Prospective cohort study with active surveillance for fever in four dengue endemic countries in Latin America

Insights

This study assessed dengue incidence in children preparing for a vaccine trial. Results show sites can detect dengue cases and febrile episodes, supporting future efficacy studies.

Area of Science:

  • * Clinical research
  • * Infectious diseases
  • * Vaccinology

Background:

  • * Preparation for a Phase III dengue vaccine efficacy trial required understanding local dengue incidence.
  • * An observational study was conducted in a cohort of children aged 9-16 years.

Purpose of the Study:

  • * To identify dengue infections within a defined pediatric cohort.
  • * To evaluate the capability of investigational sites in detecting dengue cases and febrile episodes.

Main Methods:

  • * Observational study involving 3,000 children aged 9-16 years across 20 sites.
  • * Monitoring of acute febrile episodes and serological/virological confirmation of dengue.
  • * Calculation of incidence density for febrile episodes and dengue cases.

Main Results:

  • * 50 probable dengue cases (21.3%) and 18 confirmed dengue cases (7.7%) were identified from 255 febrile episodes.
  • * Overall incidence density of acute febrile episodes was 17.7 per 100 person-years.
  • * Incidence varied by location, from 15.3 in Colombia to 22.0 in Puerto Rico.

Conclusions:

  • * Investigational sites demonstrated capacity to capture and follow acute febrile episodes.
  • * The study successfully detected dengue cases, validating site readiness for the Phase III trial.
  • * Findings provide crucial epidemiological data for dengue vaccine efficacy assessment.

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