Why dengue is more severe in people with sickle cell disease
Molecular and Cellular Basis of Severe Forms of Dengue in Sickle Cell Patients
This project will test whether immune cells and tiny blood particles from young people with SC or SS sickle cell disease respond differently to dengue virus compared with healthy controls, which could explain more severe infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 6 Years to 25 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de la Guadeloupe Academic / other |
| Locations | 1 site (Pointe-à-Pitre) |
| Trial ID | NCT07000747 on ClinicalTrials.gov |
What this trial studies
This observational study compares blood samples from SC and SS sickle cell patients and healthy AA controls aged 6–25 who are clinically stable. Researchers will isolate peripheral blood mononuclear cells and monocyte-derived dendritic cells and expose them in vitro to dengue virus, dengue-associated molecular patterns, and Aedes aegypti saliva to measure cellular activation and inflammatory mediator release. They will also study microparticles' effects on endothelial cells and neutrophil activation including neutrophil extracellular trap formation. The aim is to identify molecular and cellular differences that might explain the higher risk of severe dengue in SC patients.
Who should consider this trial
Good fit: Ideal candidates are people aged 6–25 with genetically confirmed SS or SC sickle cell disease or healthy AA controls, clinically steady and followed at the sickle cell center of the University Hospital of Guadeloupe, who can give informed consent.
Not a fit: People outside the 6–25 age range, those with recent sickle cell complications or transfusions, or not followed at the Guadeloupe center are not eligible and would likely not benefit from this protocol.
Why it matters
Potential benefit: If successful, the work could identify immune mechanisms or biomarkers that help predict or prevent severe dengue in people with sickle cell disease.
How similar studies have performed: Previous work has linked microparticles, neutrophil activation and immune responses to severe dengue and to sickle cell complications, but directly comparing SC versus SS patient cells with dengue exposure is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with SS or SC SCD or controls with hemoglobin 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 informed consent 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: * patients with SS or SC SCD or controls with hemoglobin 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 informed consent 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
Where this trial is running
Pointe-à-Pitre
- Chu de La Guadeloupe — Pointe-à-Pitre, Guadeloupe (Recruiting)
Study contacts
- Principal investigator: Maryse Etienne-Julan, MD PhD — CHU de la Guadeloupe
- Study coordinator: Valérie Hamony Soter
- Email: valerie.soter@chu-guadeloupe.fr
- Phone: +590590934677
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.