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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 : July 2, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Mexican Society of Public Health

Brief Summary:
Background: Dengue continues to be a high priority disease for public health in tropical and subtropical countries, where vector control measures have not had the expected impact on transmission. The development of new vaccines opens the possibility of having an additional measure capable of preventing the development of the disease and avoiding its complications. Currently, in two of the Dengue virus (DENV) vaccines a differential behaviour of the immune response has been observed between seropositive and seronegative individuals, which makes the generation of evidence from prevalence studies in places of high and low endemicity more relevant. Objective: To determine the predominant type of humoral immune response in high areas and to estimate the serotype-specific prevalence for DENV in people groups aged 5 to 35 years living in Mexican cities with low and high dengue endemicity. Methodology: Descriptive cross-sectional study with subgroup analysis (by endemic and non-endemic areas, by age groups and by sex). Expected results: In areas of low dengue endemicity the humoral immune response against dengue is predominantly monotypic (against one serotype) while in areas of high dengue endemicity it is predominantly multitype (against two or more serotypes).

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1960 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
  • Estimate the specific serotype prevalence for DENGUE Virus in groups from 5 to 35 years old in areas of low and high dengue endemicity.
  • Determine the general prevalence of antibodies (IgG) against DENGUE Virus in groups aged 5 to 35 years in areas of high and low incidence of dengue.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Serological Study of Dengue and Characterization of Immune Response in Ten Endemic and Non-Endemic Cities in Mexico
Estimated Study Start Date : July 30, 2021
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arm Intervention/treatment
Serological survey
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)

Other Names:
  • Indirect IgG ELISA to estimate seroprevalence
  • PRNT to describe Serotype-specific neutralizing antibody titer




Primary Outcome Measures :
  1. Percentage of participants with Dengue IgG antibodies [ Time Frame: four months ]
    Using ELISA for IgG-Indirect, results might be positive, negative or undetermined

  2. 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.

  3. 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
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • Diseases that prevent consent from themselves.
  • Insufficient blood sample volume to perform laboratory tests.

Information from the National Library of Medicine

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


Contacts
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Contact: Jesús Felipe Gonzalez-Roldan, MD 525552034592 ext 107 jesusfgonzalez@smsp.org.mx
Contact: SONIA Lopez-Alvarez, MsC 525532001396 sonia.lopez.alvarez@hotmail.com

Locations
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Mexico
Mexican Society of Public Health
Mexico city, Mexico, 11590
Contact: Jesus Felipe Gonzalez Roldan, MD    52 (55) 5203 4592 ext 107    jesusfgonzalez@smsp.org.mx   
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         
Sponsors and Collaborators
Mexican Society of Public Health
Merck Sharp & Dohme Corp.
Publications:
Organización Panamericana de la Salud. Dengue 2021 available at http://www.openepi.com/Menu/OE_Menu.htm
Secretaria de Salud. Lineamientos para la vigilancia por laboratorio del dengue y otros arbovirus 2021. available at https://www.gob.mx/salud/documentos/lineamiento-estandarizado-para-la-vigilancia-epidemiologica-y-por-laboratorio-de-enfermedad-por-2019-ncov
Centros para el Control y la Prevención de Enfermedades. Pruebas serológicas del virus del dengue 2020 [Available from: https://www.cdc.gov/dengue/es/healthcare-providers/testing/serologic-tests.html.
Organización Mundial de la Salud. Vacuna contra el dengue. Documento de posicion. Boletin Epidemiológico semanal 2018 36:457-76. available at https://www.who.int/immunization/policy/position_papers/PP_dengue_2018_SP.pdf?ua=1
World Health Organization. WHO Vaccine pipeline tracker 2020 [01/05/2021]. Available from: ttps://www.who.int/immunization/research/vaccine_pipeline_tracker_spreadsheet/en/.

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Responsible Party: Mexican Society of Public Health
ClinicalTrials.gov Identifier: NCT04947111    
Other Study ID Numbers: 1
First Posted: July 1, 2021    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mexican Society of Public Health:
Dengue Vaccines
Serologic Test
Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs