TY - JOUR TI - Endogenous complement human serum bactericidal assay (enc-hSBA) for vaccine effectiveness assessments against meningococcal serogroup B AU - Kleinschmidt, Annett AU - Vadivelu, Kumaran AU - Serino, Laura AU - Neidig, Nina AU - de Wergifosse, Bertrand T2 - npj Vaccines AB - Immunogenicity of vaccines against meningococcal serogroup B (MenB) has been assessed pre-licensure with a human serum bactericidal activity assay (hSBA), tested against small numbers of strains. We report the qualification/validation of an alternative qualitative hSBA which uses endogenous complement (enc-hSBA) present in the vaccinee’s serum. Serum samples were collected from adults pre-vaccination and post-vaccination with the 4-component MenB vaccine (4CMenB). A representative panel of invasive isolates and 4 antigen-specific indicator strains were used in qualification experiments. Each strain was tested in ≥3 experiments with pre/post-vaccination sera to evaluate intermediate precision. A 110-strain panel and the 4 indicator strains met qualification criteria, demonstrating assay precision. Assay robustness, specificity and sensitivity were demonstrated using the 4 indicator strains. Enc-hSBA is highly standardized, allows testing across large panels of epidemiologically-relevant MenB strains, and accounts for complement activity differences between vaccinees. Therefore, enc-hSBA enables a more accurate estimation of effectiveness for vaccines against MenB. DA - 2021/02/23/ PY - 2021 DO - 10.1038/s41541-021-00286-8 DP - www.nature.com VL - 6 IS - 1 SP - 1 EP - 8 LA - en SN - 2059-0105 UR - https://www.nature.com/articles/s41541-021-00286-8 Y2 - 2021/02/24/03:44:23 ER -