PneumoCarr

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:: Introduction to PneumoCarr project


Key Messages

The following three key messages were prepared as a result of discussions amongst participants at the September, 2008 PneumoCarr meeting in London.

What is the problem?

Pneumococcus is a major cause of mortality and morbidity that is vaccine-preventable. The current evaluation of pneumococcal vaccines for licensure is derived solely from immunogenicity data which may lead to decision-making based on insufficient information.

What is the solution?

Carriage of pneumococcus precedes disease and is the reservoir for spread between people. Understanding the impact of vaccine on carriage will advance decision-making for new and existing pneumococcal vaccines.

How do we arrive at that solution?

By combining statistical modelling, immunological studies and global epidemiological data, PneumoCarr is developing methods to predict vaccine effect on carriage. These methods will permit the selection of optimal dosing schedules, predict population effects of vaccine introduction and facilitate and expand licensure of vaccines.

Pneumococcal diseases are a common cause of death of children under 5 years of age

Acute respiratory infections (ARI) are the most common cause of death of children under 5 in developing countries. Streptococcus pneumoniae (the pneumococcus) is the most important cause of ARI. It is estimated to be responsible for 1 million deaths annually of the children with ARI.

A new vaccine recently developed against pneumococcus effectively prevents the most serious form of pneumococcal disease and also reduces nasopharyngeal colonization with pneumococci. Due to high research and development costs, however, the vaccine is too expensive for developing countries at the moment. Research that focuses on colonization yields results faster and more inexpensively.

Vaccine trials that focus on the efficacy of the vaccine in preventing disease are expensive and time-consuming. By contrast, trials that focus on bacterial colonization should produce results more quickly and inexpensively. One of the main argument of the of the research consortium is a new way of thinking about immunity to pneumococcal diseases, raising asymptomatic colonization to the foreground as the central point in development of pneumococcal disease and as the source ot its spread to new hosts (transmission).

Goals

The objectives of the project are to develop

  • the regulatory pathway for the use of vaccine efficacy against pneumococcal nasopharyngeal colonization (VE-colonization) as part of the licensure process, and
  • the recommendations for determination of the optimal use and the impact of pneumococcal conjugate vaccines (PCV) for public health purposes.

Objectives

The Project Objectives to meet the project goals: To develop

  • the scientific basis and analytic tools, and
  • the technical community understanding and acceptance.
These two objectives address the key obstacles to use of VE-colonization as a strategy for the development, licensure and implementation of new pneumococcal vaccine products.

Research centres from different parts of the world

The PneumoCarr consortium consists of nine research institutes, all performing at the highest levels of scientific quality and providing data sets complementary to each other in terms of study targets and designs. The main statistical modeling work as well as program coordination is carried out by the National Institute for Health and Welfare, Finland.
[list of partners]