Public delivery of the pneumoCarr output case for carriage (C4C) and its key components
27-28 March 2012, Geneva, Switzerland
Pneumococcus is a major cause of worldwide mortality and morbidity that is vaccine-preventable. New pneumococcal conjugate vaccines are expected to be licensed in the coming years, and protein-based and non-capsular vaccines are under clinical testing. Carriage of pneumococcus precedes disease and is the reservoir for spread between people. Understanding the impact of vaccine on carriage would advance decision-making for both new and existing pneumococcal vaccines.
The target of the PneumoCarr* project is to establish reduction of nasopharyngeal colonization with pneumococci as part of the licensure process of new pneumococcal vaccines. Based on statistical models of pneumococcal colonization, PneumoCarr aims to develop new guidelines for using “the vaccine efficacy against colonization” (VEcol) as an alternative or additional endpoint in vaccine trials. WHO recommended in 2007 that all countries should introduce pneumococcal conjugate vaccines into the routine immunization programmes.
The work of the PneumoCarr will facilitate public health decision-making by developing the recommendations for determination of the impact of pneumococcal conjugate vaccines in population. The use of vaccine effect on reduction of nasopharyngeal (NP) carriage as part of the vaccine licensure pathway would facilitate and expand the licensure of new pneumococcal vaccines and enable the estimation of population effects after vaccine introduction. By combining statistical modeling, immunological studies and global epidemiological data, the PneumoCarr project has developed methods and guidelines for estimation of vaccine effect on carriage.
A final outcome and deliverable of the PneumoCarr work is the Case for Carriage (C4C) document, a concise summary of all the evidence gathered by the PneumoCarr consortium to support consideration of vaccine efficacy against carriage as part of the pneumococcal vaccine licensure pathway.
Objectives of the meeting
The planned co-sponsored meeting is a technical consultation reviewing the outcomes from the "pneumocarr" project for their relevance to inform future development and formulation of alternative strategies for clinical evaluation and licensure of pneumococcal vaccines. Specific objectives include:
- To share the C4C and the supporting scientific work/principles with external audiences especially WHO, regulators and manufacturers.
- To receive feedback from participants on the C4C and what aspects of it are accepted and what aspects of it remain in question.
- To reach a consensus on the role for NP carriage studies in licensure pathways.
- To generate a list of new work that must be undertaken to further incorporate NP carriage evidence in a licensure pathway.
WHO expected from the meeting:
- to be informed on latest developments on the use "carriage" as a measure of pneumococcal vaccine performance;
- to obtain information on methodological approaches; and
- to get insight into the relevance of the approach for the evaluation of "second-generation" pneumococcal vaccine
On that basis, WHO will decide whether to further evaluate and ultimately develop a regulatory strategy based on carriage.
* The PneumoCarr project is funded by the Grand Challenges in Global Health grant program (the Bill & Melinda Gates Foundation). The project was launched in the beginning of 2006 and will last until the end of 2011.The PneumoCarr consortium consists of nine research institutes from different parts of the world. Each of the nine institutes performs at the highest level of scientific quality and has provided data sets that complement each other in terms of study targets and designs. The consortium is coordinated by the National Institute for Health and Welfare (THL), Finland (Project director: Helena Käyhty, Prof, PhD; Project coordinator: Birgit Simell, PhD). The majority of statistical modelling as well as project management is conducted by the National Institute for Health and Welfare (THL), Finland.