In this Issue of the PDVI News, we provide an overview of PDVI activities and then focus on one of the major programs of the Initiative, the development of diagnostics. In later issues, we will summarize other portions of the PDVI Program.

The PDVI has designed four major programs for implementation by the end of 2010.

Formation and operation of Strategic Partnerships: The success of dengue vaccine evaluation and introduction will rest on formation and operation of partnerships with public and private organizations. The PDVI will join or form partnerships with organizations developing and evaluating dengue vaccines and diagnostics and with public sector organizations involved in introduction of vaccines into national immunization programs.

Supportive Research & Development: There exists a strong development pipeline for dengue vaccines. However, a range of research and development activities is required to advance candidate dengue vaccines to large-scale clinical testing.
Gaps exist in the diagnostic tests and assays required to evaluate dengue vaccines. PDVI will undertake activities directed at development, evaluation and standardization of diagnostic tests for acute dengue virus infection, and improved assays to measure immunity to dengue virus infection and to identify persons at risk of antibody enhanced disease.

Vaccine Evaluation: The PDVI will undertake activities to support evaluation of dengue vaccines in large-scale clinical trials (Phase 2b, Phase 3) and population-based effectiveness studies. Activities include creation of a consortium of vaccine evaluation field sites in dengue endemic countries; working with partners to revise guidelines for evaluation of the efficacy, safety and effectiveness of dengue vaccines in large-scale clinical trials; and developing provisional dengue vaccination strategies.

Vaccine Access: Decision makers require robust estimates of the disease and economic burden attributable to dengue and of the economic impact and effectiveness of dengue vaccination strategies. These data will support investments by private and public partners to make dengue a vaccine preventable disease. In addition, PDVI will work with partners to develop and promote plans for national and international vaccine procurement and distribution and develop effective communications about dengue as a vaccine preventable disease.