PneumoCarr

Introduction Key messages Goals and outputs Partners Funding Publications Contact information PneuCarriage Project (former Microbiology Project)

Members page

:: Goals and outputs of PneumoCarr

The PneumoCarr goals

Goal 1
To expand the pneumococcal vaccine licensure process by developing the regulatory pathway for the use of vaccine efficacy against pneumococcal colonization (VEcol) as part of the licensure process

To meet this goal, we develop the scientific basis, analytic tools and guidelines for the use of VEcol as an endpoint in vaccine trials, including

  • the methodology to estimate VEcol
  • a trial protocol for VEcol endpoints

Goal 2
To facilitate public health decision-making by developing the recommendations for determination of the impact of pneumococcal conjugate vaccines in population

To meet this goal, we establish the technical community understanding and acceptance for using VEcol for public health purposes. This includes

  • a model to estimate the long-term effects of pneumococcal conjugate vaccination on pneumococcal colonization and invasive disease

In addition, a mutual tool to meet both of the PneumoCarr goals above will be communication via

  • summaries of existing knowledge on pneumococcal colonization, disease and the effects of vaccination (see below: The PneumoCarr outputs).

  • workshops for technical experts for the discussion of pneumococcal colonization as a part of the licensure pathway i) Helsinki Carriage Workshop (HCW); June 2007, Kirkkonummi, Finland ii) Modelling, Computation, and Measurement of Multitype Carriage (MCMMC09); December 2009, Saariselkä, Finland iii) Dogmas, science and new frontiers - immunological determinants of pneumococcal carriage; June 2011, Helsinki, Finland

  • engagement with the regulatory authorities at the workshops on colonization

  • specific discussions with the regulatory authorities to reach agreement on the data needed for the use of VEcol as part of the licensure pathway.

The PneumoCarr outputs

The concrete output from the PneumoCarr work will be the “Case for Carriage” document (C4C). This document will include a concise summary of the evidence gathered by the PneumoCarr consortium to support consideration of VEcol in the pneumococcal vaccine licensure pathway. In other words, C4C will form a package of evidence to be used in delivery of the PneumoCarr findings in a convincing and influential way to the key audiences (i.e. regulators, manufacturers, international bodies and other stakeholders). The C4C document is expected to be finalized on the third quarter of year 2011.

In addition, four PneumoCarr Review articles are being written and included as appendices in the C4C document. These review articles will cover the following topics:

  • relationship between pneumococcal carriage and disease
  • diagnostics of pneumococcal carriage
  • indirect effects and public health impact of pneumococcal vaccination
  • design of vaccine trials with colonization end point

We have also constructed a unified project database to store datasets on colonization from all PneumoCarr partners. All data sets have been stored using the same structure, which allows easy switching between sets and a possibility to create supersets for comparative analyses. The data storage has resulted in a robust platform that suits for most study designs and can be used as a guideline for future trials. The database will be maintained by THL and it is available for further analyses by all PneumoCarr partners.

The datasets stored in the PneumoCarr database have continuously been used in several analyses that have led to a number of publications in good quality peer reviewed scientific journals (see Publications). These publications on relevant aspects of the project will further support the C4C document and the review articles.