DengueNCT06595745
Testing Combined IIT-SIT to Control Mosquito-Borne Diseases At Scale
A study testing Wolbachia induced incompatible mating in people with Dengue and Zika, run by Michigan State University at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dengue, Zika, Chikungunya
- What is being tested?
- Wolbachia induced incompatible mating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,243 participants
- Where
- 1 siteMexico
- Study dates
- 28 May 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All residents in the release sites will be included in the studies
Who cannot join
- No exclusion will be performed.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Laboratorio para el Control Biolo´gico de Aedes aegypti (LCB-UADY), Universidad Autónoma de Yucatán
Mérida, Yucatán, 97160
About this study
Official title: 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.
- Conditions
- Dengue, Zika, Chikungunya
- Being tested
- Wolbachia induced incompatible mating, Standard traditional chemical mosquito control
- Keywords
- Wolbachia, IIT, SIT, Aedes aegypti, Dengue, Zika, Chikungunya
- Medical subject headings
- Dengue, Zika Virus Infection, Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wolbachia induced incompatible matingGenetic
Also called Incompatible insect technique, Sterile insect technique
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.
Standard traditional chemical mosquito controlCombination product
Traditional and commonly used chemical insecticide will be applied to reduce the mosquito population
| Study group | Role | What they receive |
|---|---|---|
| Release sites | Experimental | 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. Receives: Genetic: Wolbachia induced incompatible mating; Combination Product: Standard traditional chemical mosquito control |
| Control sites with traditional mosquito control only | Active comparator | Traditional mosquito control will be applied but no mosquito release will occur in the control sites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiological impact of combined IIT-SIT
Incidence of symptomatic Aedes-borne virus (dengue, chikungunya, Zika) confirmed by laboratory testing by the Yucatan Ministry of Health.
Measured: Up to 19 months
Secondary outcomes (1)
Entomological impact of combined IIT-SIT
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.
Measured: Up to 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start28 May 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Why it stopped: The USAID fund sponsoring this trial was terminated in February 2025.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DengueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15,243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autónoma de Yucatán, Emory University
- Responsible party
- Principal investigator, Zhiyong Xi, Michigan State University
- Investigators
- Gonzalo Vazquez Professor Prokopec, PhD, Study chair, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595745
- Sponsor's protocol ID
- STUDY00010509
- Other IDs
- 7200AA23FA00021
- Status last verified
- Mar 2026
- First submitted
- 9 Sep 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liang X, Tan CH, Sun Q, Zhang M, Wong PSJ, Li MI, Mak KW, Martin-Park A, Contreras-Perera Y, Puerta-Guardo H, Manrique-Saide P, Ng LC, Xi Z. Wolbachia wAlbB remains stable in Aedes aegypti over 15 years but exhibits genetic background-dependent variation in virus blocking. PNAS Nexus. 2022 Sep 22;1(4):pgac203. doi: 10.1093/pnasnexus/pgac203. eCollection 2022 Sep.
PubMed 36714832Lim JT, Bansal S, Chong CS, Dickens B, Ng Y, Deng L, Lee C, Tan LY, Chain G, Ma P, Sim S, Tan CH, Cook AR, Ng LC. Efficacy of Wolbachia-mediated sterility to reduce the incidence of dengue: a synthetic control study in Singapore. Lancet Microbe. 2024 May;5(5):e422-e432. doi: 10.1016/S2666-5247(23)00397-X. Epub 2024 Feb 8.
PubMed 38342109Martin-Park A, Che-Mendoza A, Contreras-Perera Y, Perez-Carrillo S, Puerta-Guardo H, Villegas-Chim J, Guillermo-May G, Medina-Barreiro A, Delfin-Gonzalez H, Mendez-Vales R, Vazquez-Narvaez S, Palacio-Vargas J, Correa-Morales F, Ayora-Talavera G, Pavia-Ruz N, Liang X, Fu P, Zhang D, Wang X, Toledo-Romani ME, Xi Z, Vazquez-Prokopec G, Manrique-Saide P. Pilot trial using mass field-releases of sterile males produced with the incompatible and sterile insect techniques as part of integrated Aedes aegypti control in Mexico. PLoS Negl Trop Dis. 2022 Apr 26;16(4):e0010324. doi: 10.1371/journal.pntd.0010324. eCollection 2022 Apr.
PubMed 35471983Zheng X, Zhang D, Li Y, Yang C, Wu Y, Liang X, Liang Y, Pan X, Hu L, Sun Q, Wang X, Wei Y, Zhu J, Qian W, Yan Z, Parker AG, Gilles JRL, Bourtzis K, Bouyer J, Tang M, Zheng B, Yu J, Liu J, Zhuang J, Hu Z, Zhang M, Gong JT, Hong XY, Zhang Z, Lin L, Liu Q, Hu Z, Wu Z, Baton LA, Hoffmann AA, Xi Z. Incompatible and sterile insect techniques combined eliminate mosquitoes. Nature. 2019 Aug;572(7767):56-61. doi: 10.1038/s41586-019-1407-9. Epub 2019 Jul 17.
