An international consultation was convened in Geneva, Switzerland, March 2012 to provide vaccine manufacturers and regulators the opportunity to understand and comment on the “Case for Carriage” (C4C). The meeting objectives were four-fold: (a) to share the C4C and supporting scientific work with external audiences; (b) to receive feedback on the C4C and what aspects contained therein are accepted and what aspects remain in question; (c) to reach a consensus on the role for NP carriage studies in licensure pathways; and (d) to generate a list of new work that must be undertaken to further incorporate Ibrutinib nmr NP carriage evidence in the licensure pathway, if that is seen as a goal.
The consultation was hosted and co-sponsored by the WHO and PneumoCarr. Regulators, manufacturers and developers of pneumococcal vaccines, academic vaccine researchers and representatives CHIR-99021 molecular weight from public health bodies attended the consultation (see
Appendix A for list of participants). Dr. Joachim Hombach, Acting Head, Initiative for Vaccine Research, WHO, opened the meeting by identifying this consultation as an opportunity to share up-to-date information and move toward better tools to describe the public health performance and evaluation of pneumococcal vaccines, namely the consideration of NP carriage as a primary endpoint for licensure. Dr. Helena Käyhty, National Institute for Health and Welfare (THL), Finland, and Project Director, PneumoCarr, introduced the PneumoCarr consortium and its objectives. Dr. Hanna Nohynek (THL, Finland) and Dr. Lieke Sanders (Utrecht University Center, The Netherlands) co-chaired the first day of the meeting, and Dr. Katherine O’Brien (Johns Hopkins Bloomberg School of Public Health, USA) and Prof. David Goldblatt (University College London, UK) co-chaired the second day. Dr. Meena Ramakrishnan served as a rapporteur. To set the stage for the consideration of VE-col as an alternative or surrogate endpoint for vaccine licensure, Dr. Katherine O’Brien reviewed the data supporting
pneumococcal carriage as a necessary precursor for to disease (recently reviewed by Pneumocarr and Ref. , Section II) . Data at the individual, group and population level support the causal link between NP carriage and disease and hence the consideration of NP carriage as a candidate surrogate for pneumococcal disease endpoints. At the individual level, studies following children over time help elucidate the temporal association between NP carriage and disease. Acquisition is the initial event when a pneumococcal strain establishes itself within a host by entry and attachment to the NP mucosa. Afterwards, ongoing presence of the bacteria constitutes NP colonization, or NP carriage. Longitudinal studies have shown that the risk of infection by a pneumococcal strain is highest following its recent acquisition rather than during a prolonged period of carriage.