- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04514107
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)
May 9, 2024 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
A Cluster-Randomized Trial to Evaluate the Efficacy of Wolbachia-Infected Aedes Aegypti Mosquitoes in Reducing the Incidence of Arboviral Infection in Brazil
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 threefour years.
The intervention will be the release of Wolbachia-infected A. aegypti mosquitoes.
Standard control measures routinely established by the Belo Horizonte City Hall as recommended by the PNCD, will continue to be performed by the Belo Horizonte Health Department (Zoonoses Management) in all clusters, that is, the standard control measures will be carried out throughout the city of Belo Horizonte, independent of this clinical study.
Wolbachia-infected A. aegypti will be deployed by releasing adult mosquitoes in pre-determined, thoroughly spaced release points in easily accessible roads described in a release map.
A release map will be generated for each cluster and the numbers of release points will be determined by population density, surface area and mosquito abundance.
Wolbachia-infected A. aegypti mosquitoes will be deployed across intervention clusters in two stages: 1) a 4 month establishment stage in which most of the releases will occur and 2) followed by an 8 month consolidation stage in which the abundance of Wolbachia-infected mosquitoes will be measured and remedial deployments will be completed, if needed, with the aim of achieving a high prevalence of Wolbachia amongst A. aegypti mosquitoes in intervention clusters within 12 months from the start of the release.
The goal is to reach a Wolbachia prevalence of 60% or higher.
Monitoring of Wolbachia prevalence in the cluster will continue throughout the study period, but no further mosquito deployments will occur after the consolidation stage is complete.
The primary objective is to evaluate whether release of Wolbachia-infected Aedes aegypti mosquitoes plus standard Aedes vector control measures reduces the sero-incidence of ARBV infection compared to standard Aedes vector control measures alone.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 threefour years.
The intervention will be the release of Wolbachia-infected A. aegypti mosquitoes.
Standard control measures routinely established by the Belo Horizonte City Hall as recommended by the PNCD, will continue to be performed by the Belo Horizonte Health Department (Zoonoses Management) in all clusters, that is, the standard control measures will be carried out throughout the city of Belo Horizonte, independent of this clinical study.
Wolbachia-infected A. aegypti will be deployed by releasing adult mosquitoes in pre-determined, thoroughly spaced release points in easily accessible roads described in a release map.
A release map will be generated for each cluster and the numbers of release points will be determined by population density, surface area and mosquito abundance.
Wolbachia-infected A. aegypti mosquitoes will be deployed across intervention clusters in two stages: 1) a 4 month establishment stage in which most of the releases will occur and 2) followed by an 8 month consolidation stage in which the abundance of Wolbachia-infected mosquitoes will be measured and remedial deployments will be completed, if needed, with the aim of achieving a high prevalence of Wolbachia amongst A. aegypti mosquitoes in intervention clusters within 12 months from the start of the release.
The goal is to reach a Wolbachia prevalence of 60% or higher.
Monitoring of Wolbachia prevalence in the cluster will continue throughout the study period, but no further mosquito deployments will occur after the consolidation stage is complete.
The primary objective is to evaluate whether release of Wolbachia-infected Aedes aegypti mosquitoes plus standard Aedes vector control measures reduces the sero-incidence of ARBV infection compared to standard Aedes vector control measures alone.
The Secondary objectives are 1.)
To evaluate whether release of Wolbachia-infected Aedes aegypti mosquitoes plus standard Aedes vector control measures reduces the sero-incidence of ARBV infection, inferred from model-based reconstruction of serological dynamics compared to standard Aedes vector control measures alone; 2.) To evaluate whether release of Wolbachia-infected Aedes aegypti mosquitoes plus standard Aedes vector control measures reduces the sero-incidence of FLAV or CHIKV infection amongst individuals who are seronegative to each of these viruses, respectively, at study entry, compared to standard Aedes vector control measures alone; 3.) To evaluate whether release of Wolbachia-infected Aedes aegypti mosquitoes plus standard Aedes vector control measures reduces the overall sero-incidence of FLAV (DENV + ZIKV) infection; 4.) To evaluate whether release of Wolbachia-infected Aedes aegypti mosquitoes plus standard Aedes vector control measures reduces the sero-incidence of DENV infection; 5.) To evaluate whether release of Wolbachia-infected Aedes aegypti mosquitoes plus standard Aedes vector control measures reduces the sero-incidence of ZIKV infection; 6.) To evaluate whether release of Wolbachia-infected Aedes aegypti mosquitoes plus standard Aedes vector control measures reduces the sero-incidence of CHIKV infection among those who are CHIKV seronegative at baseline; 7.) To evaluate whether release of Wolbachia-infected Aedes aegypti mosquitoes plus standard Aedes vector control measures reduces the sero-incidence of DENV infection amongst individuals who are seropositive to any DENV serotype(s) at study entry, compared to standard Aedes vector control measures alone; 8.) To evaluate the extent to proportion of Wolbachia-infected Aedes aegypti mosquitoes in intervention clusters during the study period; 9.) To evaluate the proportion of Wolbachia-infected Aedes aegypti mosquitoes in control clusters during the study period.
