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World Mosquito Program Noumea - Human Sample Component

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ClinicalTrials.gov Identifier: NCT03552094
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Institut Pasteur of New Caledonia
Information provided by (Responsible Party):
Institut Pasteur

Brief Summary:

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.


Condition or disease Intervention/treatment
Arbovirus Infections Other: Blood donations of hemochromatosis or polycythemia patients Other: Blood donations of healthy donors

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.


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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: World Mosquito Program Noumea - Human Sample Component
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


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).

Other: Blood donations of hemochromatosis or polycythemia patients
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).
Other: Blood donations of healthy donors
Blood samples are from blood donations of healthy donors.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Hemochromatosis or polycythemia patients requiring therapeutic bleeding that are not used in medical applications, and healthy donors.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552094


Contacts
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Contact: Vincent Richard +687 27.26.66 vrichard@pasteur.nc
Contact: Nicolas Pocquet +687 27.26.66 npocquet@pasteur.nc

Locations
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France
Centre Hospitalier de Nouvelle-Calédonie Recruiting
Nouméa, Nouvelle-Calédonie, France, 98 849
Contact: Frédéric Touzain, MD    +687209800    frederic.touzain@cht.nc   
Sponsors and Collaborators
Institut Pasteur
Institut Pasteur of New Caledonia
Investigators
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Principal Investigator: Frédéric Touzain Hospital Center of New Caledonia
Principal Investigator: Myrielle Dupont-Rouzeyrol Institut Pasteur of New Caledonia

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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT03552094     History of Changes
Other Study ID Numbers: 2017-036
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Pasteur:
Arbovirus
Additional relevant MeSH terms:
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Arbovirus Infections
Virus Diseases