Arbovirus InfectionsNCT03552094
World Mosquito Program Noumea - Human Sample Component
An observational study of Arbovirus Infections, run by Institut Pasteur at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arbovirus Infections
- What is being tested?
- Blood donations of hemochromatosis or polycythemia patients and Blood donations of healthy donors
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2018to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hemochromatosis or polycythemia patients requiring therapeutic bleeding that are not used in medical applications, and healthy donors.
Who may be able to join
- 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.
Who cannot join
- Participation refusal
- Minor person
- Positive result by Reverse transcription polymerase chain reaction RT-PCR for arboviruses
- Invalid qualification of the blood donation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Nouvelle-Calédonie
Nouméa, Nouvelle-Calédonie, 98 849
Frédéric Touzain, MD, +687209800, frederic.touzain@cht.nc
About this study
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.
Read the 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.
- Conditions
- Arbovirus Infections
- Being tested
- Blood donations of hemochromatosis or polycythemia patients, Blood donations of healthy donors
- Keywords
- Arbovirus
- Medical subject headings
- Arbovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood donations of hemochromatosis or polycythemia patientsOther
Blood samples are from blood donations of hemochromatosis or polycythemia patients requiring therapeutic bleeding that are not used in medical applications.
Blood donations of healthy donorsOther
Blood samples are from blood donations of healthy donors.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Blood donations of hemochromatosis or polycythemia patients | |
| Healthy donors | Blood samples from healthy donors. Blood bag (volume of blood: from 450 to 500 mL). Receives: Other: Blood donations of healthy donors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation of Aedes aegypti Caledonian lineages carrying the Wolbachia bacteria
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
Measured: 36 months
Maintenance and amplification of Aedes aegypti Caledonian lineages carrying the Wolbachia bacteria
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
Measured: 36 months
Secondary outcomes (1)
Vector competence assessment of the different Aedes aegypti Caledonian lineages
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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start25 Jun 2018
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arbovirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur of New Caledonia
- Responsible party
- Sponsor
- Investigators
- Frédéric Touzain, Principal investigator, Hospital Center of New CaledoniaMyrielle Dupont-Rouzeyrol, Principal investigator, Institut Pasteur of New Caledonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552094
- Sponsor's protocol ID
- 2017-036
- Status last verified
- Feb 2022
- First submitted
- 28 May 2018
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- World Mosquito Program Noumea - Human Sample Component
- ClinicalTrials.gov ID
- NCT03552094
- Acronym / sponsor ID
- 2017-036
- Conditions
- Arbovirus Infections
- Keywords
- Arbovirus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur of New Caledonia
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemochromatosis or polycythemia patients | – | Other: Blood donations of hemochromatosis or polycythemia patientsBlood 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). |
| Healthy donors | – | Other: Blood donations of healthy donorsBlood samples from healthy donors. Blood bag (volume of blood: from 450 to 500 mL). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hemochromatosis or polycythemia patients requiring therapeutic bleeding that are not used in medical applications, and healthy donors.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Participation refusal
- Minor person
- Positive result by Reverse transcription polymerase chain reaction RT-PCR for arboviruses
- Invalid qualification of the blood donation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood donations of hemochromatosis or polycythemia patientsBlood samples are from blood donations of hemochromatosis or polycythemia patients requiring therapeutic bleeding that are not used in medical applications. | Other | Hemochromatosis or polycythemia patients |
| Blood donations of healthy donorsBlood samples are from blood donations of healthy donors. | Other | Healthy donors |
Primary outcome
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
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
1 secondary outcome
Vector competence assessment of the different Aedes aegypti Caledonian lineages
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric Touzain principal investigator
Hospital Center of New Caledonia
Myrielle Dupont-Rouzeyrol principal investigator
Institut Pasteur of New Caledonia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arbovirus Infections, run by Institut Pasteur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Richard (+687 27.26.66, vrichard@pasteur.nc), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generation of Aedes aegypti Caledonian lineages carrying the Wolbachia bacteria (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022; AzTrials last refreshed its copy on 28 Oct 2026.