Issues surrounding standardization of meningococcal group W135 serology.

Group W135 polysaccharide vaccines were licensed without efficacy trials using the serum bactericidal antibody (SBA) assay as a surrogate of protection. Standardization of group A and C SBA assays has been largely achieved. However, no such efforts have been focussed on W135. Although W135 strains have been recommended by WHO for polysaccharide production, no such recommendation are in place for use in immunoassays. Strain characterization is of importance as W135 strains may possess either an O-acetylated or de-O-acetylated polysaccharide capsule and the human immune response can vary according to the O-acetylation of the target antigen. Following conjugate or polysaccharide vaccination, few data are published with respect to complement source comparisons although both human and baby rabbit sera have been utilized with similar end points. In studies of natural immunity subcapsular antigens are primarily the target antigens and thus strain choice for use in the SBA assay is important. International standardization of assays is necessary to allow for comparisons of data over time and place.