Arbovirus InfectionsVIRIMANCT04619823
Virological and Immunological Determinants of Arbovirus Infection in New Caledonia
A study testing Blood sample collection in people with Arbovirus Infections and Zika, run by Institut Pasteur at 1 site in New Caledonia.
Trial summary
Arboviruses, diseases transmitted to humans by the bite of an insect vector, are a major public health problem, particularly in tropical and sub-tropical countries. In New Caledonia, dengue epidemics are recurrent and may be associated with the co-circulation of other arboviruses such as Zika or chikungunya. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arbovirus Infections, Zika, Dengue
- What is being tested?
- Blood sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteNew Caledonia
- Study dates
- 15 Feb 2021to 15 Feb 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patient
- Patient with clinical signs suggestive of an arbovirus infection:
- Fever And at least 2 clinical signs suggestive of arbovirus among which myalgia, retro-orbital pain, drop in platelets (if data available), digestive symptoms, etc.
- Appearance of clinical signs suggestive of an arbovirus infection in the 7 days preceding the blood sample.
- Patient informed of the performance of the research, the collection of data and biological samples
- Patient who has given their consent to participate in the research by authorizing the collection of data, the collection of an additional blood sample and the use of this sample
Who cannot join
- Patient suffering from another identified virosis, an inflammatory disease or taking anti-inflammatory drugs
- Pregnant patient
- Patient returning from a trip within 15 days before the onset of the signs,
- Patient for whom the blood sample is incomplete or could not be performed
- Patient's condition, which, in the doctor's opinion, is incompatible with the additional sample required by the study
- Patient not having consented to participate in the research
Trial locations and contacts
1 site in 1 country.
New Caledonia1 site, 1 recruiting
- Recruiting
Centre Hospitalier Territorial de Nouvelle-Calédonie
Dumbéa Sur Mer
Myrielle Dupont Rouzeyrol, PhD, +687 27 75 30, mdupont@pasteur.nc
Cécile Cazorla, MD
About this study
Arboviruses, diseases transmitted to humans by the bite of an insect vector, are a major public health problem, particularly in tropical and sub-tropical countries. In New Caledonia, dengue epidemics are recurrent and may be associated with the co-circulation of other arboviruses such as Zika or chikungunya.
The virological determinants which condition the occurrence of these epidemics may be linked to an increased vectorial competence of the vector mosquito Aedes aegypti for a particular viral isolate. In fact, the Aedes aegypti mosquito is infected by making a blood meal on a person infected with an arbovirus. The virus infects its digestive tract, then spreads throughout the mosquito's body until it reaches its salivary glands. The virus is then present in the saliva and will be injected into the human host during a new blood meal. Some viral variants are best transmitted by Aedes aegypti. In general, the study of this vectorial competence is carried out by experiments in the laboratory during which an artificial blood meal composed of mammalian blood (human, rabbit, etc.) is mixed with a viral stock. Carrying out deported blood meals during which blood collected from patients infected with an arbovirus is used to gorge mosquitoes makes it possible to place oneself in experimental conditions as close as possible to the natural cycle of transmission of arboviruses.
In the human host, cells of the myeloid lineage present in the peripheral blood constitute preferred targets of replication for arboviruses. At the same time, the peripheral blood cells of patients are activated in response to infection and secrete many soluble factors released into the blood of patients. The study of blood samples from patients infected with arboviruses is therefore of prime importance for understanding both the replicative mechanisms of arboviruses but also the immune response they induce.
Read the detailed description
Collection of blood samples from adult patients with clinical signs suggestive of arbovirus
This study is a interventional study that present minimal risks and constraints.
This study will improve :
- the reliability of the results of vector competence experiments
- the understanding of the mechanisms of infection and replication of arboviruses
- the knowledge of the immune mechanisms involved in the response to infection by an arbovirus
- Conditions
- Arbovirus Infections, Zika, Dengue, Chikungunya
- Being tested
- Blood sample collection
- Keywords
- New Caledonia
- Medical subject headings
- Arbovirus Infections, Zika Virus Infection, Dengue, Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionOther
Blood sample collection Mosquito collection at home
| Study group | Role | What they receive |
|---|---|---|
| Patient infected by arboviruses | Other | Not described Receives: Other: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of vector competence parameters of Aedes aegypti (carriers or not of Wolbachia) for arboviruses by vector competence experiments using deported blood meals.
Rate of infection of Aedes aegypti (carriers or not of Wolbachia) for arboviruses
Measured: 5 years
Measurement of vector competence parameters of Aedes aegypti (carriers or not of Wolbachia) for arboviruses by vector competence experiments using deported blood meals.
Measurement of dissemination of Aedes aegypti (carriers or not of Wolbachia) for arboviruses
Measured: 5 years
Measurement of vector competence parameters of Aedes aegypti (carriers or not of Wolbachia) for arboviruses by vector competence experiments using deported blood meals.
