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Virological and Immunological Determinants of Arbovirus Infection in New Caledonia (VIRIMA)

Primary Purpose

Arbovirus Infections, Zika, Dengue

Status
Recruiting
Phase
Not Applicable
Locations
New Caledonia
Study Type
Interventional
Intervention
Blood sample collection
Sponsored by
Institut Pasteur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Arbovirus Infections focused on measuring New Caledonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Territorial de Nouvelle-CalédonieRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patient infected by arboviruses

Arm Description

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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
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

Full Information

First Posted
September 18, 2020
Last Updated
October 6, 2022
Sponsor
Institut Pasteur
Collaborators
Institut Pasteur de Nouvelle-Calédonie, Centre Hospitalier Territorial de Nouvelle-Calédonie
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1. Study Identification

Unique Protocol Identification Number
NCT04619823
Brief Title
Virological and Immunological Determinants of Arbovirus Infection in New Caledonia
Acronym
VIRIMA
Official Title
Virological and Immunological Determinants of Arbovirus Infection in New Caledonia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
February 15, 2026 (Anticipated)
Study Completion Date
February 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Pasteur
Collaborators
Institut Pasteur de Nouvelle-Calédonie, Centre Hospitalier Territorial de Nouvelle-Calédonie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arbovirus Infections, Zika, Dengue, Chikungunya
Keywords
New Caledonia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient infected by arboviruses
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Blood sample collection
Intervention Description
Blood sample collection Mosquito collection at home
Primary Outcome Measure Information:
Title
Measurement of vector competence parameters of Aedes aegypti (carriers or not of Wolbachia) for arboviruses by vector competence experiments using deported blood meals.
Description
Rate of infection of Aedes aegypti (carriers or not of Wolbachia) for arboviruses
Time Frame
5 years
Title
Measurement of vector competence parameters of Aedes aegypti (carriers or not of Wolbachia) for arboviruses by vector competence experiments using deported blood meals.
Description
Measurement of dissemination of Aedes aegypti (carriers or not of Wolbachia) for arboviruses
Time Frame
5 years
Title
Measurement of vector competence parameters of Aedes aegypti (carriers or not of Wolbachia) for arboviruses by vector competence experiments using deported blood meals.
Description
Measurement of transmission of Aedes aegypti (carriers or not of Wolbachia) for arboviruses
Time Frame
5 years
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
5 years
Title
Molecular characterization of arborviruses strains contained in mosquitoes present in patients' homes
Description
Whole genome sequencing and bioinformatics techniques as well as by in vitro infections of arbovirus strains contained in mosquitoes present in patients' homes
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myrielle Dupont-Rouzeyrol, PhD
Phone
+687 27 75 30
Email
mdupont@pasteur.nc
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Inizan, PhD
Phone
+687 27 26 66
Email
cinizan@pasteur.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myrielle Dupont-Rouzeyrol, PhD
Organizational Affiliation
Institut Pasteur de Nouvelle-Calédonie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Territorial de Nouvelle-Calédonie
City
Dumbéa Sur Mer
Country
New Caledonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myrielle Dupont Rouzeyrol, PhD
Phone
+687 27 75 30
Email
mdupont@pasteur.nc
First Name & Middle Initial & Last Name & Degree
Cécile Cazorla, MD
First Name & Middle Initial & Last Name & Degree
Mathieu Sérié, MD

12. IPD Sharing Statement

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Virological and Immunological Determinants of Arbovirus Infection in New Caledonia

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