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Sero-epidemiology of Priority Arboviruses in French Guiana (EPI-ARBO)

Primary Purpose

Arbovirus Infections

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Human Biological samples
Sponsored by
Institut Pasteur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Arbovirus Infections

Eligibility Criteria

2 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Guiana resident for at least 6 months and present during the entire study period
  • Age between 2 and 75 years old

Exclusion Criteria:

  • Subject under guardianship or deprived of liberty by judicial decision
  • Subject with any pathology or health problem not compatible with blood sampling

Sites / Locations

  • Institut Pasteur de la Guyane

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Guiana population

Arm Description

Human Biological samples from Guiana population : Two serum tubes of blood will be collected

Outcomes

Primary Outcome Measures

Dengue, chikungunya, zika Antibodies detection by multiplex serologic tests
Description of the virological status of individuals by Mutiplex detection of antibodies directed against dengue, chikungunya and zika arboviruses.

Secondary Outcome Measures

Seroprevalence by area and age
Estimatation of the frequency of Dengue, Chikungunya and zika infections among the general population of French Guiana by geographical area and by age class

Full Information

First Posted
June 16, 2017
Last Updated
September 11, 2020
Sponsor
Institut Pasteur
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1. Study Identification

Unique Protocol Identification Number
NCT03210363
Brief Title
Sero-epidemiology of Priority Arboviruses in French Guiana
Acronym
EPI-ARBO
Official Title
Sero-epidemiology of Priority Arboviruses in French Guiana
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 9, 2017 (Actual)
Primary Completion Date
November 21, 2017 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Pasteur

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Dengue is an important public health problem despite the efforts of local health authorities to mitigate the impact of epidemics and the epidemiology of dengue evolved from an endemo-epidemic to a hyper-endemic state. In late 2013, the first local transmission of chikungunya virus in the Americas was identified in Caribbean countries and territories including French Guiana. Rapidly, more than 16,000 suspected local Health authorities had reported cases. In May 2015, the Pan American Health Organization (PAHO) issued an alert regarding the first confirmed Zika virus infections in Brazil. The emergence of Zika virus in South America led to a rapid spread throughout South and Central America, reaching French Guiana in December 2015. With the increasing frequency of epidemics related to arbovirus and the resulting health, social, and economic impacts of dengue, the surveillance of arbovirus have become social, political, and public health challenges that require specific and non-available immune status information.
Detailed Description
French Guiana is a 250,000 inhabitant's French overseas department located in South America, the epidemiology of arboviruses has recently evolved and marked by important outbreaks. Dengue remains an important public health problem despite the efforts of local health authorities to mitigate the impact of epidemics and the epidemiology of dengue evolved from an endemo-epidemic to a hyper-endemic state. In late 2013, the first local transmission of chikungunya virus in the Americas was identified in Caribbean countries and territories including French Guiana. Rapidly, more than 16,000 suspected local Health authorities had reported cases. In May 2015, the Pan American Health Organization (PAHO) issued an alert regarding the first confirmed Zika virus infections in Brazil. The emergence of Zika virus in South America led to a rapid spread throughout South and Central America, reaching French Guiana in December 2015. With the increasing frequency of epidemics related to arbovirus and the resulting health, social, and economic impacts of dengue, the surveillance of arbovirus have become social, political, and public health challenges that require specific and non-available immune status information.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arbovirus Infections

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2697 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guiana population
Arm Type
Experimental
Arm Description
Human Biological samples from Guiana population : Two serum tubes of blood will be collected
Intervention Type
Other
Intervention Name(s)
Human Biological samples
Intervention Description
Blood sample
Primary Outcome Measure Information:
Title
Dengue, chikungunya, zika Antibodies detection by multiplex serologic tests
Description
Description of the virological status of individuals by Mutiplex detection of antibodies directed against dengue, chikungunya and zika arboviruses.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Seroprevalence by area and age
Description
Estimatation of the frequency of Dengue, Chikungunya and zika infections among the general population of French Guiana by geographical area and by age class
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Dengue infections proportion
Description
Proportion of dengue primary and multiple infections in Guiana population.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Guiana resident for at least 6 months and present during the entire study period Age between 2 and 75 years old Exclusion Criteria: Subject under guardianship or deprived of liberty by judicial decision Subject with any pathology or health problem not compatible with blood sampling
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Flamand
Organizational Affiliation
Institut Pasteur de la Guyane
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Pasteur de la Guyane
City
Cayenne
ZIP/Postal Code
97306
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sero-epidemiology of Priority Arboviruses in French Guiana

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