Neisseria meningitidis group B correlates of protection and assay standardization-International Meeting Report Emory University, Atlanta, Georgia, United States, 16-17 March 2005

摘要

Background on group B vaccines. Capsular polysaccharide based vaccines. Outer membrane protein vaccines. Correlates of protection, Serum bactericidal antibody versus efficacy, Antibody, avidity, memory and animal models, Opsonophagocytic assays, Sampling and strain selection approaches. Lessons learned from group B clinical trials, Chile trial, Norwegian trials, New Zealand trial, Group C conjugate vaccines and applicability to group B, Statistical approaches to vaccine evaluation. Standardization and harmonization of assays. Serum bactericidal antibody assay, Opsonophagocytic assay. A view from the manufacturers, Netherlands Vaccine Institute, GlaxoSmithKline, Chiron, Wyeth, Sanofi Pasteur, Merck & Co.. A view from the regulatory authorities, US FDA, UK National Institute for Biological Standards and Control. A view from the World Health Organization. Discussion and action items.