Dengue Seroprevalence Study in Blood Donors in the French West Indies

Dengue Clinical Trial

— DengSeroprevAn  

Official title:

Dengue Seroprevalence Study in Blood Donors in the French West Indies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01104740
• Other study ID #: 10/B/01
• Secondary ID: 2010-A00385-34
• Status: Completed
• Start date: May 2011
• Est. completion date: May 2012

Study information

• Verified date: August 2021
• Source: Etablissement Français du Sang, Martinique
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Dengue is an infectious disease most prevalent in the world. This disease is endemic in the Caribbean, with an increase in seasonal rains. Several outbreaks have been observed in recent years, in 2001, 2005 and 2007, during which further particularly virulent serotypes have emerged. The clinical expression of dengue fever is variable, ranging from no symptoms to a classical form with fever, and even of severe or lethal bleeding. With the possible existence of silent forms of the disease, there are no data identifying the current level of protection of the population in Martinique / Guadeloupe.

Description:

1. Principal objective:

To estimate the prevalence of the specific antibodies of the dengue (IgG) in blood donors in the French West Indies.

2. Secondary objective:

To specify the serotypic specificity of the anti-dengue antibodies detected during the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 817
• Est. completion date: May 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Eligible for blood donation following the French legislation,

• Resident in Martinique /Guadeloupe for at least one year

• Consent signed

Exclusion Criteria:

• Not Eligible for blood donation following the French legislation,

• Not Resident in Martinique / Guadeloupe for at least one year

• Consent not signed

Related Conditions & MeSH terms

• Blood Donors
• Dengue

Intervention

Other:
• Biological sample collection
Blood (serum) sample collection

Locations

Country	Name	City	State
Guadeloupe	French Blood Establishment of Guadeloupe	Pointe-à-Pitre
Martinique	French Blood Establishment of Martinique	Fort-de-France

Sponsors (4)

Lead Sponsor	Collaborator
Etablissement Français du Sang, Martinique	Clinique Antilles-Guyane, Institut National de la Santé Et de la Recherche Médicale, France, Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

Guadeloupe,  Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or not of dengue virus-specific immunoglobulin G antibodies		1 day
Secondary	Characterization of dengue virus serotype-specific IgG	Characterization of dengue virus serotype-psecific IgG whendengue virus serotype-specific immunoglobulin G antibodies Test is positive	1 day