- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04619823
Virological and Immunological Determinants of Arbovirus Infection in New Caledonia (VIRIMA)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Myrielle Dupont-Rouzeyrol, PhD
- Phone Number: +687 27 75 30
- Email: mdupont@pasteur.nc
Study Contact Backup
- Name: Catherine Inizan, PhD
- Phone Number: +687 27 26 66
- Email: cinizan@pasteur.fr
Study Locations
-
-
-
Dumbéa Sur Mer, New Caledonia
- Recruiting
- Centre Hospitalier Territorial de Nouvelle-Calédonie
-
Contact:
- Myrielle Dupont Rouzeyrol, PhD
- Phone Number: +687 27 75 30
- Email: mdupont@pasteur.nc
-
Principal Investigator:
- Cécile Cazorla, MD
-
Principal Investigator:
- Mathieu Sérié, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patient infected by arboviruses
|
Blood sample collection Mosquito collection at home
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
Time Frame: 5 years
|
Measurement of dissemination of Aedes aegypti (carriers or not of Wolbachia) for arboviruses
|
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.
Time Frame: 5 years
|
Measurement of transmission of Aedes aegypti (carriers or not of Wolbachia) for arboviruses
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
5 years
|
|
Molecular characterization of arborviruses strains contained in mosquitoes present in patients' homes
Time Frame: 5 years
|
Whole genome sequencing and bioinformatics techniques as well as by in vitro infections of arbovirus strains contained in mosquitoes present in patients' homes
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Myrielle Dupont-Rouzeyrol, PhD, Institut Pasteur de Nouvelle-Calédonie
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-062
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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