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A Dengue Sero-prevalence Study in the Metropolitan Area of Buenos Aires

A Dengue Sero-prevalence Study in the Metropolitan Area of Buenos Aires

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05919277
Enrollment
1487
Registered
2023-06-26
Start date
2023-09-11
Completion date
2024-09-30
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dengue, Flavivirus Infections

Brief summary

The objective of this observational study of dengue seroprevalence in the metropolitan area of Buenos Aires is to know what percentage of the population has antibodies against dengue in persons 18 years of age or older who are residents of the city of Buenos Aires or its metropolitan area. The main questions to be answered are: * What is the seroprevalence of antibodies against dengue measured by Immunoglobulin G determination by ELISA * Characterize the different dengue serotypes in the affected population. Participants will undergo a small blood draw to determine the presence of Immunoglobulin G antibodies against dengue. * Tests will also be performed to determine infection by flaviviruses other than dengue virus.

Detailed description

A two-stage stratified design will be used. The primary sampling units will be mostly defined as the census sections of the 2010 National Census of Population, Households and Dwellings. It has 5 strata, constructed through a functional relationship between the income quintiles obtained in the Annual Household Survey (AHS) and the variables that were surveyed in the census. Stratum 1 corresponds to the lowest income population, while stratum 5 corresponds to the highest. The first stage of sampling in this framework will consist of about 100 to 300 primary sampling units, called primary units areas, selected with a probability proportional to size, the measure of size being the total number of dwellings. A sample of 1,487 dwellings is proposed. In each primary unit area, a number of dwellings will be selected to be visited by enumerators, who will make a list of all members residing in the dwelling (regardless of whether they are from the same household) and select a member aged ≥18 years to proceed with the survey. This last selection is a 3rd and final sampling stage that will define the sample of 1487 participants to be tested. The sample size was calculated based on the estimated probability of pre-infection for each of the municipalities and localities participating in the survey.

Interventions

DIAGNOSTIC_TESTDengue Immunoglobulin G antibodies performed with ELISA

All participants who agree to participate by signing an informed consent form will undergo a finger prick for the determination of Immunoglobulin G antibodies measured by ELISA. In a subgroup of persons who test positive, they will be invited to have blood drawn for neutralization determination in order to study serotypes and the presence of other flaviviruses.

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Fundacion GESICA
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* \- Age ≥18 at the time of signing the informed consent. * \- Resident of the Buenos Aires metropolitan area

Exclusion criteria

* To be ≤17 years old. * Inability to give informed consent.

Design outcomes

Primary

MeasureTime frameDescription
SeroprevalenceThrough study completion, an average of 1 yearPercentage of the population with Immunoglobulin G antibodies against dengue fever

Secondary

MeasureTime frameDescription
Other flavivirus prevalenceThrough study completion, an average of 1 yearPercentage of population with Immunoglobulin G antibodies to dengue, but found to be cross-reactive to other flaviviruses on plaque neutralization.
Specific dengue serotypeThrough study completion, an average of 1 yearDengue-specific serotype among the Immunoglobulin G-positive population.

Countries

Argentina

Contacts

Primary ContactCristian Biscayart, MD
cristianbiscayart@gmail.com541145204002
Backup ContactPatricia Angeleri, MD
pangeleri@intramed.net541145204002

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026