Mosquito BiteEXPOCAPNCT05313126
Immuno-epidemiological and Socio-behavioral Evaluation of Release of Sterile Male Aedes Albopictus Mosquitoes on Human-vector Contacts
A study testing sterile insect technique (TIS) in people with Mosquito Bite, run by Institut de Recherche pour le Developpement at 1 site in France.
Trial summary
This trial is based on 2 complementary components, named ExpAlbo Biomarker and CAPAlbo Questionnaire 1. ExpAlbo Biomarker (Exposure to the Aedes albopictus mosquito): This component concerns the epidemiological evaluation of the effectiveness of the release of sterile male mosquitoes on the level of exposure of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mosquito Bite
- What is being tested?
- sterile insect technique (TIS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2021to Jun 2023
- Phase
- Interventional
- 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
Who may be able to join
- To inhabit on a regular basis in the intervention/control area
- To speak French
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
population générale (quartier Duparc (Sainte Marie) et Quartier Bois rouge)
La Réunion
Cécile Brengues, cecile.brengues@ird.fr
About this study
This trial is based on 2 complementary components, named ExpAlbo Biomarker and CAPAlbo Questionnaire
- ExpAlbo Biomarker (Exposure to the Aedes albopictus mosquito): This component concerns the epidemiological evaluation of the effectiveness of the release of sterile male mosquitoes on the level of exposure of individuals to the bites of the tiger mosquito through the use of a new immunological biomarker of the human-vector contact, developed over the past 20 years by the IRD-MIVEGEC team. Indeed, when a person is bitten by a mosquito, he or she develops a defence reaction, called an immune reaction, against the mosquito's saliva. The main objective of this study is to measure this immune response, and more specifically the antibody response specifically directed against compounds (peptide = small fragment of a protein) in mosquito saliva, and to determine whether this anti-saliva antibody response, and therefore exposure to mosquito bites, decreases when the mosquito control strategy is applied.
- CAPAlbo Questionnaire: This component is concerned with assessing the impact of sterile male mosquito releases on perceptions and practices related to exposure to Aedes albopictus based on population-based questionnaire surveys. The main objective of these surveys is to determine whether changes in objective exposure to Aedes albopictus mosquitoes are associated with changes in the perception of the nuisance and in the lifestyle habits of respondents, particularly those related to the prevention of mosquito bites (such as the use of repellents or mosquito nets).
- Conditions
- Mosquito Bite
- Being tested
- sterile insect technique (TIS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sterile insect technique (TIS)Other
Sterile male Aedes albopictus mosquitos are released in the area/neighborhood
| Study group | Role | What they receive |
|---|---|---|
| sterile male Aedes albopictus-exposed | Experimental | Sterile male Aedes albopictus are released in the area. Receives: Other: sterile insect technique (TIS) |
| control | No intervention | Sterile male Aedes albopictus are not released in the area. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological indicators
Biomarker based on the measurement of human IgG antibody levels specific to one peptide of Aedes saliva (i.e. Nterm-24kDa salivary peptide)
Measured: 6 months
Immunological indicators
Biomarker based on the measurement of human IgG antibody levels specific to one peptide of Aedes saliva (i.e. Nterm-24kDa salivary peptide)
Measured: 12 months
Exposure to Aedes mosquito
self-perceived exposure to mosquito will be assessed by questionnaire
Measured: 6 months
Exposure to Aedes mosquito
self-perceived exposure to mosquito will be assessed by questionnaire
Measured: 12 months
Secondary outcomes (2)
Protective behavior
a composite indicator derived from a questionnaire will rate the protective behavior of the participants to avoid mosquito bites
Measured: 6 months
Protective behavior
a composite indicator derived from a questionnaire will rate the protective behavior of the participants to avoid mosquito bites
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start9 Nov 2021
- 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 Mosquito BiteStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A Cluster-Non Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313126
- Sponsor's protocol ID
- 2020-A03558-31
- Acronym
- EXPOCAP
- Status last verified
- Mar 2022
- First submitted
- 5 Jan 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immuno-epidemiological and Socio-behavioral Evaluation of Release of Sterile Male Aedes Albopictus Mosquitoes on Human-vector Contacts
- ClinicalTrials.gov ID
- NCT05313126
- Acronym / sponsor ID
- EXPOCAP / 2020-A03558-31
- Conditions
- Mosquito Bite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 6 Apr 2022 (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.
This trial is based on 2 complementary components, named ExpAlbo Biomarker and CAPAlbo Questionnaire
- ExpAlbo Biomarker (Exposure to the Aedes albopictus mosquito): This component concerns the epidemiological evaluation of the effectiveness of the release of sterile male mosquitoes on the level of exposure of individuals to the bites of the tiger mosquito through the use of a new immunological biomarker of the human-vector contact, developed over the past 20 years by the IRD-MIVEGEC team. Indeed, when a person is bitten by a mosquito, he or she develops a defence reaction, called an immune reaction, against the mosquito's saliva. The main objective of this study is to measure this immune response, and more specifically the antibody response specifically directed against compounds (peptide = small fragment of a protein) in mosquito saliva, and to determine whether this anti-saliva antibody response, and therefore exposure to mosquito bites, decreases when the mosquito control strategy is applied.
- CAPAlbo Questionnaire: This component is concerned with assessing the impact of sterile male mosquito releases on perceptions and practices related to exposure to Aedes albopictus based on population-based questionnaire surveys. The main objective of these surveys is to determine whether changes in objective exposure to Aedes albopictus mosquitoes are associated with changes in the perception of the nuisance and in the lifestyle habits of respondents, particularly those related to the prevention of mosquito bites (such as the use of repellents or mosquito nets).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Cluster-Non Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| sterile male Aedes albopictus-exposed | Experimental | Other: sterile insect technique (TIS)Sterile male Aedes albopictus are released in the area. |
| control | No intervention | –Sterile male Aedes albopictus are not released in the area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To inhabit on a regular basis in the intervention/control area
- To speak French
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| sterile insect technique (TIS)Sterile male Aedes albopictus mosquitos are released in the area/neighborhood | Other | sterile male Aedes albopictus-exposed |
Primary outcome
Immunological indicators
Time frame: 6 months
Biomarker based on the measurement of human IgG antibody levels specific to one peptide of Aedes saliva (i.e. Nterm-24kDa salivary peptide)
Immunological indicators
Time frame: 12 months
Biomarker based on the measurement of human IgG antibody levels specific to one peptide of Aedes saliva (i.e. Nterm-24kDa salivary peptide)
Exposure to Aedes mosquito
Time frame: 6 months
self-perceived exposure to mosquito will be assessed by questionnaire
Exposure to Aedes mosquito
Time frame: 12 months
self-perceived exposure to mosquito will be assessed by questionnaire
2 secondary outcomes
Protective behavior
Time frame: 6 months
Protective behavior
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sterile insect technique (TIS) in people with Mosquito Bite, run by Institut de Recherche pour le Developpement 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 2 inclusion and 0 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 6 Apr 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 Franck Remoué, PhD (+33 (0)4 67 41 61 30, franck.remoue@ird.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological indicators (time frame: 6 months). The study lists 4 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 6 Apr 2022.