Wolbachia Mosquito Release for Dengue Fever

Recruiting at 1 trial location

Overseen By Srilatha Edupuganti

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Disqualifiers: Moving, Poor venous access, Vaccines, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

5757 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for children aged 6-11 who attend selected public schools within the study areas in Brazil. They must live there at least 5 days a week and have consent from a parent or guardian, as well as provide their own assent to participate.

Inclusion Criteria

I am between 6 and 11 years old.

Child is enrolled in a public school selected for this trial (and which define the clusters).

Child's parent or legal guardian agrees to provide written informed consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Establishment Stage

Deployment of Wolbachia-infected Aedes aegypti mosquitoes in intervention clusters

4 months

Consolidation Stage

Measurement of Wolbachia prevalence and remedial deployments to achieve high prevalence

8 months

Follow-up

Monitoring of Wolbachia prevalence and sero-incidence of ARBV infection

Year 1 through Year 5

Treatment Details

Interventions

• Wolbachia-infected Aedes aegypti

Trial Overview The trial tests if releasing Wolbachia-infected Aedes aegypti mosquitoes into the environment can reduce dengue fever infections when combined with standard control measures, compared to using standard measures alone over three to four years.

Participant Groups

Group I: Intervention Experimental Treatment 2 Interventions

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

Group II: Control Active Control 1 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). n=1740

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+