NCT06894901

Brief Summary

This randomized controlled trial aims to evaluate the efficacy of Wolbachia-infected male mosquitoes combined with sterile insect technique (IIT-SIT) to mitigate active dengue transmission in Singapore.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Mar 2025Jan 2028

First Submitted

Initial submission to the registry

March 11, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

March 20, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2028

Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

2.3 years

First QC Date

March 11, 2025

Last Update Submit

March 19, 2025

Conditions

Dengue

Outcome Measures

Primary Outcomes (2)

  • Impact of male Wolbachia-Aedes deployments on the time to cluster extinction

    In this analysis, male Wolbachia-Aedes exposure will be considered as a binary classification based on whether the dengue cluster is allocated to the intervention or control arm. Cox proportional hazards models will be used to assess the intervention effect of male Wolbachia-Aedes by estimating the hazards ratio, which compares the probability of cluster extinction between arms from following up clusters from enrolment to cluster extinction.

    Up to 3 years

  • Impact of male Wolbachia-Aedes deployments on final cluster size, as measured by the difference in final cluster size between arms

    In this analysis, male Wolbachia-Aedes exposure will be considered as a binary classification based on whether the dengue cluster is allocated to the intervention or control arm. Negative binomial models will be used to assess the intervention effect of male Wolbachia-Aedes by estimating the average treatment effect of the intervention on the final number of dengue cases in intervention versus control clusters.

    Up to 3 years

Secondary Outcomes (3)

  • Impact of male Wolbachia-Aedes deployments on the prevalence of Ae. aegypti/Ae. albopictus mosquitoes

    Up to 3 years

  • Impact of male Wolbachia-Aedes deployments on dengue risk in clusters, measured by odds ratio of Wolbachia exposure distribution among laboratory-confirmed reported dengue cases compared to test-negative controls

    Up to 3 years

  • Impact of male Wolbachia-Aedes deployments on the individual level reproduction number

    Up to 3 years

Study Arms (2)

Intervention clusters

EXPERIMENTAL

Dengue clusters in residential estates that receive releases of male Wolbachia-infected Aedes aegypti

Biological: Biological (Male Wolbachia-infected Aedes aegypti)

Non-intervention clusters

NO INTERVENTION

Dengue clusters in residential estates that do not receive releases of male Wolbachia-infected Aedes aegypti

Interventions

Biological (Male Wolbachia-infected Aedes aegypti)BIOLOGICAL

Releases of male Wolbachia-infected Aedes aegypti mosquitoes

Intervention clusters

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Eligible dengue clusters will be limited to public housing estates and with at least 10 dengue cases comprising that dengue cluster before allocation into intervention or control arms. The selected clusters will be in areas with relatively high sector-level GAI of at least 0.2 at the time of the 10th reported case. Additionally, the first 10 cases must be reported within 30 days of the first case. Additionally, clusters must be in areas which have never experienced Wolbachia-Aedes releases and at least 700 m away from existing Wolbachia-Aedes release areas.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Environment Agency

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Dengue

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

  • Lee Ching Ng Group Director (Environmental Health Institute), PhD

    Environmental Health Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee Ching Ng, PhD

CONTACT

+65 67719108NG_Lee_Ching@nea.gov.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Group Director (Environmental Health Institute)

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 25, 2025

Study Start

March 20, 2025

Primary Completion (Estimated)

July 20, 2027

Study Completion (Estimated)

January 20, 2028

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)