The PDVI will undertake activities to support evaluation of dengue vaccines in large-scale clinical (Phase 2b, Phase 3) and population-based effectiveness trials (Phase 4), and create a consortium of field sites with the capacity to host such trials. The PDVI will work with partners to achieve evidence-based agreement on design of large-scale clinical trials and to develop provisional dengue vaccination strategies.

Based on extensive consultation with experts in the field, including vaccine manufacturers, the PDVI is in the process of establishing a consortium of field sites to conduct real-time dengue surveillance, perform standardized diagnostic testing and develop capacity to conduct clinical trials. These sites could be used for vaccine evaluation and other dengue-related studies. This consortium would be composed of sites fully or partially funded by PDVI, or funded by another sponsor. All members of the Consortium would agree to share surveillance data on dengue, standardize laboratory diagnostic protocols and methods, and diagnostic case definitions.

Development of the scientific basis for design of clinical trials and a provisional dengue vaccination strategy will be done in close collaboration with WHO. These program activities would involve a series of meetings, with conclusions updated as new clinical trial experience, information about performance of the respective vaccines, and epidemiologic data become available. Coordination to eliminate duplication of efforts or having outcomes which are at cross-purposes to each other would be achieved by working through PDVI’s strategic partnerships.

The development of an effective consortium of field sites capable of vaccine evaluation will require substantial technical support from the PDVI. This support would include direct funding for some sites, staff and funding support to ensure that all sites achieve common core capacities of active dengue surveillance, standardized dengue diagnostic testing, and clinical and epidemiologic record keeping which meets standards of good clinical practices. In addition, PDVI staff would regularly visit field sites to work with staff. Principle investigators from respective sites would meet regularly to present data and discuss site management, and the sites would be tied together with an internet-based, data management and surveillance reporting system.

The PDVI has initiated formal discussions with WHO on how best to provide the scientific information needed to revise the current Guidelines for Evaluation of Flavivirus Vaccines. Planning has begun for what will most likely become a series of scientific forums to address issues of dengue trial design and evaluation, and implementation of a dengue vaccination strategy.