Study Type
Interventional
Enrollment (Estimated)
3480
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Srilatha Edupuganti
- Phone Number: 14047121434
- Email: sedupug@emory.edu
Study Locations
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brazil, 31275-030
- Recruiting
- Universidade Federal de Minas Gerais, Instituto de Ciencias Biologicas, Department of Biochemistry and Immunology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
- Child has any medical condition that would prevent them from completing a blood draw.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
29 school-based clusters of healthy individuals, age 6-11, exposed to standard vector control efforts recommended by the Brazilian National Dengue Control Program (PNCD).
n=1740
|
This program has 4 basic principles: 1) Adequate case finding, classification and treatment; 2) Epidemiological surveillance and reporting of all cases; 3) Mobilization and communication of risks to the public; 4) mosquito monitoring and control which consists fundamentally of detection of larva using a rapid larval index (LIRAa) followed by removal of breeding sites and local spraying.
|
Experimental: Intervention
29 school-based clusters of healthy individuals, age 6-11, exposed to standard vector control efforts recommended by the Brazilian National Dengue Control Program (PNCD) and Wolbachia-infected Aedes aegypti (wMel) mosquitoes.
n=1740
|
This program has 4 basic principles: 1) Adequate case finding, classification and treatment; 2) Epidemiological surveillance and reporting of all cases; 3) Mobilization and communication of risks to the public; 4) mosquito monitoring and control which consists fundamentally of detection of larva using a rapid larval index (LIRAa) followed by removal of breeding sites and local spraying.
Brazilian strain of Aedes aegypti infected with Wolbachia pipientis released into geographic clusters.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of arbovirus (ARBV) infection
Time Frame: Year 2 through Year 4
|
Defined as seroconversion to flavivirus (FLAV) or chikungunya virus (CHIKV), as detected during annual serological evaluations.
|
Year 2 through Year 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of arbovirus (ARBV) infections, specifically due to flavivirus (FLAV) or chikungunya virus (CHIKV)
Time Frame: Year 2 through Year 4
|
As detected during annual serological evaluations; inferred from model-based reconstruction of serological dynamics
|
Year 2 through Year 4
|
Incidence of Chikungunya virus (CHIKV) infection is defined by seroconversion to CHIKV
Time Frame: Year 2 through Year 4
|
As detected during annual serological evaluations
|
Year 2 through Year 4
|
Incidence of Dengue virus (DENV) infection as defined by seroconversion to DENV
Time Frame: Year 2 through Year 4
|
As detected during annual serological evaluations
|
Year 2 through Year 4
|
Incidence of Dengue virus (DENV) infection is defined by seroconversion
Time Frame: Year 2 through Year 4
|
As detected during annual serological evaluations in the subgroup of participants who are seropositive at baseline (time of enrollment) to any DENV serotype(s) regardless of Zika Virus (ZIKV) serostatus
|
Year 2 through Year 4
|
Incidence of Flavivirus (FLAV) infection as defined by seroconversion to FLAV
Time Frame: Year 2 through Year 4
|
As detected during annual serological evaluations
|
Year 2 through Year 4
|
Incidence of Zika virus (ZIKV) infection is defined as seroconversion to ZIKV
Time Frame: Year 2 through Year 4
|
As detected during annual serological evaluations
|
Year 2 through Year 4
|
Incident Arbovirus (ARBV) infections, as defined by seroconversion to Flavivirus (FLAV)
Time Frame: Year 2 through Year 4
|
Among the subgroup of participants who have a Focus Reduction Neutralization Test (FRNT) 50 titer <1:20 at the baseline survey (time of enrollment) OR seroconversion to chikungunya virus (CHIKV)
|
Year 2 through Year 4
|
Proportion of Wolbachia-infected (PCR positive) Aedes aegypti (wMel) adults in control clusters
Time Frame: From Year 1 through Year 4
|
From Year 1 through Year 4
|
|
Proportion of Wolbachia-infected (PCR positive) Aedes aegypti (wMel) adults in intervention clusters
Time Frame: From Year 1 through Year 4
|
From Year 1 through Year 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 9, 2020
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
August 13, 2020
First Submitted That Met QC Criteria
August 13, 2020
First Posted (Actual)
August 14, 2020
Study Record Updates
Last Update Posted (Estimated)
May 10, 2024
Last Update Submitted That Met QC Criteria
May 9, 2024
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-0111
- HHSN272201300018I
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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