Dengue Vaccine Strategy in Children Aged 9 to 17 Years in the French Caribbean
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age9-17
SponsorUniversity Hospital Center of Martinique
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Presence of fever or suspected acute infection
Presence of an immune deficiency or any other dysimmune condition
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
Trial 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
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Frequency of primary dengue fever
Serum neutralisation with antibody titration by DENV serotype (DENV 1 to 4)
Time frame
through study completion, an average of 1 year2
Temporal variation of the risk of dengue infection
Implementation of a mathematical prediction model, based on a dynamic mode of infection during dengue epidemics in the French Caribbean, and taking into account dengue seroprevalence and surveillance data in the region since 2001 (Public Health France, sentinel physicians network)
Time frame
through study completion, an average of 1 year3
Seroprevalence of Zika infection
anti-ZIKV IgG positivity and seroneutralization in favor of a previous Zika virus infection divided by the total number of children included in the DengueSEA study
Time frame
through study completion, an average of 1 year4
Assessment of Dengue vaccine acceptability/characterization of intentions and attitudes
Questionnaire developed using the "3C" model developed by the WHO SAGE group to predict the degree of vaccine hesitancy, i.e., the refusal or postponement of certain vaccinations despite the availability of these products. The factors favored by this model are confidence in the safety of the vaccine (Confidence), perception of the importance of the targeted vaccination (Complacency), and perceived difficulties in obtaining this vaccination (Convenience).
Time frame
through study completion, an average of 1 yearSponsors and contacts
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University Hospital Center of Martinique
Lead sponsor
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
Source ClinicalTrials.gov