PubMed 31316207
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Combined Approach to Control Mosquito-Borne Diseases at Scale
- ClinicalTrials.gov ID
- NCT06595745
- Acronym / sponsor ID
- STUDY00010509
- Conditions
- Dengue, Zika, Chikungunya
- Keywords
- Wolbachia, IIT, SIT, Aedes aegypti, Dengue, Zika, Chikungunya
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The USAID fund sponsoring this trial was terminated in February 2025.
- Enrolment
- 15,243 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Universidad Autónoma de Yucatán, Emory University
- Study start
- 28 May 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Release sites | Experimental | Genetic: Wolbachia induced incompatible mating, Combination Product: Standard traditional chemical mosquito controlTraditional mosquito control will be applied, followed by weekly release of Wolbachia wAlbB-infected Aedes aegypti males to induce sterile mating with wild female mosquitoes. |
| Control sites with traditional mosquito control only | Active comparator | –Traditional mosquito control will be applied but no mosquito release will occur in the control sites |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All residents in the release sites will be included in the studies
Key exclusion criteria (1 listed)
- No exclusion will be performed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wolbachia induced incompatible matingAlso: Incompatible insect technique, Sterile insect techniqueThe 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. | Genetic | Release sites |
| Standard traditional chemical mosquito controlTraditional and commonly used chemical insecticide will be applied to reduce the mosquito population | Combination product | Release sites |
Primary outcome
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.
1 secondary outcome
Entomological impact of combined IIT-SIT
Time frame: Up to 19 months
Results and safety
The study was stopped early (reason given: The USAID fund sponsoring this trial was terminated in February 2025.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 36714832Liang X, Tan CH, Sun Q, Zhang M, Wong PSJ, Li MI, Mak KW, Martin-Park A, Contreras-Perera Y, Puerta-Guardo H, Manrique-Saide P, Ng LC, Xi Z. Wolbachia wAlbB remains stable in Aedes aegypti over 15 years but exhibits genetic background-dependent variation in virus blocking. PNAS Nexus. 2022 Sep 22;1(4):pgac203. doi: 10.1093/pnasnexus/pgac203. eCollection 2022 Sep.
- Background: PubMed 38342109Lim JT, Bansal S, Chong CS, Dickens B, Ng Y, Deng L, Lee C, Tan LY, Chain G, Ma P, Sim S, Tan CH, Cook AR, Ng LC. Efficacy of Wolbachia-mediated sterility to reduce the incidence of dengue: a synthetic control study in Singapore. Lancet Microbe. 2024 May;5(5):e422-e432. doi: 10.1016/S2666-5247(23)00397-X. Epub 2024 Feb 8.
- Background: PubMed 35471983Martin-Park A, Che-Mendoza A, Contreras-Perera Y, Perez-Carrillo S, Puerta-Guardo H, Villegas-Chim J, Guillermo-May G, Medina-Barreiro A, Delfin-Gonzalez H, Mendez-Vales R, Vazquez-Narvaez S, Palacio-Vargas J, Correa-Morales F, Ayora-Talavera G, Pavia-Ruz N, Liang X, Fu P, Zhang D, Wang X, Toledo-Romani ME, Xi Z, Vazquez-Prokopec G, Manrique-Saide P. Pilot trial using mass field-releases of sterile males produced with the incompatible and sterile insect techniques as part of integrated Aedes aegypti control in Mexico. PLoS Negl Trop Dis. 2022 Apr 26;16(4):e0010324. doi: 10.1371/journal.pntd.0010324. eCollection 2022 Apr.
- Background: PubMed 31316207Zheng X, Zhang D, Li Y, Yang C, Wu Y, Liang X, Liang Y, Pan X, Hu L, Sun Q, Wang X, Wei Y, Zhu J, Qian W, Yan Z, Parker AG, Gilles JRL, Bourtzis K, Bouyer J, Tang M, Zheng B, Yu J, Liu J, Zhuang J, Hu Z, Zhang M, Gong JT, Hong XY, Zhang Z, Lin L, Liu Q, Hu Z, Wu Z, Baton LA, Hoffmann AA, Xi Z. Incompatible and sterile insect techniques combined eliminate mosquitoes. Nature. 2019 Aug;572(7767):56-61. doi: 10.1038/s41586-019-1407-9. Epub 2019 Jul 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gonzalo Vazquez Professor Prokopec, PhD study chair
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wolbachia induced incompatible mating in people with Dengue and Zika, run by Michigan State University at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The USAID fund sponsoring this trial was terminated in February 2025.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiological impact of combined IIT-SIT (time frame: Up to 19 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06595745, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.