Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04514107
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2020-08-13
Brief Title:
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
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Cluster-Randomized Trial to Evaluate the Efficacy of Wolbachia-Infected Aedes Aegypti Mosquitoes in Reducing the Incidence of Arboviral Infection in Brazil
Status:
RECRUITING
Status Verified Date:
2024-05-29
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 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
Of note due to widespread dengue epidemic in Brazil and the introduction of the dengue vaccination campaign by the Ministry of Health all children ages 10-14 received Odenga Since vaccination precludes the ability to assess for flavivirus seroconversion participants eligible to receive the vaccination the Year 5 annual sample may be collected earlier than the study window The Visit 05 sample for these subjects will be obtained prior or up to 14 days after dengue vaccination the optimal cut-off time for the detection of vaccine-induced neutralizing antibodies is to be determined and will be explained in more detail in the SAP Those who have this earlier visit will also have Visit 06 during the expected study window The Visit 06 sample will be used for serologic assay wherever available and appropriate considering dengue vaccination status and Visit 05 samples in all other circumstances
The primary objective is to evaluate whether release of Wolbachia-infected Aedes aegypti mosquitoes plus standard Aedes vector control measures reduce 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 releases 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 serotypes at study entry compared to standard Aedes vector control measures alone 8 To use model-based geostatistics to estimate the proportion and abundance of Wolbachia-infected and wildtype Aedes aegypti mosquitoes in intervention clusters during the study period 9 To use model-based geostatistics to estimate the proportion and abundance of Wolbachia-infected and wildtype Aedes aegypti mosquitoes in control clusters during the study period
Of note due to widespread dengue epidemic in Brazil and the introduction of the dengue vaccination campaign by the Ministry of Health all children ages 10-14 received Odenga Since vaccination precludes the ability to assess for flavivirus seroconversion participants eligible to receive the vaccination the Year 5 annual sample may be collected earlier than the study window The Visit 05 sample for these subjects will be obtained prior or up to 14 days after dengue vaccination the optimal cut-off time for the detection of vaccine-induced neutralizing antibodies is to be determined and will be explained in more detail in the SAP Those who have this earlier visit will also have Visit 06 during the expected study window The Visit 06 sample will be used for serologic assay wherever available and appropriate considering dengue vaccination status and Visit 05 samples in all other circumstances
The primary objective is to evaluate whether release of Wolbachia-infected Aedes aegypti mosquitoes plus standard Aedes vector control measures reduce 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 releases 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 serotypes at study entry compared to standard Aedes vector control measures alone 8 To use model-based geostatistics to estimate the proportion and abundance of Wolbachia-infected and wildtype Aedes aegypti mosquitoes in intervention clusters during the study period 9 To use model-based geostatistics to estimate the proportion and abundance of Wolbachia-infected and wildtype Aedes aegypti mosquitoes in control clusters during the study period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None