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

NCT04947111 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1960

Last updated 2022-03-04

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2022-07-30
Completion
2022-09-30

Countries

  • Mexico

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04947111 on ClinicalTrials.gov