Status:
COMPLETED
A Cluster-randomized Trial to EValuate the Efficacy of Wolbachia-InfecTed Aedes Aegypti Mosquitoes in Reducing the Incidence of Arboviral Infection in Brazil (EVITA Dengue)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Dengue Fever
Eligibility:
All Genders
6-11 years
Phase:
NA
Brief Summary
This is a cluster randomized controlled trial (CRCT) to evaluate the efficacy of Wolbachia-infected A. aegypti mosquito releases in reducing the burden of ARBV infection in Brazil over four years. The...
Detailed Description
This is a cluster randomized controlled trial (CRCT) to evaluate the efficacy of Wolbachia-infected A. aegypti mosquito releases in reducing the burden of ARBV infection in Brazil over four years. The...
Eligibility Criteria
Inclusion
- Children aged 6-11 years at enrollment.
- Child's parent or legal guardian agrees to provide written informed consent.
- Child agrees to provide informed assent.
- Child is enrolled in a public school selected for this trial (and which define the clusters).
- Child resides within geographic boundaries at least 5 days a week in the cluster area corresponding to his/her school.
Exclusion
- Children planning to move outside of the cluster boundary within the study period.
- Child has poor venous access.
- Child has received an experimental or licensed vaccine against dengue, Zika or chikungunya at enrollment. Participants who received a dengue, Zika or CHIK vaccine after enrollment will not be excluded.
- Child has any medical condition that would prevent them from completing a blood draw.
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2024
Estimated Enrollment :
5757 Patients enrolled
Trial Details
Trial ID
NCT04514107
Start Date
September 9 2020
End Date
October 29 2024
Last Update
November 25 2025
Active Locations (1)
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1
Universidade Federal de Minas Gerais, Instituto de Ciencias Biologicas, Department of Biochemistry and Immunology
Belo Horizonte, Minas Gerais, Brazil, 31275-030