Testing Combined IIT-SIT to Control Mosquito-Borne Diseases At Scale
NCT06595745 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15243
Last updated 2026-03-19
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. 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
Interventions
- 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.
- COMBINATION_PRODUCT
-
Standard traditional chemical mosquito control
Traditional and commonly used chemical insecticide will be applied to reduce the mosquito population
Sponsors & Collaborators
-
Universidad Autónoma de Yucatán
collaborator OTHER -
Emory University
collaborator OTHER - lead OTHER
Principal Investigators
-
Gonzalo Vazquez Professor Prokopec, PhD · Emory University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-05-28
- Primary Completion
- 2025-01-31
- Completion
- 2025-01-31
Countries
- Mexico
Study Locations
More Related Trials
-
Evaluating the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito Control Vaccine
NCT04009824 ·Status: COMPLETED ·Phase: PHASE1
-
Field Evaluations of Innovative Tools for Vector-borne Disease Control in Conflict-affected Communities
NCT06179732 ·Status: COMPLETED ·Phase: PHASE3
-
Thermotherapy + a Short Course of Miltefosine for the Treatment of Uncomplicated Cutaneous Leishmaniasis in the New World¨
NCT02687971 ·Status: COMPLETED ·Phase: PHASE2
-
Coadministration of GA2 Sporozoites With Adjuvants
NCT05468606 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
Applying Wolbachia to Eliminate Dengue
NCT03055585 ·Status: TERMINATED ·Phase: NA
-
Clinical Study to Assess Minimum Mosquito Bites for P. Vivax Infection in Thai Adults
NCT07257965 ·Status: RECRUITING ·Phase: NA
-
Safety of and Immune Response to a Malaria Vaccine (MSP1 42-C1) With or Without CPG 7909 Adjuvant
NCT00320658 ·Status: COMPLETED ·Phase: PHASE1
-
Preventing the Spread of Malaria in Mali
NCT01360112 ·Status: COMPLETED
-
Phase I Study of AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909 Malaria Vaccine
NCT00427167 ·Status: COMPLETED ·Phase: PHASE1
-
The Evaluation of Potential Zika, Chikungunya, and Dengue Infections in Mexico
NCT02831699 ·Status: COMPLETED
-
Safety, Immunogenicity and Efficacy Against of a Combined Malaria Vaccine in Healthy Malaria-naïve Adults
NCT01366534 ·Status: COMPLETED ·Phase: PHASE2
-
EaveTubes for Vector Control
NCT05736679 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Phase 1 Study of the Safety and Immunogenicity of a Malaria Transmission-blocking Pfs25-Pfs25 Conjugate Vaccine
NCT00977899 ·Status: WITHDRAWN ·Phase: PHASE1
-
Assessing Human-to-Mosquito Transmission in Volunteers Participating in Malaria Vaccine Candidate Trials in Mali
NCT02206451 ·Status: COMPLETED
-
World Mosquito Program Noumea - Human Sample Component
NCT03552094 ·Status: UNKNOWN
-
Sylvatic Transmission of Zika, Dengue, and Chikungunya Viruses in Thailand and Cambodia
NCT04434846 ·Status: COMPLETED
-
Defining Skin Immunity of a Bite of Key Insect Vectors in Humans
NCT03641339 ·Status: COMPLETED ·Phase: NA
-
Investigating Vector-Borne Determinants of Aedes Transmitted Arboviral Infections in Cambodia: An Observational Longitudinal Cohort Study in Children
NCT03534245 ·Status: COMPLETED
-
Immunization With Plasmodium Falciparum Sporozoites Under Chloroquine Versus Mefloquine Prophylaxis
NCT01422954 ·Status: COMPLETED ·Phase: NA
-
Enhancing Protection Against Vector-borne Diseases in Forcibly Displaced Communities: Evaluating the Efficacy of Spatial Repellents for Cutaneous Leishmaniasis Control in North-East Syria
NCT06917040 ·Status: COMPLETED ·Phase: PHASE3
-
Experimental Malaria Infection of Healthy Malaria-Naive Adults by Mosquito Bite With the Genetically Modified Plasmodium Falciparum NF54/iGP3 GAP
NCT06881732 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Impact of Project Wolbachia - Singapore on Dengue Incidence
NCT05505682 ·Status: COMPLETED ·Phase: NA
-
Implementation Research of New Dengue Vector Control Tools
NCT00883441 ·Status: COMPLETED ·Phase: NA
-
Malaria Vaccine for Children in Mali
NCT00740090 ·Status: COMPLETED ·Phase: PHASE1
-
Target Antigens Induced by Plasmodium Falciparum Sporozoite Immunization Under Chemoprophylaxis
NCT02080026 ·Status: COMPLETED ·Phase: NA