EVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil
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| Publication Date: | 2022 |
| Other Authors: | , , , , , , , , , , , , , , , , |
| Format: | Article |
| Language: | eng |
| Source: | Repositório Institucional da FIOCRUZ (ARCA) |
| Download full: | https://www.arca.fiocruz.br/handle/icict/56082 |
Summary: | Department of Medicine. Division of Infectious Diseases. The Hope Clinic of the Emory Vaccine Center. Emory University, Atlanta, GA, USA. |
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Collins, Matthew HPotter, Gail EHitchings, Matt D TButler, EllieWiles, MichelleKennedy, Jessie KPinto, Sofia BTeixeira, Adla B MCasanovas-Massana, ArnauRouphael, Nadine GDeye, Gregory ASimmons, Cameron PMoreira, Luciano AndradeNogueira, Mauricio LCummings, Derek A TKo, Albert Ieixeira, Mauro M TEdupuganti, Srilatha2022-12-20T13:11:46Z2022-12-20T13:11:46Z2022COLLINS, Matthew H et al. EVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil. Trials, v. 23, n. 1, 185, 2022. doi: 10.1186/s13063-022-05997-4.1745-6215https://www.arca.fiocruz.br/handle/icict/56082engBioMed CentralEVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazilinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleDepartment of Medicine. Division of Infectious Diseases. The Hope Clinic of the Emory Vaccine Center. Emory University, Atlanta, GA, USA.Biostatistics Research Branch. National Institute of Allergy and Infectious Diseases. National Institutes of Health. Rockville, MD, USA/The Emmes Company. LLC. Rockville, USA.Emerging Pathogens Institute and Department of Biology. University of Florida. Gainesville, FL, USA.Department of Medicine. Division of Infectious Diseases. The Hope Clinic of the Emory Vaccine Center. Emory University, Atlanta, GA, USA.Department of Medicine. Division of Infectious Diseases. The Hope Clinic of the Emory Vaccine Center. Emory University, Atlanta, GA, USA.The Emmes Company. LLC. Rockville, USA.World Mosquito Program. Monash University. Melbourne, Australia.School of Education. Universidade Federal de Minas Gerais. Belo Horizonte, MG, Brazil.Department of Epidemiology of Microbial Diseases. Yale School of Public Health. New Haven, CT, USA.Department of Medicine. Division of Infectious Diseases. The Hope Clinic of the Emory Vaccine Center. Emory University, Atlanta, GA, USA.Division of Microbiology and Infectious Diseases. National Institute of Allergy and Infectious Diseases. Bethesda, MD, USA.World Mosquito Program. Monash University. Melbourne, Australia.Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brazil.Medical School of São Jose do Rio Preto. São Jose do Rio Preto, SP, Brazil.Emerging Pathogens Institute and Department of Biology. University of Florida. Gainesville, FL, USA.Department of Epidemiology of Microbial Diseases. Yale School of Public Health. New Haven, CT, USA/Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brazil.Department of Biochemistry and Immunology. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil.Department of Medicine. Division of Infectious Diseases. The Hope Clinic of the Emory Vaccine Center. Emory University. Atlanta, GA, USABackground: Arboviruses transmitted by Aedes aegypti including dengue, Zika, and chikungunya are a major global health problem, with over 2.5 billion at risk for dengue alone. There are no licensed antivirals for these infections, and safe and effective vaccines are not yet widely available. Thus, prevention of arbovirus transmission by vector modification is a novel approach being pursued by multiple researchers. However, the field needs high-quality evidence derived from randomized, controlled trials upon which to base the implementation and maintenance of vector control programs. Here, we report the EVITA Dengue trial design (DMID 17-0111), which assesses the efficacy in decreasing arbovirus transmission of an innovative approach developed by the World Mosquito Program for vector modification of Aedes mosquitoes by Wolbachia pipientis. Methods: DMID 17-0111 is a cluster-randomized trial in Belo Horizonte, Brazil, with clusters defined by primary school catchment areas. Clusters (n = 58) will be randomized 1:1 to intervention (release of Wolbachia-infected Aedes aegypti mosquitoes) vs. control (no release). Standard vector control activities (i.e., insecticides and education campaigns for reduction of mosquito breeding sites) will continue as per current practice in the municipality. Participants (n = 3480, 60 per cluster) are children aged 6-11 years enrolled in the cluster-defining school and living within the cluster boundaries who will undergo annual serologic surveillance for arboviral infection. The primary objective is to compare sero-incidence of arboviral infection between arms. Discussion: DMID 17-0111 aims to determine the efficacy of Wolbachia-infected mosquito releases in reducing human infections by arboviruses