VirusGEDIPOPNCT06432855
Genetic Determinants of the Antiviral Immune Response in Oceanian Populations
A study testing Blood collection and saliva collection in people with Virus, run by Institut Pasteur at 1 site in New Caledonia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virus
- What is being tested?
- Blood collection and saliva collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteNew Caledonia
- Study dates
- 15 Jun 2024to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult
- Non-febrile
- Self-declared member of the Melanesian or European community
- Having given consent to participate in the study
Who cannot join
- 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.
- Individuals with an acute infection (viral, bacterial or fungal) within 3 months of inclusion.
Show all 12Show fewer
- Chronic administration (for more than 14 days) of immunosuppressants or treatments affecting the immune system in the 6 months prior to inclusion. For corticosteroids, this corresponds to a dose equivalent to 20 mg/day of prednisone or equivalent for more than two weeks (inhaled or topical steroids are permitted).
- Administration of a vaccine within 3 months prior to inclusion.
- Administration of blood products or immunoglobulins within 3 months of inclusion.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
New Caledonia1 site
Institut Pasteur de Nouvelle-Calédonie
Noumea, 98 835
Marc Jouan, MD
About this study
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.
Read the detailed description
Cross-sectional observational study with prospective sample and data collection Individuals will be identified from among eligible participants in the STEP-BSA21 and COVCAL studies.
Information and consent Questionnaire, saliva collection on Oragene tube, buccal swabbing and 20 mL blood collection on CPT tube
DNA extraction and low-coverage sequencing of participants' complete genomes And Isolation and in vitro stimulation of peripheral blood mononuclear cells (PBMCs) with dengue virus
- single-cell RNA sequencing (scRNAseq)
- multiplex quantification of cytokines and chemokines
- bioinformatics analysis to identify genetic markers associated with a differential transcriptomic and secretory response to dengue virus stimulation.
- Conditions
- Virus
- Being tested
- Blood collection, saliva collection
- Keywords
- dengue, immunity, genetics, Ocenian populations, New Caledonia
- Medical subject headings
- Virus Diseases, Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
20 ml-blood sample
saliva collectionOther
saliva sample
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Blood collection; Other: saliva collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Low-coverage DNA sequencing of the complete genome of individuals of Melanesian and European origin.
Measured: 3 years
Characterizing the transcriptomic response to DENV in individuals of Melanesian and European origin.
Quantification by single cell RNAseq techniques of differentially expressed transcripts in response to in vitro dengue virus stimulation by Peripheral Blood Mononuclear Cells (PBMCs) collected from individuals of Melanesian and European origin.
Measured: 3 years
Characterize the cytokine and chemokine response to DENV in individuals of Melanesian and European origin.
Quantification by multiplex techniques of the concentration of cytokines and chemokines differentially secreted in response to in vitro stimulation by dengue virus by Peripheral Blood Mononuclear Cells (PBMCs) collected from individuals of Melanesian and European origin.
Measured: 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.
Multivariate analyses of the association of environmental factors collected during the inclusion visit (questionnaire and measurements) or during analyses conducted as part of the present research with the immune response targeting the dengue virus.
Measured: 3 years
Study the oral microbiome of individuals of Melanesian and European origin and analyze its association with the immune response to pathogens.
Next-generation sequencing and analysis of the oral microbiome on a saliva sample
Measured: 3 years
Determine whether history of dengue virus infection can be demonstrated by testing saliva for antibodies using the Luminex technique.
Luminex quantification of dengue virus antibodies in serum and saliva from Melanesian and European individuals.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VirusStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Jouan, MD, Principal investigator, Institut Pasteur de Nouvelle-Calédonie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432855
- Sponsor's protocol ID
- 2022-035
- Other IDs
- 2023-A02206-39
- Acronym
- GEDIPOP
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Determinants of the Antiviral Immune Response in Oceanian Populations
- ClinicalTrials.gov ID
- NCT06432855
- Acronym / sponsor ID
- GEDIPOP / 2022-035
- Conditions
- Virus
- Keywords
- dengue, immunity, genetics, Ocenian populations, New Caledonia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 29 May 2024 (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.
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.
Detailed description
Cross-sectional observational study with prospective sample and data collection Individuals will be identified from among eligible participants in the STEP-BSA21 and COVCAL studies.
Information and consent Questionnaire, saliva collection on Oragene tube, buccal swabbing and 20 mL blood collection on CPT tube
DNA extraction and low-coverage sequencing of participants' complete genomes And Isolation and in vitro stimulation of peripheral blood mononuclear cells (PBMCs) with dengue virus
- single-cell RNA sequencing (scRNAseq)
- multiplex quantification of cytokines and chemokines
- bioinformatics analysis to identify genetic markers associated with a differential transcriptomic and secretory response to dengue virus stimulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-febrile adults of Melanesian and European origin | Other | Other: Blood collection, Other: saliva collectionSaliva samples and 20 mL blood samples from individuals of Melanesian and European origin from NC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult
- Non-febrile
- Self-declared member of the Melanesian or European community
- Having given consent to participate in the study
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| Blood collection20 ml-blood sample | Other | Non-febrile adults of Melanesian and European origin |
| saliva collectionsaliva sample | Other | Non-febrile adults of Melanesian and European origin |
Primary outcome
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.
Time frame: 3 years
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.
6 secondary outcomes
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.
Time frame: 3 years
Characterizing the transcriptomic response to DENV in individuals of Melanesian and European origin.
Time frame: 3 years
Characterize the cytokine and chemokine response to DENV in individuals of Melanesian and European origin.
Time frame: 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.
Time frame: 3 years
Study the oral microbiome of individuals of Melanesian and European origin and analyze its association with the immune response to pathogens.
Time frame: 3 years
Determine whether history of dengue virus infection can be demonstrated by testing saliva for antibodies using the Luminex technique.
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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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.
Marc Jouan, MD principal investigator
Institut Pasteur de Nouvelle-Calédonie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood collection and saliva collection in people with Virus, run by Institut Pasteur at 1 site in New Caledonia.
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 4 inclusion and 12 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: opening soon, as of the sponsor's last update on 24 Jun 2024. 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 New Caledonia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Inizan, PhD (+687 27 26 66, cinizan@pasteur.nc), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3 years). 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 24 Jun 2024.