DengueDengueSEANCT04839757
Dengue Vaccine Strategy in Children Aged 9 to 17 Years in the French Caribbean
An observational study of Dengue and Vaccination, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Dengue, Vaccination, Seroprevalence
- How many people
- 590 participants
- Where
- 1 siteMartinique
- Study dates
- 3 Jun 2021to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- Presence of fever or suspected acute infection
- Presence of an immune deficiency or any other dysimmune condition
- PARENTS
- Parental inclusion criteria ("vaccine acceptability" survey)
- 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
- Non-inclusion criteria for parents (vaccine acceptability survey)
- None of the above
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Martinique1 site, 1 recruiting
- Recruiting
Martinique University Hospital Center
Fort-de-France
Ornella Dr CABRAS
About this study
Official title: Preparing for the Use of a Dengue Vaccine in the French Caribbean Islands of Martinique and Guadeloupe : the DengueSEA Study
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.
Read the detailed description
The Dengvaxia® vaccine is being implemented in a difficult context: complex administration of the vaccine with the need to perform a biological test beforehand and to administer 3 vaccine doses, inconsistent efficacy, controversies and legal actions against the manufacturer in some countries where the vaccine has been used in children under 9 years of age, and general mistrust of vaccines, particularly the most recent ones.
In Martinique and Guadeloupe, where dengue circulates in an endo-epidemic mode, outbreaks involving all four DENV serotypes were observed in 1997, 2001, 2005, 2007, 2010 and 2013. Dengue seroprevalence for the region, estimated in 18-70 year old adult blood donors in 2011, was 93.5% (95% CI [91.5-95.1]). It was 86.7% (95% CI [69.3-96.2]) in 18- to 19-year-olds. A single dengue virus infection (primary dengue) was observed in 3% of dengue-positive donors. The remainder had been infected with two or more dengue viruses. To date, no such seroprevalence data exists for individuals aged 9 to 17 years in these regions, hence the DengueSEA study.
At the same time, a survey on the acceptability of dengue vaccination, conducted among parents/legal guardians of participating children/adolescents will allow the assessment of the degree of vaccine hesitancy, particularly for Dengvaxia®, and to identify its main determinants.
In addition, Martinique and Guadeloupe were affected in 2016 by an epidemic of the Zika virus infection, which affected 50 to 60% of the population. The antigenic relationship between dengue and Zika viruses can be the cause of serological cross-reactions and could have an impact on the efficacy and tolerance of dengue vaccines in individuals with a history of Zika virus infection. This justifies the conduct of a joint seroprevalence study of Zika and dengue virus infections in the study population.
The DengueSEA study is a key towards the implementation of an optimal dengue vaccination strategy for children aged 9 to 17 years in the French Caribbean. The results of this research will also permit better organization of health care services and better management of medical resources, particularly in anticipation of future dengue epidemics in the region. Potential vaccine acceptability challenges will also be better anticipated. Finally, the constitution of a biological collection will allow the evaluation of future serological tests developed to select eligible individuals for dengue vaccination, notably with Dengvaxia®, and to carry out further seroprevalence studies on arboviruses.
