An international vaccine meeting on correlates of protection and assay standardization for Neisseria meningitidis group B was held at Emory University, Atlanta, GA, 16–17 March 2005. The purpose of the meeting was to identify laboratory, epidemiological and statistical impediments to the development and licensure of N. meningitidis group B vaccines as viewed by vaccine manufacturers, regulatory authorities, academic and government researchers, and the World Health Organization. Presentations from the meeting are available at http://www. secenterbiothreats. org/Mening. htm. The meeting’s sessions were devoted to the following topics: background on group B vaccines; correlates of protection; lessons learned from group B clinical trials; assay standardization and harmonization; a view from the manufacturers; a view from regulatory authorities; and a view from the World Health Organization.
The goals of the meeting were to discuss and provide epidemiologic, laboratory and statistical guidance on the use and application of correlates of protection used in the development and evaluation of N. meningitidis group B candidate vaccines; to discuss and establish a framework for global harmonization of assays and reagents that will be accepted by regulatory authorities for the licensure of group B meningococcal vaccines; discuss the establishment of a strain, reagent, etc., repository for the maintenance, distribution and archiving of critical materials; and to encourage WHO to take the lead in coordination of these activities and to function as a focal point for subsequent activities. We propose a pathway forward by developing a prioritized list of actionable items. Meningococcal disease continues to be a major global health problem [1]. Rates are highest in the very young but half of cases occur in adolescents and adults. Disease can most effectively be controlled and prevented by vaccination. Group A meningococci cause disease in Africa and Asia as well as large epidemics in sub-Saharan Africa, whilst groups B and C organisms are responsible for sporadic cases, localized outbreaks and epidemics of disease world-wide. Notable