transmitted by Aedes aegypti and will complement the mounting evidence for this method from large-scale field releases and ongoing trials. The trial also represents a critical step towards robustness and rigor for how vector control methods are assessed, including the simultaneous measurement and correlation of entomologic and epidemiologic outcomes. Data from this trial will inform further the development of novel vector control methods. Trial registration: ClinicalTrials.gov NCT04514107 . Registered on 17 August 2020 Primary sponsor: National Institute of Health, National Institute of Allergy and Infectious Diseases.ArbovirusChikungunyaClinical trialCluster-randomized controlled trialDenguePreventionVector controlVector-borne diseaseWolbachiaZikainfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/56082/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALEVITA Dengue.pdfEVITA Dengue.pdfapplication/pdf2143727https://www.arca.fiocruz.br/bitstream/icict/56082/2/EVITA%20Dengue.pdf7879d937a96606c8533e3005718bc166MD52icict/560822022-12-20 10:11:46.974oai:www.arca.fiocruz.br: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ório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352022-12-20T13:11:46Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false |
| dc.title.en_US.fl_str_mv |
EVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil |
| title |
EVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil |
| spellingShingle |
EVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil Collins, Matthew H Arbovirus Chikungunya Clinical trial Cluster-randomized controlled trial Dengue Prevention Vector control Vector-borne disease Wolbachia Zika |
| title_short |
EVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil |
| title_full |
EVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil |
| title_fullStr |
EVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil |
| title_full_unstemmed |
EVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil |
| title_sort |
EVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil |
| author |
Collins, Matthew H |
| author_facet |
Collins, Matthew H Potter, Gail E Hitchings, Matt D T Butler, Ellie Wiles, Michelle Kennedy, Jessie K Pinto, Sofia B Teixeira, Adla B M Casanovas-Massana, Arnau Rouphael, Nadine G Deye, Gregory A Simmons, Cameron P Moreira, Luciano Andrade Nogueira, Mauricio L Cummings, Derek A T Ko, Albert I eixeira, Mauro M T Edupuganti, Srilatha |
| author_role |
author |
| author2 |
Potter, Gail E Hitchings, Matt D T Butler, Ellie Wiles, Michelle Kennedy, Jessie K Pinto, Sofia B Teixeira, Adla B M Casanovas-Massana, Arnau Rouphael, Nadine G Deye, Gregory A Simmons, Cameron P Moreira, Luciano Andrade Nogueira, Mauricio L Cummings, Derek A T Ko, Albert I eixeira, Mauro M T Edupuganti, Srilatha |
| author2_role |
author author author author author author author author author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
Collins, Matthew H Potter, Gail E Hitchings, Matt D T Butler, Ellie Wiles, Michelle Kennedy, Jessie K Pinto, Sofia B Teixeira, Adla B M Casanovas-Massana, Arnau Rouphael, Nadine G Deye, Gregory A Simmons, Cameron P Moreira, Luciano Andrade Nogueira, Mauricio L Cummings, Derek A T Ko, Albert I eixeira, Mauro M T Edupuganti, Srilatha |
| dc.subject.en.en_US.fl_str_mv |
Arbovirus Chikungunya Clinical trial Cluster-randomized controlled trial Dengue Prevention Vector control Vector-borne disease Wolbachia Zika |
| topic |
Arbovirus Chikungunya Clinical trial Cluster-randomized controlled trial Dengue Prevention Vector control Vector-borne disease Wolbachia Zika |
| description |
Department of Medicine. Division of Infectious Diseases. The Hope Clinic of the Emory Vaccine Center. Emory University, Atlanta, GA, USA. |
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2022 |
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2022-12-20T13:11:46Z |
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2022-12-20T13:11:46Z |
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2022 |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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article |
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COLLINS, Matthew H et al. EVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil. Trials, v. 23, n. 1, 185, 2022. doi: 10.1186/s13063-022-05997-4. |
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https://www.arca.fiocruz.br/handle/icict/56082 |
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1745-6215 |
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COLLINS, Matthew H et al. EVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil. Trials, v. 23, n. 1, 185, 2022. doi: 10.1186/s13063-022-05997-4. 1745-6215 |
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BioMed Central |
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BioMed Central |
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