World Mosquito Program Noumea - Human Sample Component

February 14, 2022 updated by: Institut Pasteur

The dengue, Zika and chikungunya arboviruses represent potentially severe infections to which the New Caledonian population is exposed. In the absence of specific treatment or vaccine, vector control remains the method of choice to limit their spread. However, the traditional methods of prevention and vector control measure today face their limits: mosquito resistance to insecticides, difficulty of access and destruction of breeding areas... The World Mosquito Program Noumea project is based on the artificial colonization of the mosquito vector Aedes aegypti by the endosymbiotic bacteria Wolbachia, which reduces its ability to transmit arboviruses. The breeding of mosquitoes carrying the bacterium Wolbachia in the laboratories of the Institut Pasteur of New Caledonia requires the use of human blood samples for mosquito gorging.

The objective of the research is to generate, maintain and amplify Aedes aegypti Caledonian lineages carrying the Wolbachia bacteria for the planned insect release program in Noumea.

Study Overview

Detailed Description

The dengue, Zika and chikungunya arboviruses represent potentially severe infections to which the New Caledonian population is exposed. In the absence of specific treatment or vaccine, disease vector control remains the method of choice to limit their spread. However, the traditional methods of prevention and disease vector control must today face their limits: mosquito resistance to insecticides, difficulty of access and destruction of breeding areas... The World Mosquito Program Noumea project is based on the artificial colonization of the mosquito vector Aedes aegypti by the endosymbiotic bacterium Wolbachia, which reduces its ability to transmit arboviruses. The breeding of mosquitoes carrying the bacterium Wolbachia in the laboratories of the Institut Pasteur of New Caledonia requires the use of human blood samples for mosquito gorging.

The objective of the research is to generate, maintain and amplify Aedes aegypti Caledonian lineages carrying the bacterium Wolbachia for the planned insect release program in Noumea.

The establishment of Wolbachia in Aedes aegypti populations in Noumea should lead to the reduction of active transmission of dengue, Zika and chikungunya in the municipality.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Nouvelle-Calédonie
      • Nouméa, Nouvelle-Calédonie, France, 98 849
        • Recruiting
        • Centre Hospitalier de Nouvelle-Calédonie
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hemochromatosis or polycythemia patients requiring therapeutic bleeding that are not used in medical applications, and healthy donors.

Description

Inclusion Criteria:

  • All adult hemochromatosis or polycythemia patients or healthy donors have given their written consent to participate in the study and for the collection of a blood sample.

Exclusion Criteria:

  • Participation refusal
  • Minor person
  • Positive result by Reverse transcription polymerase chain reaction RT-PCR for arboviruses
  • Invalid qualification of the blood donation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hemochromatosis or polycythemia patients

Blood samples from hemochromatosis or polycythemia patients requiring therapeutic bleeding that are not used in medical applications.

Blood bag (volume of blood: from 450 to 500 mL).

Blood samples are from blood donations of hemochromatosis or polycythemia patients requiring therapeutic bleeding that are not used in medical applications.
Healthy donors
Blood samples from healthy donors. Blood bag (volume of blood: from 450 to 500 mL).
Blood samples are from blood donations of healthy donors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generation of Aedes aegypti Caledonian lineages carrying the Wolbachia bacteria
Time Frame: 36 months
Generation of Aedes aegypti Caledonian lineages carrying the Wolbachia bacteria for the planned insect release program in Noumea by measuring the Aedes aegypti female gorging rate
36 months
Maintenance and amplification of Aedes aegypti Caledonian lineages carrying the Wolbachia bacteria
Time Frame: 36 months
Maintenance and amplification of Aedes aegypti Caledonian lineages carrying the Wolbachia bacteria for the planned insect release program in Noumea by measuring the number of eggs per Aedes Aegypti female gorged
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vector competence assessment of the different Aedes aegypti Caledonian lineages
Time Frame: 36 months
Assessment of the vector competence for the dengue, Zika and chikungunya viruses of the different Aedes aegypti Caledonian lineages with or without Wolbachia bacteria carriage by measuring the transmissibility reduction of Aedes aegypti carrying Wolbachia for arboviruses
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Frédéric Touzain, Hospital Center of New Caledonia
  • Principal Investigator: Myrielle Dupont-Rouzeyrol, Institut Pasteur of New Caledonia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2018

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

May 28, 2018

First Submitted That Met QC Criteria

June 8, 2018

First Posted (Actual)

June 11, 2018

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-036

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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