CHIKGENE: Genetic Factors and Immunological Determinism of Persistent Consequences of Chikungunya

Sponsor
Centre Hospitalier Universitaire de la Réunion (Other)
Overall Status
Unknown status
CT.gov ID
NCT03690648
Collaborator
Conservatoire national des Arts et Métiers (Other)
600
1
17
35.3

Study Details

Study Description

Brief Summary

Chikungunya virus (CHIKV) infection has become a threat to public health worldwide. Reunion Island, due to the 2005-2006 epidemic, has acquired unique expertise and remains at the forefront of global research on this disease. The idea of genetic determinism of the clinical expression of infectious diseases has been supported by many epidemiological arguments over the past fifty years. The identification of genetic variants, associated with a disease, often allows a better understanding of the molecular mechanisms involved with consequent significant benefits such as the development of specific biomarkers for new preventive (vaccination) and / or therapeutic (drug design) approaches. In the absence of well-documented hypotheses about the genes potentially involved in the occurrence or evolution of a disease, genome-wide association studies (GWAS), whole genome, of nucleotide polymorphisms (SNPs) and the principle of linkage disequilibrium, under the commonly accepted hypothesis that the expression of a common disease is based on a small number of alleles commonly found in the population (frequency of minor allele greater than 1-5%), have become a method of choice, free of hypothesis, to specify the part of heritability of a complex disease and to identify its genetic determinants. Several epidemiological arguments support a significant proportion of genetic determinism in the explanation of the evolutionary pattern of Chikungunya, whose proportion of chronic forms can reach 40-60% in population-based studies conducted in the two years following an epidemic:

  • There are few risk factors associated with chronic forms and these appear to be unclear (age, comorbidities with several elements of the metabolic syndrome) or inconsistent (immune burden) in population studies;

  • The incidence of severe or atypical forms is rare in the order of 1% of infections;

  • In contrast to the acute phase (J1-J21) for which there seems to be a role of the viral load intensity and a consensual pro-inflammatory immune signature according to a recent meta-analysis]; The role of the intensity of the viral load in the pathogenesis of chronic arthralgia (> J90) and their immune signature remain to be determined, the latter being rather nonspecific, according to studies conducted in Reunion, Italy or Singapore.

These elements justify the interest of a GWAS in the Chikungunya to identify new avenues and mechanistic hypotheses likely to explain the chronic arthralgia characteristic of the disease.

Condition or Disease Intervention/Treatment Phase
  • Other: Quality of life survey
  • Genetic: Saliva collection
  • Genetic: Blood collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Genetic Factors and Immunological Determinism of Persistent Consequences of Chikungunya Fever: Genome-wide Association Study
Actual Study Start Date :
Aug 1, 2018
Anticipated Primary Completion Date :
Jul 31, 2019
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Saliva collection

Clinical examination; Quality of life survey; Saliva collection for genetical analysis

Other: Quality of life survey
Administration of scales: SF-12v2, EQ-5D, QCD, DN4, EIMIR, MFIS-5 et EHAD

Genetic: Saliva collection
Collection of 20 ml of saliva with a kit of saliva collection

Saliva and Blood collection

Clinical examination; Quality of life survey; Saliva and blood collection for genetical analysis

Other: Quality of life survey
Administration of scales: SF-12v2, EQ-5D, QCD, DN4, EIMIR, MFIS-5 et EHAD

Genetic: Saliva collection
Collection of 20 ml of saliva with a kit of saliva collection

Genetic: Blood collection
Collection of 20 ml of blood with kit of blood collection

Outcome Measures

Primary Outcome Measures

  1. identify by a genome-wide association study the genetic factors associated with the evolutionary profile of Chikungunya [through study completion, an average of 1 year]

    to determine if certain genetic profiles may be predictive of progression to asymptomatic or acute disease, or to the chronic character of the manifestations of the disease

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • -Subject of the seroprevalence survey or neighbor living in the same neighborhood likely to confirm an exposure status or known;

  • Exposure status established by specific IgG serology, collected between March 1st, 2005 and December 31st, 2006;

  • Affiliated to a social security scheme;

  • Age between 18 and 75 years old;

  • Paternal and maternal 1st and 2nd degree ascendants (parents and grandparents) and at least 3 generations of the family present on the island (grandparents born on the island of Réunion);

  • Able to spit

Exclusion Criteria:
  • Exposure status unknown;

  • Absence of social security;

  • Age <18 years and> 75 years;

  • Physical inability to spit;

  • Pregnant women;

  • Protected person (tutorship or curatorship).

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de La Réunion Saint-Pierre Réunion 97410

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de la Réunion
  • Conservatoire national des Arts et Métiers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier:
NCT03690648
Other Study ID Numbers:
  • 2016/CHU/12
First Posted:
Oct 1, 2018
Last Update Posted:
Oct 1, 2018
Last Verified:
Sep 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 1, 2018