NCT04619823

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

5 years

First QC Date

September 18, 2020

Last Update Submit

May 22, 2024

Conditions

Keywords

New Caledonia

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    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

    5 years

  • Molecular characterization of arborviruses strains contained in mosquitoes present in patients' homes

    5 years

Study Arms (1)

Patient infected by arboviruses

OTHER
Other: Blood sample collection

Interventions

Blood sample collection Mosquito collection at home

Patient infected by arboviruses

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Territorial de Nouvelle-Calédonie

Dumbéa Sur Mer, New Caledonia

RECRUITING

MeSH Terms

Conditions

Arbovirus InfectionsZika Virus InfectionDengueChikungunya Fever

Condition Hierarchy (Ancestors)

Vector Borne DiseasesInfectionsVirus DiseasesMosquito-Borne DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, ViralAlphavirus InfectionsTogaviridae Infections

Study Officials

  • Myrielle Dupont-Rouzeyrol, PhD

    Institut Pasteur de Nouvelle-Calédonie

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Myrielle Dupont-Rouzeyrol, PhD

CONTACT

Catherine Inizan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2020

First Posted

November 6, 2020

Study Start

February 15, 2021

Primary Completion

February 15, 2026

Study Completion

February 15, 2026

Last Updated

May 23, 2024

Record last verified: 2024-05

Locations