- Conditions
- Dengue, Vaccination, Seroprevalence, Infectious Disease
- Keywords
- dengue, seroprevalence, children, adolescents, vaccination strategy, French Carribean
- Medical subject headings
- Dengue, Communicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Frequency of primary dengue fever
Serum neutralisation with antibody titration by DENV serotype (DENV 1 to 4)
Measured: through study completion, an average of 1 year
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)
Measured: through study completion, an average of 1 year
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
Measured: through study completion, an average of 1 year
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).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start3 Jun 2021
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole des Hautes Etudes en Santé Publique, University Hospital Center of Guadeloupe, Observatoire Regional de la Sante Provence-Alpes-Côte d'Azur, Modélisation Mathématique des Maladies Infectieuses UMR 2000, Institut Pasteur, Institut de Recherche en Santé Publique, France, Aix Marseille Université
- Responsible party
- Sponsor
- Investigators
- Andre CABIE, Principal investigator, Martinique University Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839757
- Sponsor's protocol ID
- 19_RIPH3_19
- Other IDs
- 2019-A02114-53
- Acronym
- DengueSEA
- Status last verified
- Feb 2025
- First submitted
- 29 Mar 2021
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing for the Use of a Dengue Vaccine in the French Caribbean Islands of Martinique and Guadeloupe : the DengueSEA Study
- ClinicalTrials.gov ID
- NCT04839757
- Acronym / sponsor ID
- DengueSEA / 19_RIPH3_19
- Conditions
- Dengue, Vaccination, Seroprevalence, Infectious Disease
- Keywords
- dengue, seroprevalence, children, adolescents, vaccination strategy, French Carribean
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- Ecole des Hautes Etudes en Santé Publique, University Hospital Center of Guadeloupe, Observatoire Regional de la Sante Provence-Alpes-Côte d'Azur, Modélisation Mathématique des Maladies Infectieuses UMR 2000, Institut Pasteur, Institut de Recherche en Santé Publique, France, Aix Marseille Université
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Dengvaxia® vaccine is being implemented in a difficult context: complex administration of the vaccine with the need to perform a biological test beforehand and to administer 3 vaccine doses, inconsistent efficacy, controversies and legal actions against the manufacturer in some countries where the vaccine has been used in children under 9 years of age, and general mistrust of vaccines, particularly the most recent ones.
In Martinique and Guadeloupe, where dengue circulates in an endo-epidemic mode, outbreaks involving all four DENV serotypes were observed in 1997, 2001, 2005, 2007, 2010 and 2013. Dengue seroprevalence for the region, estimated in 18-70 year old adult blood donors in 2011, was 93.5% (95% CI [91.5-95.1]). It was 86.7% (95% CI [69.3-96.2]) in 18- to 19-year-olds. A single dengue virus infection (primary dengue) was observed in 3% of dengue-positive donors. The remainder had been infected with two or more dengue viruses. To date, no such seroprevalence data exists for individuals aged 9 to 17 years in these regions, hence the DengueSEA study.
At the same time, a survey on the acceptability of dengue vaccination, conducted among parents/legal guardians of participating children/adolescents will allow the assessment of the degree of vaccine hesitancy, particularly for Dengvaxia®, and to identify its main determinants.
In addition, Martinique and Guadeloupe were affected in 2016 by an epidemic of the Zika virus infection, which affected 50 to 60% of the population. The antigenic relationship between dengue and Zika viruses can be the cause of serological cross-reactions and could have an impact on the efficacy and tolerance of dengue vaccines in individuals with a history of Zika virus infection. This justifies the conduct of a joint seroprevalence study of Zika and dengue virus infections in the study population.
The DengueSEA study is a key towards the implementation of an optimal dengue vaccination strategy for children aged 9 to 17 years in the French Caribbean. The results of this research will also permit better organization of health care services and better management of medical resources, particularly in anticipation of future dengue epidemics in the region. Potential vaccine acceptability challenges will also be better anticipated. Finally, the constitution of a biological collection will allow the evaluation of future serological tests developed to select eligible individuals for dengue vaccination, notably with Dengvaxia®, and to carry out further seroprevalence studies on arboviruses.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Presence of fever or suspected acute infection
- Presence of an immune deficiency or any other dysimmune condition
- PARENTS
- Parental inclusion criteria ("vaccine acceptability" survey)
- Collection of the parent's or legal guardian's non-objection to participate in the Dengvaxia® vaccine acceptability survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dengue seroprevalence in the study population
Time frame: through study completion, an average of 1 year
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
4 secondary outcomes
Frequency of primary dengue fever
Time frame: through study completion, an average of 1 year
Temporal variation of the risk of dengue infection
Time frame: through study completion, an average of 1 year
Seroprevalence of Zika infection
Time frame: through study completion, an average of 1 year
Assessment of Dengue vaccine acceptability/characterization of intentions and attitudes
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andre CABIE principal investigator
Martinique University Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue and Vaccination, run by University Hospital Center of Martinique at 1 site in Martinique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Véronique PELONDE-ERIMEE (0596592697, veronique.pelonde-erimee@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dengue seroprevalence in the study population (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.