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RecruitingNCT07000747DREPADENGUEUpdated Jun 3, 2025

Molecular and Cellular Basis of Severe Forms of Dengue in Sickle Cell Patients

An observational study in Dengue (Virus); Fever, Sandfly and Sickle Cell Disease, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Recruiting at 1 site in Guadeloupe. Open to participants aged 6 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-03.

Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
130
Ages
6 Years to 25 Years
Sex
All
01

Study summary

Dengue virus (DENV) belongs to the genus of Flavivirus transmitted by the mosquito Aedes aegypti and is responsible for an infectious disease associated with different forms and severities such as dengue hemorrhagic fever or shock syndrome. Several recent reports have shown that sickle cell patients exhibited an increased risk of developing severe forms of dengue episodes compared to non-sickle cell subjects. Furthermore, among major sickle cell syndromes, these studies suggest that SC patients are at the highest risk of death during these infectious episodes although this sickle cell syndrome is generally associated with a more moderate expression of sickle cell disease. However, the mechanisms involved remain unknown to date.

The aim of the present study is to identify the molecular and cellular basis of this increased severity of dengue in SC patients. We hypothesize an exacerbation during DENV infection of the inflammatory response in SC patients compared to SS patients.

Read the detailed description

More precisely, the objective is to determine and compare the different cellular and molecular inflammatory mediators between SS and SC patients at baseline, and to study DENV-induced activation of various blood figurative elements isolated from uninfected sickle cell patients in vitro.

Given the essential role of immune cells in the DENV cycle and in the innate and adaptive immune responses of the host, understanding the changes induced by viral infection in Peripheral Blood Mononuclear Cells (PBMC) and Monocyte-Derived Dendritic Cells (MDDC) remains a priority. The effect of DENV or DENV-Associated Molecular Patterns (PAMPs) will therefore be studied in vitro on purified cells from SC and SS patients.

The impact of MicroParticles (MPs), known to be involved in the pathogenesis of severe dengue forms and in sickle cell disease, will also be evaluated on two cell types: endothelial cells and neutrophils, the latter exhibiting exacerbated activation and production of Neutrophil Extracellular Traps (NETs).

Considering the influence of mosquito saliva components on the pathogenesis of arboviruses (including DENV) in vertebrate hosts through the amplification of inflammatory responses, a comparative analysis of cellular and molecular inflammatory mediators released following exposure of blood cells from SS and SC patients to DENV and Aedes aegypti saliva will be conducted in vitro.

Lastly, the differential blood profiles of SS and SC patients will be assessed for their impact on the vector competence of Aedes aegypti mosquitoes in transmitting DENV.

02

Conditions studied

  • Dengue (Virus); Fever, Sandfly
  • Sickle Cell Disease

Keywords

  • extracellular vesicles
  • blood immune cells
  • Dengue virus
03

In context

Dengue

283 studies on the registry are indexed under Dengue; 44 are open to participants now.

This study's planned enrollment of 130 is below the median of 595 across 80 observational studies indexed under Dengue.

Browse Dengue studies →

Lead sponsor

Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

patients from 6 to 25 years, with sicke cell disease in a steady state at inclusion

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with SS or SC SCD or controls with AA
  • diagnosis of SCD performed by electrophoresis or HPLC in a reference laboratory for hemoglobinopathies
  • patients older than 6 years and younger than 25 at inclusion
  • clinically in a steady state at inclusion (without complication during the last month and without transfusion in the three last months)
  • patients followed up for SCD at the sickle cell center of Guadeloupe (University hospital of Guadeloupe, Pointe-à-Pitre)
  • patients or legal representatives of minors who will provide written in accordance with the Declaration of Helsinki
  • patients affiliated to national social security
  • the control group (AA subjects) will be recruited among volunteers recruited by posters

Exclusion criteria

Exclusion Criteria:

  • patients with SS or SC SCD or controls with AA
  • diagnosis of SCD performed by electrophoresis or HPLC in a reference laboratory for hemoglobinopathies
  • patients older than 6 years and younger than 25 at inclusion
  • clinically in a steady state at inclusion (without complication during the last month and without transfusion in the three last months)
  • patients followed up for SCD at the sickle cell center of Guadeloupe (University hospital of Guadeloupe, Pointe-à-Pitre)
  • patients or legal representatives of minors who will provide written in accordance with the Declaration of Helsinki
  • patients affiliated to national social security
  • the control group (AA subjects) will be recruited among volunteers recruited by posters
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
130 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patients SS Group

    Fifty SS patients

  • Patients SC

    Fifty SC patients

  • Control group AA

    Patients without hemoglobin disease

06

What researchers measure

Primary outcomes

  1. Lymphocyte subpopulations measured by flow cytometry at steady-state

    Comparison of circulating lymphocyte subpopulations in terms of activation and expression of markers of inflammation (cytokines, microparticles) and neutrophil proteome of SS and SC sickle cell patients at steady-state.

    Time frame: baseline

Secondary outcomes

  1. activation status of immune cells induced by DENV

    Quantification and comparison of activation state of immune cells (PBMC/monocytes) isolated from SS and SC sickle cell patients induced in vitro by DENV and/or DENV PAMPS (such as NS1 viral protein) in the presence or absence of mosquito saliva

    Time frame: baseline

  2. Comparative Analysis of NET Formation Induced by Sickle Cell-Derived Microparticles With or Without Mosquito Saliva

    Comparison of the induction properties of Neutrophil Extracellular Traps (NETs) in vitro by microparticles isolated from SS and SC patients in the presence or absence of mosquito saliva

    Time frame: baseline

  3. Impact of SS and SC Blood Profiles on Aedes aegypti Biting Behavior and Dengue Virus Transmission

    Evaluation of the influence of SS and SC blood profiles on the biting behavior of Aedes aegypti and its ability to transmit DENV.

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07000747
Lead sponsor
Centre Hospitalier Universitaire de la Guadeloupe
Responsible party
Sponsor
First posted
Jun 3, 2025
Start date
Jun 24, 2024
Primary completion
Jun 24, 2026 (estimated)
Completion
Jun 24, 2026 (estimated)
Last update
Jun 3, 2025

Study contacts

Valérie Hamony Soter
Contact
valerie.soter@chu-guadeloupe.fr
+590590934677
Mélanie petapermal
Contact
melanie.petapermal@chu-guadeloupe.fr
+590590934667
Maryse Etienne-Julan, MD PhD
principal investigator · CHU de la Guadeloupe

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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