Measurement of transmission of Aedes aegypti (carriers or not of Wolbachia) for arboviruses
Measured: 5 years
Secondary outcomes (2)
Molecular characterization of arborviruses strains included in the blood of patients and which may be diffused by mosquitoes carrying Wolbachia or not during deported blood meals
Whole genome sequencing and bioinformatics techniques as well as by in vitro infections of arbovirus strains included in the blood of patients and which may be diffused by mosquitoes carrying Wolbachia or not during deported blood meals
Measured: 5 years
Molecular characterization of arborviruses strains contained in mosquitoes present in patients' homes
Whole genome sequencing and bioinformatics techniques as well as by in vitro infections of arbovirus strains contained in mosquitoes present in patients' homes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start15 Feb 2021
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arbovirus InfectionsStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur de Nouvelle-Calédonie, Centre Hospitalier Territorial de Nouvelle-Calédonie
- Responsible party
- Sponsor
- Investigators
- Myrielle Dupont-Rouzeyrol, PhD, Principal investigator, Institut Pasteur de Nouvelle-Calédonie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619823
- Sponsor's protocol ID
- 2019-062
- Acronym
- VIRIMA
- Status last verified
- May 2024
- First submitted
- 18 Sep 2020
- Last updated
- 23 May 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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virological and Immunological Determinants of Arbovirus Infection in New Caledonia
- ClinicalTrials.gov ID
- NCT04619823
- Acronym / sponsor ID
- VIRIMA / 2019-062
- Conditions
- Arbovirus Infections, Zika, Dengue, Chikungunya
- Keywords
- New Caledonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur de Nouvelle-Calédonie, Centre Hospitalier Territorial de Nouvelle-Calédonie
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 6 Nov 2020 (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.
Arboviruses, diseases transmitted to humans by the bite of an insect vector, are a major public health problem, particularly in tropical and sub-tropical countries. In New Caledonia, dengue epidemics are recurrent and may be associated with the co-circulation of other arboviruses such as Zika or chikungunya.
The virological determinants which condition the occurrence of these epidemics may be linked to an increased vectorial competence of the vector mosquito Aedes aegypti for a particular viral isolate. In fact, the Aedes aegypti mosquito is infected by making a blood meal on a person infected with an arbovirus. The virus infects its digestive tract, then spreads throughout the mosquito's body until it reaches its salivary glands. The virus is then present in the saliva and will be injected into the human host during a new blood meal. Some viral variants are best transmitted by Aedes aegypti. In general, the study of this vectorial competence is carried out by experiments in the laboratory during which an artificial blood meal composed of mammalian blood (human, rabbit, etc.) is mixed with a viral stock. Carrying out deported blood meals during which blood collected from patients infected with an arbovirus is used to gorge mosquitoes makes it possible to place oneself in experimental conditions as close as possible to the natural cycle of transmission of arboviruses.
In the human host, cells of the myeloid lineage present in the peripheral blood constitute preferred targets of replication for arboviruses. At the same time, the peripheral blood cells of patients are activated in response to infection and secrete many soluble factors released into the blood of patients. The study of blood samples from patients infected with arboviruses is therefore of prime importance for understanding both the replicative mechanisms of arboviruses but also the immune response they induce.
Detailed description
Collection of blood samples from adult patients with clinical signs suggestive of arbovirus
This study is a interventional study that present minimal risks and constraints.
This study will improve :
- the reliability of the results of vector competence experiments
- the understanding of the mechanisms of infection and replication of arboviruses
- the knowledge of the immune mechanisms involved in the response to infection by an arbovirus
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient infected by arboviruses | Other | Other: Blood sample collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Major patient
- Patient with clinical signs suggestive of an arbovirus infection:
- Fever And at least 2 clinical signs suggestive of arbovirus among which myalgia, retro-orbital pain, drop in platelets (if data available), digestive symptoms, etc.
- Appearance of clinical signs suggestive of an arbovirus infection in the 7 days preceding the blood sample.
- Patient informed of the performance of the research, the collection of data and biological samples
Key exclusion criteria (6 listed)
- Patient suffering from another identified virosis, an inflammatory disease or taking anti-inflammatory drugs
- Pregnant patient
- Patient returning from a trip within 15 days before the onset of the signs,
- Patient for whom the blood sample is incomplete or could not be performed
- Patient's condition, which, in the doctor's opinion, is incompatible with the additional sample required by the study
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 sample collectionBlood sample collection Mosquito collection at home | Other | Patient infected by arboviruses |
Primary outcome
Measurement of vector competence parameters of Aedes aegypti (carriers or not of Wolbachia) for arboviruses by vector competence experiments using deported blood meals.
Time frame: 5 years
Rate of infection of Aedes aegypti (carriers or not of Wolbachia) for arboviruses
Measurement of vector competence parameters of Aedes aegypti (carriers or not of Wolbachia) for arboviruses by vector competence experiments using deported blood meals.
Time frame: 5 years
Measurement of dissemination of Aedes aegypti (carriers or not of Wolbachia) for arboviruses
Measurement of vector competence parameters of Aedes aegypti (carriers or not of Wolbachia) for arboviruses by vector competence experiments using deported blood meals.
Time frame: 5 years
Measurement of transmission of Aedes aegypti (carriers or not of Wolbachia) for arboviruses
2 secondary outcomes
Molecular characterization of arborviruses strains included in the blood of patients and which may be diffused by mosquitoes carrying Wolbachia or not during deported blood meals
Time frame: 5 years
Molecular characterization of arborviruses strains contained in mosquitoes present in patients' homes
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 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. This study is not recruiting at the moment.
Myrielle Dupont-Rouzeyrol, PhD 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 sample collection in people with Arbovirus Infections and Zika, 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 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: status not confirmed, as of the sponsor's last update on 23 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myrielle Dupont-Rouzeyrol, PhD (+687 27 75 30, mdupont@pasteur.nc), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of vector competence parameters of Aedes aegypti (carriers or not of Wolbachia) for arboviruses by vector competence experiments using deported blood meals. (time frame: 5 years). The study lists 3 primary outcomes in all. 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 23 May 2024.