Testing Combined IIT-SIT to Control Mosquito-Borne Diseases At Scale

March 16, 2026 updated by: Zhiyong Xi, Michigan State University

Testing a Combined Approach to Control Mosquito-Borne Diseases at Scale

Mosquito-borne diseases cause suffering for hundreds of millions of people and claim more than 700,000 lives yearly. Diseases such as dengue, Zika, and chikungunya cause symptoms similar to malaria and are endemic in many parts of the world, yet there are no treatments for them nor vaccines for Zika and chikungunya. Mosquito control, particularly of the Aedes aegypti species, is seen as a potentially effective solution to slow or stop the spread of these diseases but has not yet demonstrated significant, sustainable impacts on disease transmission. The investigators will aim to significantly control or eliminate local foci (hot-spots) of dengue, chikungunya and Zika transmission and significantly reduce disease transmission by implementing a combined incompatible and sterile insect technique (IIT-SIT) program based on the release of male Aedes aegypti carrying Wolbachia (wAlbB strain) that have been previously irradiated with X-rays (to minimize the chance of fertile female releases). The investigators will implement a two-arm cluster randomized controlled trial to evaluate the epidemiological and entomological impact of population suppression via IIT-SIT on Aedes-borne diseases in the city of Merida, Mexico. Primary endpoint of the trial is the incidence of laboratory Aedes-borne viruses detected by the passive surveillance system of Mexico. Secondary endpoints will allow estimating the level of suppression of Ae. aegypti populations. This trial design will allow establishing a link between epidemiologic, entomo-virological and entomological indicators to determine the effectiveness of IIT-SIT in real world conditions. The approach is novel because it effectively eliminate vectors, such as urban, outdoor, daytime biting mosquitoes, which are not susceptible to standard vector control approaches, by targeting cryptic and inaccessible mosquito habitats. In addition, the intervention has the below advantages comparing to existing alternatives: (i) highly competitive males are used for release as Wolbachia-infected males have the mating competitiveness equal to wild-type males; (ii) release can continue until population elimination is reached as a low dose of radiation is used to sterilize females for preventing risk of population replacement; (iii) any residual females contaminated in released male pools is resistant to pathogens; (iv) public acceptance of release of Wolbachia-infected males can be easily achieved, because Wolbachia are bacteria naturally presenting in ~50 percent of insect species, and male mosquitoes neither bite nor transmit diseases and can be self-limiting post release; (v) it will not impact non-target species. Successful findings from this study will pave the way for future expansions of the combined IIT-SIT to the entire city and nationwide using a rolling-carpet strategy, which has been successfully demonstrated for area-wide control of screwworm and medfly in Latin America.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15243

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Yucatán
      • Mérida, Yucatán, Mexico, 97160
        • Laboratorio para el Control Biolo´gico de Aedes aegypti (LCB-UADY), Universidad Autónoma de Yucatán

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All residents in the release sites will be included in the studies

Exclusion Criteria:

  • No exclusion will be performed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Release sites
Traditional mosquito control will be applied, followed by weekly release of Wolbachia wAlbB-infected Aedes aegypti males to induce sterile mating with wild female mosquitoes.
Genetic: Wolbachia induced incompatible mating
The intervention will be performed by weekly release of male Aedes aegypti carrying Wolbachia (wAlbB strain) to mate with wild females, resulting in the death of their eggs for birth control. Before release, these males will be irradiated with X-rays to minimize the chance of any residual fertile female releases. The intervention will lead to Ae. aegypti population suppression or even elimination and preventing dengue transmission in release sites.
Other Names:
  • Incompatible insect technique
  • Sterile insect technique
Combination product: Standard traditional chemical mosquito control
Traditional and commonly used chemical insecticide will be applied to reduce the mosquito population
Active Comparator: Control sites with traditional mosquito control only
Traditional mosquito control will be applied but no mosquito release will occur in the control sites

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Epidemiological impact of combined IIT-SIT
Time Frame: Up to 19 months
Incidence of symptomatic Aedes-borne virus (dengue, chikungunya, Zika) confirmed by laboratory testing by the Yucatan Ministry of Health.
Up to 19 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Entomological impact of combined IIT-SIT
Time Frame: Up to 19 months
Number of Aedes aegypti females infected with dengue, chikungunya or Zika virus (quantified as minimum infection rate, MIR); Number of Aedes aegypti females collected indoors (during 10-minute collections) using Prokopack aspirators; Number of Aedes aegypti females collected in the peridomicile with BG-sentinel traps.
Up to 19 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Michigan State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Emory University
Universidad Autónoma de Yucatán

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Gonzalo Vazquez Professor Prokopec, PhD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00010509
  • 7200AA23FA00021 (Other Identifier: USAID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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