Chikungunya FeverCHIKGENENCT03690648
Genetic Factors and Immunological Determinism of Persistent Consequences of Chikungunya
An observational study of Chikungunya Fever, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chikungunya Fever
- What is being tested?
- Quality of life survey, Saliva collection and Blood collection
- How many people
- 600 participants
- Where
- 1 siteReunion
- Study dates
- 1 Aug 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject with a serological status known for Chikungunya virus for the period between March 1st, 2005 and December 31st, 2006 (epidemic period in reunion Island).
Who may be able to join
- -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
Who cannot join
- Exposure status unknown;
- Absence of social security;
- Age <18 years and> 75 years;
- Physical inability to spit;
- Pregnant women;
- Protected person (tutorship or curatorship).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetic Factors and Immunological Determinism of Persistent Consequences of Chikungunya Fever: Genome-wide Association Study
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.
- Conditions
- Chikungunya Fever
- Being tested
- Quality of life survey, Saliva collection, Blood collection
- Medical subject headings
- Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life surveyOther
Administration of scales: SF-12v2, EQ-5D, QCD, DN4, EIMIR, MFIS-5 et EHAD
Saliva collectionGenetic
Collection of 20 ml of saliva with a kit of saliva collection
Blood collectionGenetic
Collection of 20 ml of blood with kit of blood collection
| Study group | Role | What they receive |
|---|---|---|
| Saliva collection | * Clinical examination;
* Quality of life survey;
* Saliva collection for genetical analysis Receives: Other: Quality of life survey; Genetic: Saliva collection | |
| Saliva and Blood collection | * Clinical examination;
* Quality of life survey;
* Saliva and blood collection for genetical analysis Receives: Other: Quality of life survey; Genetic: Saliva collection; Genetic: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
identify by a genome-wide association study the genetic factors associated with the evolutionary profile of Chikungunya
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 Aug 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chikungunya FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Collaborators
- Conservatoire national des Arts et Métiers
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690648
- Sponsor's protocol ID
- 2016/CHU/12
- Acronym
- CHIKGENE
- Status last verified
- Aug 2022
- First submitted
- 26 Sep 2018
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Factors and Immunological Determinism of Persistent Consequences of Chikungunya Fever: Genome-wide Association Study
- ClinicalTrials.gov ID
- NCT03690648
- Acronym / sponsor ID
- CHIKGENE / 2016/CHU/12
- Conditions
- Chikungunya Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Collaborators
- Conservatoire national des Arts et Métiers
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saliva collection | – | Other: Quality of life survey, Genetic: Saliva collection* Clinical examination; * Quality of life survey; * Saliva collection for genetical analysis |
| Saliva and Blood collection | – | Other: Quality of life survey, Genetic: Saliva collection, Genetic: Blood collection* Clinical examination; * Quality of life survey; * Saliva and blood collection for genetical analysis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject with a serological status known for Chikungunya virus for the period between March 1st, 2005 and December 31st, 2006 (epidemic period in reunion Island).
Key inclusion criteria (6 listed)
- -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);
Key exclusion criteria (6 listed)
- Exposure status unknown;
- Absence of social security;
- Age <18 years and> 75 years;
- Physical inability to spit;
- Pregnant women;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life surveyAdministration of scales: SF-12v2, EQ-5D, QCD, DN4, EIMIR, MFIS-5 et EHAD | Other | Saliva and Blood collection, Saliva collection |
| Saliva collectionCollection of 20 ml of saliva with a kit of saliva collection | Genetic | Saliva and Blood collection, Saliva collection |
| Blood collectionCollection of 20 ml of blood with kit of blood collection | Genetic | Saliva and Blood collection |
Primary outcome
identify by a genome-wide association study the genetic factors associated with the evolutionary profile of Chikungunya
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chikungunya Fever, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identify by a genome-wide association study the genetic factors associated with the evolutionary profile of Chikungunya (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.