Impact of Wolbachia Deployment on Arboviral Disease Incidence in Medellin and Bello, Colombia

NCT03631719 | Completed DMC

• 2 other identifiers: PEC004_18PECET-002
• Study Type: observational
• Target: 834
• Locations: 1 country
• Sites: 1

Brief Summary

Study setting: Medellin and Bello municipalities, Colombia Health condition(s) studied: Dengue, Zika and chikungunya virus infection Intervention: Deployment of Wolbachia-infected Aedes aegypti mosquitoes in Medellin and Bello. Study design:

1. 1.An interrupted time-series analysis utilising routine disease surveillance data collected by the Medellín and Bello Health Secretariats, which aims to compare incidence of dengue, chikungunya and Zika pre- and post-Wolbachia release.
2. 2.A test-negative study using an incident case-control design, which aims to quantify the reduction in disease incidence among people living within a Wolbachia-treated zone compared with an untreated zone that has a similar dengue risk profile at baseline.

Conditions

Dengue; Chikungunya Virus Infection; Zika Virus Infection

Keywords

Wolbachia; Colombia; Dengue; Zika; Chikungunya; Arboviral diseases; Disease surveillance

Outcome Measures

Primary Outcomes (2)

• Dengue cases notified to surveillance system

  Incidence of dengue cases (suspected, epidemiological link, and IgM positive for dengue) notified to the disease surveillance system

  5 years

• Virologically-confirmed dengue

  Virologically-confirmed dengue virus infection in patients reporting febrile illness recruited from health clinics. Participants are classified as dengue cases if plasma samples collected 1-4 days after onset of fever test positive for dengue virus NS1 antigen or dengue virus nucleic acid by RT-qPCR.

  2 years

Secondary Outcomes (7)

• IgM test positive for dengue

  5 years

• Severe dengue cases

  5 years

• Zika cases notified to surveillance system

  5 years

• Chikungunya cases notified to surveillance system

  5 years

• Spatial analysis

  5 years

Study Arms (2)

Early-release

Resident in areas that receive early Wolbachia deployments.

Biological: Wolbachia-carrying Ae.aegypti mosquitoes

Late-release

Resident in areas that receive late Wolbachia deployments.

Interventions

Wolbachia-carrying Ae.aegypti mosquitoes BIOLOGICAL

Wolbachia-infected Ae. aegypti mosquito eggs and adults sequentially deployed into Medellin and Bello, Colombia. Deployments cease once Wolbachia prevalence has reached a predetermined frequency (usually ≥60%).

Early-release

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The case-control study area as a whole has a population of approximately 564,000, of which approximately half will be resident in areas that receive early Wolbachia deployments ('early-release') and half in areas that will receive late Wolbachia deployments ('late-release'). The study population for measurement of the efficacy endpoint is the population of patients who reside in the study area, presenting to the network of participating primary health care facility with febrile illness, and meeting the eligibility criteria.

You may qualify if:

• Fever (either self-reported or objectively measured, e.g. axillary temperature ≥38oC, with a date of onset between 1-4 days prior to the day of presentation.
• Aged ≥3 years old.
• Lived (i.e. slept) in the study area every night (or day) for the 10 days preceding illness onset.

You may not qualify if:

• Localising features suggestive of a specific diagnosis e.g. severe diarrhea, otitis, pneumonia
• Prior enrollment in the study within the previous 4 weeks.

Sponsors & Collaborators

• Universidad de Antioquia: lead
• Monash University: collaborator
• United States Agency for International Development (USAID): collaborator
• Bill and Melinda Gates Foundation: collaborator
• Wellcome Trust: collaborator

Study Sites (1)

Universidad de Antioquia

Medellín, Antioquia, Colombia

Location

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Related Links

• PECET Web Page

Biospecimen

Retention: SAMPLES WITH DNA

6 ml venous blood sample for DENV, chikungunya virus (CHIKV), and Zika virus (ZIKV) diagnostic testing

MeSH Terms

Conditions

Dengue; Chikungunya Fever; Zika Virus Infection

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Alphavirus Infections; Togaviridae Infections

Study Officials

• Cameron Simmons, Prof.

  Monash University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 15, 2018
• Study Start: October 25, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)