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

NCT07000747 | Recruiting

• 2 other identifiers: PAP_RIPH3_2023/092019-A03033-54
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

extracellular vesicles; blood immune cells; Dengue virus

Outcome Measures

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.

  baseline

Secondary Outcomes (3)

• activation status of immune cells induced by DENV

  baseline

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

  baseline

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

  baseline

Study Arms (3)

Patients SS Group

Fifty SS patients

Patients SC

Fifty SC patients

Control group AA

Patients without hemoglobin disease

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (1)

Chu de La Guadeloupe

Pointe-à-Pitre, 97159, Guadeloupe

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

one blood collection will be realized during the annual follow up visit of the patients and during the screening visit for the controls

MeSH Terms

Conditions

Dengue; Virus Diseases; Fever; Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Maryse Etienne-Julan, MD PhD

  CHU de la Guadeloupe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie Hamony Soter

CONTACT

+590590934677; valerie.soter@chu-guadeloupe.fr

Mélanie petapermal

CONTACT

+590590934667; melanie.petapermal@chu-guadeloupe.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 3, 2025
• Study Start: June 24, 2024
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): June 24, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)