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Comparison and Correlation of Neisseria meningitidis Serogroup B Immunologic Assay Results and Human Antibody Responses following Three Doses of the Norwegian Meningococcal Outer Membrane Vesicle Vaccine MenBvac

Vaccine Evaluation Unit, Health Protection Agency North West, Manchester Laboratory, Manchester Medical Microbiology Partnership, P.O. Box 209, Clinical Sciences Building II, Manchester Royal Infirmary, Manchester M13 9WZ, United Kingdom,¹ Health Protection Agency, Centre for Emergency Preparedness and Response, Salisbury SP4 OJG, United Kingdom,² Division of Infectious Disease Control, Norwegian Institute of Public Health, NO-0403 Oslo, Norway,³ Department of Cellular and Molecular Medicine, School of Medical Sciences, University of Bristol, University Walk, Bristol BS8 1TD, and Bristol HPA Laboratory, Bristol BS2 8HW, United Kingdom,⁴ Health Protection Agency, Centre for Infections, Colindale, London NW9 5EQ, United Kingdom,⁵ Meningococcal Reference Unit, Health Protection Agency North West, Manchester Laboratory, Manchester Medical Microbiology Partnership, P.O. Box 209, Clinical Sciences Building II, Manchester Royal Infirmary, Manchester M13 9WZ, United Kingdom,⁶ Chiron Vaccines, Via Fiorentina 1, 53100 Siena, Italy⁷

Received 22 March 2006/ Returned for modification 18 April 2006/ Accepted 11 May 2006

The prediction of efficacy of Neisseria meningitidis serogroup B (MenB) vaccines is currently hindered due to the lack of an appropriate correlate of protection. For outer membrane vesicle (OMV) vaccines, immunogenicity has primarily been determined by the serum bactericidal antibody (SBA) assay and OMV enzyme-linked immunosorbent assay (ELISA). However, the opsonophagocytic assay (OPA), surface labeling assay, whole blood assay (WBA), and salivary antibody ELISA have been developed although correlation with protection is presently undetermined. Therefore, the aim of the study was to investigate further the usefulness of, and relationships between, MenB immunologic assays. A phase II trial of the OMV vaccine, MenBvac, with proven efficacy was initiated to compare immunologic assays incorporating the vaccine and six heterologous strains. Correlations were achieved between the SBA assay, OMV ELISA, and OPA using human polymorphonuclear leukocytes and human complement but not between an OPA using HL60 phagocytic cells and baby rabbit complement. Correlations between the surface labeling assay, the SBA assay, and the OMV ELISA were promising, although target strain dependent. Correlations between the salivary antibody ELISA and other assays were poor. Correlations to the WBA were prevented since many samples had results greater than the range of the assay. The study confirmed the immunogenicity and benefit of a third dose of MenBvac against the homologous vaccine strain using a variety of immunologic assays. These results emphasize the need for standardized methodologies that would allow a more robust comparison of assays between laboratories and promote their further evaluation as correlates of protection against MenB disease.

Editor: D. L. Burns

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