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

Autor: Katz S; Vaccine Evaluation Unit, UK Health Security Agency, UK., Townsend-Payne K; Vaccine Evaluation Unit, UK Health Security Agency, UK., Louth J; Vaccine Evaluation Unit, UK Health Security Agency, UK., Lee-Jones L; Manchester Metropolitan University, UK., Trotter C; University of Cambridge, UK., Dan Dano I; Centre de Recherche Médicale et Sanitaire, Niamey, Niger., Borrow R; Vaccine Evaluation Unit, UK Health Security Agency, UK.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2022 Oct 06; Vol. 40 (42), pp. 6042-6047. Date of Electronic Publication: 2022 Sep 08.
DOI: 10.1016/j.vaccine.2022.08.013
Abstrakt: 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.
Competing Interests: Declaration of Competing Interest Authors S. Katz, K. Townsend-Payne, J. Louth and R. Borrow perform contract research on behalf of the UK Health Security Agency (UKHSA) for GSK plc, PATH, Pfizer and Sanofi Pasteur.
(Crown Copyright © 2022. Published by Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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