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dc.contributor.authorvan Ravenhorst, Mariëtte B
dc.contributor.authorvan der Klis, Fiona R M
dc.contributor.authorvan Rooijen, Debbie M
dc.contributor.authorSanders, Elisabeth A M
dc.contributor.authorBerbers, Guy A M
dc.date.accessioned2019-02-18T09:29:28Z
dc.date.available2019-02-18T09:29:28Z
dc.date.issued2019-01-05
dc.identifier.issn1471-2288
dc.identifier.pmid30611213
dc.identifier.doi10.1186/s12874-018-0650-3
dc.identifier.urihttp://hdl.handle.net/10029/622757
dc.description.abstractMucosal antibodies against capsular polysaccharides offer protection against acquisition and carriage of encapsulated bacteria like Neisseria meningitidis serogroup C. Measurements of salivary antibodies as replacement for blood testing has important (cost-effective) advantages, particular in studies that assess the impact of large-scale vaccination or in populations in which blood sampling is difficult. This study aimed to estimate a threshold for meningococcal IgG salivary antibody levels to discriminate between unprotected and protected vaccinated individuals. MenA-, MenC-, MenW- and MenY-polysaccharide (PS) specific IgG levels in serum and saliva from participants in a meningococcal vaccination study were measured using the fluorescent-bead-based multiplex immunoassay. Functional antibody titers in serum against the four serogroups were measured with serum bactericidal assay using rabbit complement (rSBA). A threshold for salivary IgG was determined by analysis of ROC curves using a serum rSBA titer ≥128 as correlate of protection. The area under the curve (AUC) was calculated to quantify the accuracy of the salivary test and was considered adequate when ≥0.80. The optimal cut-off was considered adequate when salivary IgG cut-off levels provided specificity of ≥90%. True positive rate (sensitivity), positive predictive value, and negative predictive value were calculated to explore the possible use of salivary antibody levels as a surrogate of protection. The best ROC curve (AUC of 0.95) was obtained for MenC, with an estimated minimum threshold of MenC-PS specific salivary IgG ≥3.54 ng/mL as surrogate of protection. An adequate AUC (> 0.80) was also observed for MenW and MenY with an estimated minimal threshold of 2.00 and 1.82 ng/mL, respectively. When applying these thresholds, all (100%) samples collected 1 month and 1 year after the (booster) meningococcal vaccination, that were defined as protective in the saliva test for MenC, MenW and MenY, corresponded with concomitant serum rSBA titer ≥128 for the respective meningococcal serogroups. The saliva test offers an alternative screening tool to monitor protective vaccine responses up to one year after meningococcal vaccination against MenC, MenW and MenY. Future (large) longitudinal vaccination studies evaluating also clinical protection against IMD or carriage acquisition are required to validate the currently proposed threshold in saliva.en_US
dc.language.isoenen_US
dc.subjectConjugate meningococcal vaccineen_US
dc.subjectCorrelate of protectionen_US
dc.subjectNeisseria meningitidisen_US
dc.subjectSalivary surrogate of protectionen_US
dc.subjectThresholden_US
dc.titleUse of saliva to monitor meningococcal vaccine responses: proposing a threshold in saliva as surrogate of protection.en_US
dc.typeArticleen_US
dc.identifier.journalBMC Med Res Methodol 2019; 19(1):1en_US
dc.source.journaltitleBMC medical research methodology


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