Impact of Project Wolbachia - Singapore on Dengue Incidence

NCT05505682 | Completed

• 1 other identifier: IRB024
• Study Type: interventional
• Target: 724,428
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a cluster-randomised controlled trial set in Singapore, to assess if the deployment of male Wolbachia-infected Aedes aegypti mosquitoes can reduce dengue incidence in intervention clusters.

Conditions

Dengue

Outcome Measures

Primary Outcomes (2)

• Odds ratio of Wolbachia exposure distribution among laboratory-confirmed reported dengue cases compared to test-negative controls

  Dengue cases and dengue test-negative controls data will be obtained from the national surveillance network of diagnostic laboratories which receive samples for dengue testing.

  Up to 3 years

• Laboratory-confirmed reported dengue case counts normalized by population size in intervention versus non-intervention clusters

  Dengue cases data will be obtained from the national surveillance network of diagnostic laboratories which receive samples for dengue testing.

  Up to 3 years

Secondary Outcomes (2)

• Prevalence of Ae. aegypti/Ae. albopictus mosquitoes

  Up to 3 years

• Public Attitudes, Perceptions & Knowledge (APK) of Wolbachia and other vector control interventions

  Up to 3 years

Study Arms (2)

Intervention clusters

EXPERIMENTAL

Residential areas that receive releases of male Wolbachia-infected Aedes aegypti

Biological: Biological (Male Wolbachia-infected Aedes aegypti)

Non-intervention clusters

NO INTERVENTION

Residential areas 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

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Dengue-suspected patients living in the intervention and non-intervention clusters whose blood samples are collected by a national network of diagnostic laboratories that support private clinics, public polyclinics, or public/private hospitals.
• Test positive cases: Patients with virologically confirmed DENV infection through RT-qPCR, testing positive for NS1 antigen or IgM. A positive test for any of the three assays would classify the patient as a dengue case.
• Test negative controls: Patients with negative test results for DENV through RT-qPCR, NS1 antigen ELISA, or DENV IgM.

Sponsors & Collaborators

• National Environment Agency, Singapore: lead
• Ministry of Health, Singapore: collaborator

Study Sites (1)

National Environment Agency

Singapore, Singapore

Location

Related Publications (4)

• Anders KL, Indriani C, Ahmad RA, Tantowijoyo W, Arguni E, Andari B, Jewell NP, Rances E, O'Neill SL, Simmons CP, Utarini A. The AWED trial (Applying Wolbachia to Eliminate Dengue) to assess the efficacy of Wolbachia-infected mosquito deployments to reduce dengue incidence in Yogyakarta, Indonesia: study protocol for a cluster randomised controlled trial. Trials. 2018 May 31;19(1):302. doi: 10.1186/s13063-018-2670-z.

  PMID: 29855331 BACKGROUND

• Utarini A, Indriani C, Ahmad RA, Tantowijoyo W, Arguni E, Ansari MR, Supriyati E, Wardana DS, Meitika Y, Ernesia I, Nurhayati I, Prabowo E, Andari B, Green BR, Hodgson L, Cutcher Z, Rances E, Ryan PA, O'Neill SL, Dufault SM, Tanamas SK, Jewell NP, Anders KL, Simmons CP; AWED Study Group. Efficacy of Wolbachia-Infected Mosquito Deployments for the Control of Dengue. N Engl J Med. 2021 Jun 10;384(23):2177-2186. doi: 10.1056/NEJMoa2030243.

  PMID: 34107180 BACKGROUND

• Lim JT, Mailepessov D, Chong CS, Chang CC, Dickens B, Lai YL, Deng L, Lee C, Tan LY, Chain G, Ho SH, Zulkifli MF, Liew J, Vasquez K, Lee V, Wong JCC, Sim S, Tan CH, Ng LC. Update to: Assessing the efficacy of male Wolbachia-infected mosquito deployments to reduce dengue incidence in Singapore. Trials. 2024 Jun 20;25(1):400. doi: 10.1186/s13063-024-08148-z.

  PMID: 38902790 DERIVED

• Ong J, Ho SH, Soh SXH, Wong Y, Ng Y, Vasquez K, Lai YL, Setoh YX, Chong CS, Lee V, Wong JCC, Tan CH, Sim S, Ng LC, Lim JT. Assessing the efficacy of male Wolbachia-infected mosquito deployments to reduce dengue incidence in Singapore: study protocol for a cluster-randomized controlled trial. Trials. 2022 Dec 17;23(1):1023. doi: 10.1186/s13063-022-06976-5.

  PMID: 36528590 DERIVED

MeSH Terms

Conditions

Dengue

Interventions

Biological Products

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Lee Ching Ng, PhD

  Group Director (Environmental Health Institute)

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Parallel, two-arm, non-blinded cluster-randomised controlled trial

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: August 18, 2022
• Study Start: July 28, 2022
• Primary Completion: September 13, 2024
• Study Completion: September 13, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)