Serological Study of Dengue and Characterization of Immune Response in Ten Endemic and Non-Endemic Cities in Mexico
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|ClinicalTrials.gov Identifier: NCT04947111|
Recruitment Status : Not yet recruiting
First Posted : July 1, 2021
Last Update Posted : March 4, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Dengue||Diagnostic Test: Estimate the distribution of antibodies by serotype by Dengue virus in areas of low and high incidence of dengue||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1960 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
|Masking:||None (Open Label)|
|Official Title:||Serological Study of Dengue and Characterization of Immune Response in Ten Endemic and Non-Endemic Cities in Mexico|
|Estimated Study Start Date :||April 30, 2022|
|Estimated Primary Completion Date :||July 30, 2022|
|Estimated Study Completion Date :||September 30, 2022|
A blood sample will be taken to estimate the specific serotype prevalence for dengue virus in groups of 5 to 35 years in areas of low and high dengue endemicity.
Diagnostic Test: Estimate the distribution of antibodies by serotype by Dengue virus in areas of low and high incidence of dengue
Indirect IgG ELISA to estimate seroprevalence: The seropositivity will be evaluated with the Indirect IgG ELISA following the instructions of the Panbio E-DEN 01 G manufacturer, which has a specificity of 98% and a sensitivity of 100%. In brief, 10 microliters of participant serum will be used for each assay. Each kit provides a positive and negative control, as well as three calibrators, with the respective values for quality control. Samples will be classified as positive, negative or indeterminate according to the cut-off point for each ELISA kit.
Neutralizing antibody titers serotype-specific: To establish the type of humoral immunity that the selected city presents, the measurement of the neutralizing antibody titers will be carried out by means of the neutralization test by reducing the number of lytic plaques to 50% (PRNT50%) , using Vero cells and the following reference strains for each serotype: DENV-1 (HAWAI), DENV-2 (NEW GUINEA), DENV-3 (H-887) and DENV-4 (H-24)
- Percentage of participants with Dengue IgG antibodies [ Time Frame: four months ]Using ELISA for IgG-Indirect, results might be positive, negative or undetermined
- Ratio of neutralizing antibodies against DENV1, DENV2, DENV3 and/or DENV4 [ Time Frame: Six months ]Using PRNT, values might be 1:20, 1:40, 1:80, 1:160, 1:320 and 1:640.
- Percentage of participants with monotypic and multitypic response [ Time Frame: eight months ]Monotypic: antibodies against one serotype Multitypic: antibodies against more than one serotype
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|Ages Eligible for Study:||5 Years to 35 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Subjects from 5 years to 35 years who live in the selected localities.
- Informed consent for adults or for the parents of minors who participate in the study.
- Informed assent for children and adolescents between 7 years and 17 years.
- Diseases that prevent consent from themselves.
- Insufficient blood sample volume to perform laboratory tests.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04947111
|Contact: Jesús Felipe Gonzalez-Roldan, MD||525552034592 ext email@example.com|
|Contact: SONIA Lopez-Alvarez, MsCfirstname.lastname@example.org|
|Mexican Society of Public Health|
|Mexico city, Mexico, 11590|
|Contact: Jesus Felipe Gonzalez Roldan, MD 52 (55) 5203 4592 ext 110 email@example.com|
|Principal Investigator: Jesus Felipe Gonzalez Roldan, MD|
|Sub-Investigator: Jose Ramos Castañeda, PhD|
|Sub-Investigator: Yvonne Amaya-Larios, PhD|
|Sub-Investigator: Ruth Martínez-Vega, PhD|
|Sub-Investigator: Sonia López Alvarez, MSc|
|Sub-Investigator: Lorena Suarez-Idueta, MSc|
|Responsible Party:||Mexican Society of Public Health|
|Other Study ID Numbers:||
|First Posted:||July 1, 2021 Key Record Dates|
|Last Update Posted:||March 4, 2022|
|Last Verified:||March 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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