Dengue Vaccine Strategy in Children Aged 9 to 17 Years in the French Caribbean

NCT04839757 | Recruiting

• 2 other identifiers: 19_RIPH3_192019-A02114-53
• Study Type: observational
• Target: 590
• Locations: 1 country
• Sites: 1

Brief Summary

Dengue fever, an arbovirus transmitted by the Aedes mosquito, is a public health problem in all tropical and subtropical regions of the world. There is currently no antiviral treatment and vector control has shown its limits. The 2018 European marketing authorization of the tetravalent chimeric yellow fever / dengue vaccine (Dengvaxia®) is a major step forward in the fight against the disease. Dengvaxia® is indicated for the prevention of dengue due to serotypes DENV 1-4 in subjects aged 9 to 45 years with a history of infection with the dengue virus and living in endemic areas (seroprevalence of at least 70% in the target population). Dengue seroprevalence data in the French Caribbean territories of Martinique and Guadeloupe dates back to 2011 and concerns only adult blood donors aged 18 to 70 years. To date, no data exists for individuals aged 9 to 17 years in the region. In order to implement an optimal vaccine introduction strategy for these territories, the main aim of the DengueSEA study is to estimate the seroprevalence of the Dengue viruses (DENV 1-4) in 9-17 year olds giving a blood sample as part of care in hospital departments of the French Caribbean islands of Martinique and Guadeloupe.

Conditions

Dengue; Vaccination; Seroprevalence; Infectious Disease

Keywords

dengue; seroprevalence; children; adolescents; vaccination strategy; French Carribean

Outcome Measures

Primary Outcomes (1)

• Dengue seroprevalence in the study population

  Number of anti-DENV IgG positive cases, with seroneutralization in favor of previous DENV infection, divided by the total number of 9-17 year odl children/adolescents included in the DengueSEA study

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Frequency of primary dengue fever

  through study completion, an average of 1 year

• Temporal variation of the risk of dengue infection

  through study completion, an average of 1 year

• Seroprevalence of Zika infection

  through study completion, an average of 1 year

• Assessment of Dengue vaccine acceptability/characterization of intentions and attitudes

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Any child aged 9 to 17 years presenting to one of the hospital departments participating in the study at the University Hospitals of Martinique or Guadeloupe who Need to take a blood sample or place a peripheral venous line for the management of the child Collection of the parent's or legal guardian's non-objection to participate in the Dengvaxia® vaccine acceptability survey

You may qualify if:

• Any child aged 9 to 17 years presenting to one of the hospital departments participating in the study at the University Hospitals of Martinique or Guadeloupe
• Need to take a blood sample or place a peripheral venous line for the management of the child
• Residence in Martinique or Guadeloupe since at least one year
• Information on the study given to the child and his/her parent or legal guardian
• Collection of the parent's or legal guardian's non-objection to the child's participation

You may not qualify if:

• Presence of fever or suspected acute infection
• Presence of an immune deficiency or any other dysimmune condition
• PARENTS
• Collection of the parent's or legal guardian's non-objection to participate in the Dengvaxia® vaccine acceptability survey
• Comprehension of spoken and written French
• \- None of the above

Sponsors & Collaborators

• University Hospital Center of Martinique: lead
• Ecole des Hautes Etudes en Santé Publique: collaborator
• University Hospital Center of Guadeloupe: collaborator
• Observatoire Regional de la Sante Provence-Alpes-Côte d'Azur: collaborator
• Modélisation Mathématique des Maladies Infectieuses UMR 2000, Institut Pasteur: collaborator
• Institut de Recherche en Santé Publique, France: collaborator
• Aix Marseille Université: collaborator

Study Sites (1)

Martinique University Hospital Center

Fort-de-France, Martinique

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Dengue; Communicable Diseases

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andre CABIE

  Martinique University Hospital Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique PELONDE-ERIMEE

CONTACT

0596592697; veronique.pelonde-erimee@chu-martinique.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 9, 2021
• Study Start: June 3, 2021
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

MA (1)