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Published on: March 13, 2018
Dengue surveillance in preparation for field vaccine trials
1Pediatric Dengue Vaccine Initiative, International Vaccine Institute, Seoul, Korea. bletson@pdvi.org
Insights
Establishing international, coordinated laboratory surveillance for dengue fever is crucial for vaccine trials and introduction. The Pediatric Dengue Vaccine Initiative (PDVI) created a consortium to harmonize surveillance, ensuring data comparability and readiness for clinical trials.
Area of Science:
- * Global Health
- * Infectious Diseases
- * Vaccinology
Background:
- * Dengue fever poses a significant global health challenge, necessitating effective vaccines.
- * International, coordinated laboratory-based surveillance is essential for dengue vaccine development and implementation strategies.
Purpose of the Study:
- * To describe the development and function of an international consortium for dengue surveillance.
- * To outline criteria for selecting sites for dengue vaccine trials.
- * To discuss endpoints for dengue vaccine trials.
Main Methods:
- * Establishment of an international consortium of field sites by the Pediatric Dengue Vaccine Initiative (PDVI) in Latin America and Asia.
- * Implementation of community-based and enhanced passive laboratory-based surveillance for dengue fever.
- * Harmonization of laboratory surveillance processes for inter-regional and international data comparison.
Main Results:
- * The PDVI consortium facilitates standardized surveillance, preparing sites for Good Clinical Practice (GCP) standards required for vaccine trials.
- * Site selection criteria include endemic disease presence, low migration, flavivirus epidemiology data, robust medical infrastructure, political stability, and commitment to trials.
- * Prevention of dengue fever is identified as a suitable primary endpoint for proof-of-concept trials.
Conclusions:
- * Harmonized laboratory surveillance is critical for successful dengue vaccine trials and informed vaccine introduction.
- * Community-based demonstration trials may be required for comprehensive outcome analysis stratified by risk factors and serotypes.
- * The PDVI model provides a framework for global dengue surveillance and vaccine preparedness.
Abstract:
Preparations for dengue vaccine trials as well as vaccine introduction strategies require laboratory-based surveillance on an international and coordinated level. The Pediatric Dengue Vaccine Initiative (PDVI) has developed an international consortium of field sites in Latin America and Asia. These sites conduct community- based and enhanced passive laboratory-based surveillance of dengue fever. Through this consortium, PDVI is facilitating harmonized laboratory-based surveillance processes, so that disease incidence can be compared between different regions and countries. This process prepares sites for the rigorous case detection, diagnosis, recording and analysis to meet good clinical practice standards necessary for clinical dengue vaccine trials. In addition to several years of laboratory-based dengue surveillance data, dengue vaccine trial site criteria include low population migration of an endemic disease area, documentation of other local flavivirus epidemiology, good medical infrastructure, political stability, and country and target population commitment to vaccine trials and need for vaccine. Prevention of dengue fever is the most suitable primary end point for a proof-of-concept dengue vaccine trial. However, such trials may provide insufficient information for stratified analysis of outcomes according to varied risk factors and virus serotype. Consequently large community-based demonstration trials may be necessary.
