assay was successfully validated for selectivity/specificity, precision/reproducibility, linearity, and stability. This study demonstrated the suitability of the serogroup X SBA assay in clinical trials for future meningococcal conjugate vaccines containing serogroup X polysaccharides.

Item Type:	Article
Peer-reviewed:	Yes
Date Deposited:	27 Sep 2022 10:28
Publisher:	Elsevier
Additional Information:	This is an Open Access article which appeared in Vaccine, published by Elsevier
Divisions:	Faculties > Science and Engineering
Subject terms:	MenAfriCar Consortium, Humans, Neisseria meningitidis, Meningococcal Infections, Meningococcal Vaccines, Vaccines, Combined, Vaccines, Conjugate, Antibodies, Bacterial, Seroepidemiologic Studies, Reproducibility of Results, Adolescent, Child, Child, Preschool, Infant, Niger, Serum Bactericidal Antibody Assay, Serogroup, Neisseria meningitidis, Niger, Serum bactericidal antibody, serogroup X, Adolescent, Antibodies, Bacterial, Child, Child, Preschool, Humans, Infant, Meningococcal Infections, Meningococcal Vaccines, Neisseria meningitidis, Niger, Reproducibility of Results, Seroepidemiologic Studies, Serogroup, Serum Bactericidal Antibody Assay, Vaccines, Combined, Vaccines, Conjugate, 06 Biological Sciences, 07 Agricultural and Veterinary Sciences, 11 Medical and Health Sciences, Virology
URI:	https://e-space.mmu.ac.uk/id/eprint/630436
DOI:	https://doi.org/10.1016/j.vaccine.2022.08.013
ISSN	0264-410X
e-ISSN	1873-2518

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