1. Development and validation of a standardized human complement serum bactericidal activity assay to measure functional antibody responses to Neisseria gonorrhoeae.
- Author
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Matthias KA, Reveille A, Dhara K, Lyle CS, Natuk RJ, Bonk B, and Bash MC
- Abstract
The recent entry of multiple vaccines targeting Neisseria gonorrhoeae (Ng) into the clinical development pathway has highlighted the need to establish methods of adequately assessing anti-gonococcal immune responses. Serum bactericidal activity (SBA) is utilized as a measurement of efficacy in licensure of meningococcal vaccines, but the importance of functional antibodies in preventing and/or clearing gonococcal infections remains largely unknown. In an effort to elucidate the utility of SBA as an immune correlate of protection, we sought to develop a standardized high-throughput human complement SBA (hSBA) assay for which any strain of interest could be tested under uniform conditions, with minimal screening of complement required. Utilization of IgG/IgM-depleted pooled human complement serum permitted testing of diverse serum resistant and sensitive gonococcal and unencapsulated meningococcal strains when bacteria were cultured to induce lipooligosaccharide sialylation; only one of nine randomly selected lots demonstrated intrinsic toxicity. The hSBA assay was well suited for use with multiple test serum sources, including rabbit, mouse, and human serum samples, suggesting widespread applicability., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Brian Bonk, Chris Lyle and Bob Natuk report a relationship with Pel-Freez Biologicals that includes employment. Brian Bonk reports a relationship with Pel-Freez Biologicals that includes board membership, equity and stock. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Published by Elsevier Ltd.)
- Published
- 2024
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