Genetic Determinants of the Antiviral Immune Response in Oceanian Populations

NCT06432855 | Not Yet Recruiting

• 2 other identifiers: 2022-0352023-A02206-39
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Oceania's populations, including Melanesians, are paying a heavy price for dengue fever, which has been circulating actively in the region since the Second World War. In New Caledonia (NC), the incidence of dengue fever is higher among municipalities predominantly populated by Melanesians, suggesting that Melanesians may have an increased susceptibility to symptomatic dengue fever. Differences in antiviral immune responses between populations of different geographical origins are partly the result of population-specific immune regulatory variants. In turn, viruses have imposed considerable selective pressure on human populations. Although crucial to understanding their susceptibility to viral infections, the genetic determinants of the antiviral immune response of Oceanians remain to be characterized. In this context, the hypothesis is that the genetic origin of Oceanians, and Melanesians in particular, has shaped their antiviral immune response and contributes to their greater susceptibility to certain viral infections. The aim is to characterize the immune response to pathogens affecting the New Caledonian population, and in particular to dengue virus, of Melanesian and European populations, and to identify its genetic determinants. It will be explored whether saliva can be used as a non-invasive sample to study the seroprevalence of dengue in Oceanian populations.

Conditions

Virus

Keywords

dengue; immunity; genetics; Ocenian populations; New Caledonia

Outcome Measures

Primary Outcomes (1)

• Identify the genetic determinants of the innate immune response to pathogens affecting the New Caledonian population, and in particular to the dengue virus in individuals of Melanesian and European origin.

  Identification by genomic techniques of expression Quantitative Trait Loci (eQTL) specifically associated with the innate immune response of Peripheral Blood Mononuclear Cells (PBMCs) collected from individuals of Melanesian and European origin and stimulated in vitro by DENV.

  3 years

Secondary Outcomes (6)

• To describe the genetic diversity of Melanesian and European populations in NC in relation to the determinants of susceptibility to health problems affecting NC populations.

  3 years

• Characterizing the transcriptomic response to DENV in individuals of Melanesian and European origin.

  3 years

• Characterize the cytokine and chemokine response to DENV in individuals of Melanesian and European origin.

  3 years

• Study the effect of environmental factors (smoking/non-smoking status, history of Cytomegalovirus or dengue virus infection, presence of diabetes, etc.) on the immune response to dengue virus.

  3 years

• Study the oral microbiome of individuals of Melanesian and European origin and analyze its association with the immune response to pathogens.

  3 years

Study Arms (1)

Non-febrile adults of Melanesian and European origin

OTHER

Saliva samples and 20 mL blood samples from individuals of Melanesian and European origin from NC

Other: Blood collection; Other: saliva collection

Interventions

Blood collection OTHER

20 ml-blood sample

Non-febrile adults of Melanesian and European origin

saliva collection OTHER

saliva sample

Non-febrile adults of Melanesian and European origin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult
• Non-febrile
• Self-declared member of the Melanesian or European community
• Having given consent to participate in the study

You may not qualify if:

• People who have taken part in a clinical study in the last 6 months in which they were exposed to a health product as part of the investigation (pharmaceutical product or device or placebo).
• People taking part in an ongoing clinical study
• People declaring themselves to belong to two communities (e.g. people of mixed European and Melanesian descent)
• Pregnant and breast-feeding women (in whom the immune response could be modified)
• People with a long-term medical condition (as defined by the French social security system) that could have an effect on the immune response, excluding dengue risk factors prevalent in New Caledonia such as diabetes, overweight/obesity and hypertension.
• People with known allergies to antibiotics, which could have an impact on the in vitro culture of PBMCs in the presence of antibiotics
• Persons not intellectually capable of answering the questionnaire
• Persons under guardianship, curatorship or any other legal incapacity

Sponsors & Collaborators

• Institut Pasteur: lead

Study Sites (1)

Institut Pasteur de Nouvelle-Calédonie

Noumea, 98 835, New Caledonia

Location

MeSH Terms

Conditions

Virus Diseases; Dengue

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Marc Jouan, MD

  Institut Pasteur de Nouvelle-Calédonie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Inizan, PhD

CONTACT

+687 27 26 66; cinizan@pasteur.nc

Myrielle Dupont-Rouzeyrol, PhD

CONTACT

+687 27 75 30; mdupont@pasteur.nc

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: June 15, 2024
• Primary Completion: June 15, 2025
• Study Completion (Estimated): December 15, 2027
• Last Updated: June 24, 2024

Record last verified: 2024-05

Locations

NE (1)