Serological Study of Dengue and Characterization of Immune Response in Ten Endemic and Non-Endemic Cities in Mexico

NCT04947111 | Unknown DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: 1,960
• Locations: 1 country
• Sites: 1

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).

Conditions

Dengue

Keywords

Dengue Vaccines; Serologic Test

Outcome Measures

Primary Outcomes (3)

• Percentage of participants with Dengue IgG antibodies

  Using ELISA for IgG-Indirect, results might be positive, negative or undetermined

  four months

• Ratio of neutralizing antibodies against DENV1, DENV2, DENV3 and/or DENV4

  Using PRNT, values might be 1:20, 1:40, 1:80, 1:160, 1:320 and 1:640.

  Six months

• Percentage of participants with monotypic and multitypic response

  Monotypic: antibodies against one serotype Multitypic: antibodies against more than one serotype

  eight months

Study Arms (1)

Serological survey

OTHER

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

Interventions

Estimate the distribution of antibodies by serotype by Dengue virus in areas of low and high incidence of dengue DIAGNOSTIC_TEST

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)

Also known as: Indirect IgG ELISA to estimate seroprevalence, PRNT to describe Serotype-specific neutralizing antibody titer

Serological survey

Eligibility Criteria

• Age: 5 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mexican Society of Public Health: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Mexican Society of Public Health

Mexico City, 11590, Mexico

Location

Related Publications (20)

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  BACKGROUND

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MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Central Study Contacts

Jesús Felipe Gonzalez-Roldan, MD

CONTACT

525552034592; jesusfgonzalez@smsp.org.mx

SONIA Lopez-Alvarez, MsC

CONTACT

525532001396; sonia.lopez.alvarez@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * 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.

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: July 1, 2021
• Study Start: April 30, 2022
• Primary Completion: July 30, 2022
• Study Completion: September 30, 2022
• Last Updated: March 4, 2022

Record last verified: 2022-03

Locations

ME (1)