|
The work on dengue at IVI is carried out by the Pediatric
Dengue Vaccine Initiative (PDVI).
The PDVI Program
Dengue fever is a mosquito-borne disease, primarily of children, which occurs in all
tropical countries. Dengue fever, with its severe consequences of dengue haemorrhagic
fever (DHF) and dengue shock syndrome (DSS), results in substantial morbidity,
mortality and economic losses. The magnitude of these consequences is significant and is
comparable to those of other infectious diseases of children.
Dengue can become a vaccine preventable disease. The disease is caused by four
Flaviviruses - dengue types 1 – 4. Other Flavivirus diseases- namely, yellow fever,
Japanese encephalitis and tick borne encephalitis – are controlled by effective vaccines.
.
A number of dengue vaccine candidates are in different stages of pre-clinical and clinical
evaluation. However, none has entered clinical trials to determine efficacy, effectiveness
and safety.
Dengue is one of the more challenging vaccines presently under evaluation. A dengue
vaccine must provide protection against infection by four different viruses. The vaccine
must provide durable, long-term protection against infection with all dengue viruses
because of the unique ability of some infections to produce severe consequences in
persons previously infected with another dengue virus (immune enhancement). In
addition, there is the need for new and improved dengue diagnostics and assays for
vaccine evaluation and for monitoring the effectiveness of vaccination programs.
This Strategic Plan provides a long-term vision for accelerating evaluation of candidate
dengue vaccines and introduction of safe, effective and affordable vaccines in the
national immunization programs of dengue endemic countries. It also lays out required
activities to accelerate development and evaluation of new and improved dengue
diagnostics and assays.
The Plan defines the role of the Pediatric Dengue Vaccine Initiative (PDVI) in achieving
this accelerated progress. The PDVI is a program of the International Vaccine Institute,
Seoul, Korea and is funded by the Bill and Melinda Gates Foundation and the
Rockefeller Foundation.
Goals
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:
Robust estimates of the disease and economic burden
attributable to dengue and of the economic and prevention effectiveness of
dengue vaccination strategies are required to support investment 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.
This Strategic Plan identifies specific objectives to ensure the achievement of each of
these program goals. Progress toward these objectives can be measured by the
milestones described in this Plan.
|
|
|
