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Structure
Task Force on Harmonization of Assays for TB Vaccine Development
Objectives:
- To review experiences and results with use of the immune assays in the first completed phase I/II trials of TB vaccine candidates;
- To evaluate clinical site and laboratory requirements
- To screen the horizon to identify new, more informative markers and/or assays (newer cytokines, functional assays, combination of assays, etc);
- To initiate a consensus building process with the objective of agreeing on at least one informative assay in all upcoming TB vaccine trials;
- To define optimization and validation requirements in 'consensus' assays
Task Force on Clinical Research Issues in TB Vaccine Development
Objectives:
- Define endpoints to be used in paediatric, adolescent and adult TB vaccine trials.
- Standardise TB diagnostic tools for use in TB vaccine trials.
- Develop a diagnostic algorithm for use in paediatric vaccine trials.
- Facilitate a clinical trials network involving multiple sites.
Task Force on New Approaches to TB Vaccine Development ("out of-the-box")
Objectives:
- To identify fundamentally new approaches to prevention of TB.
- To develop mechanisms to attract investigators from other disciplines and specialists on diseases other than TB diseases to develop innovative TB vaccine research proposals.
- To provide young TB researchers at PhD students and post-doc level with incentives to develop and test innovative ideas.
- To identify funding opportunities/pathways for high-risk research on next (third?) generation TB vaccination approaches.
- To develop a mechanism to ensure rapid transition of innovative TB vaccine discovery approaches into a standardized vaccine development pathway.
Task Force on Economics and Product Profiles for New TB Vaccines
Objectives:
- To develop estimates of the economic value of new TB vaccines/vaccine types in different epidemiologic scenarios:
- as an advocacy tool for donors to TB vaccine development
- as guidance for phased introduction of (initially limited) supplies of new TB vaccines
- To elaborate financing models/options for the introduction of new TB vaccines.
- To initiate a dialogue between vaccine developers and the vaccine implementation community regarding definition of realistic and useful target product profiles.
- To develop models that allow to place new TB vaccines into the context of (a) existing and in particular new tools in TB control and (b) mid-and long-term trends in the overall vaccine market (time horizon 10-20 years).
Task Force on Advocacy, Communication and Social Mobilization
Objectives:
- To develop an advocacy strategy for new TB vaccine development.
- To ensure adequate representation of TB vaccine development/implementation/ financing issues in international public health fora.
- To provide potential donors with a realistic picture of the TB epidemic and the potential role of a new vaccine in that context.
- To inform endemic country governments and affected communities of the prospects and challenges for new TB vaccines and the importance of their participation.
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