Back to resultsImmuno-epidemiological and Socio-behavioral Evaluation of Release of Sterile Male Aedes Albopictus Mosquitoes on Human-vector Contacts (EXPOCAP)
Primary Purpose
Mosquito Bite
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sterile insect technique (TIS)
Sponsored by
About this trial
This is an interventional prevention trial for Mosquito Bite
Eligibility Criteria
Inclusion Criteria:
- To inhabit on a regular basis in the intervention/control area
- To speak French
Sites / Locations
- population générale (quartier Duparc (Sainte Marie) et Quartier Bois rouge)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
sterile male Aedes albopictus-exposed
control
Arm Description
Sterile male Aedes albopictus are released in the area.
Sterile male Aedes albopictus are not released in the area.
Outcomes
Primary Outcome Measures
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)
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)
Exposure to Aedes mosquito
self-perceived exposure to mosquito will be assessed by questionnaire
Exposure to Aedes mosquito
self-perceived exposure to mosquito will be assessed by questionnaire
Secondary Outcome Measures
Protective behavior
a composite indicator derived from a questionnaire will rate the protective behavior of the participants to avoid mosquito bites
Protective behavior
a composite indicator derived from a questionnaire will rate the protective behavior of the participants to avoid mosquito bites
Full Information
NCT ID
NCT05313126
First Posted
January 5, 2022
Last Updated
March 28, 2022
Sponsor
Institut de Recherche pour le Developpement
1. Study Identification
Unique Protocol Identification Number
NCT05313126
Brief Title
Immuno-epidemiological and Socio-behavioral Evaluation of Release of Sterile Male Aedes Albopictus Mosquitoes on Human-vector Contacts
Acronym
EXPOCAP
Official Title
Immuno-epidemiological and Socio-behavioral Evaluation of Release of Sterile Male Aedes Albopictus Mosquitoes on Human-vector Contacts
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherche pour le Developpement
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mosquito Bite
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Cluster-Non Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sterile male Aedes albopictus-exposed
Arm Type
Experimental
Arm Description
Sterile male Aedes albopictus are released in the area.
Arm Title
control
Arm Type
No Intervention
Arm Description
Sterile male Aedes albopictus are not released in the area.
Intervention Type
Other
Intervention Name(s)
sterile insect technique (TIS)
Intervention Description
Sterile male Aedes albopictus mosquitos are released in the area/neighborhood
Primary Outcome Measure Information:
Title
Immunological indicators
Description
Biomarker based on the measurement of human IgG antibody levels specific to one peptide of Aedes saliva (i.e. Nterm-24kDa salivary peptide)
Time Frame
6 months
Title
Immunological indicators
Description
Biomarker based on the measurement of human IgG antibody levels specific to one peptide of Aedes saliva (i.e. Nterm-24kDa salivary peptide)
Time Frame
12 months
Title
Exposure to Aedes mosquito
Description
self-perceived exposure to mosquito will be assessed by questionnaire
Time Frame
6 months
Title
Exposure to Aedes mosquito
Description
self-perceived exposure to mosquito will be assessed by questionnaire
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Protective behavior
Description
a composite indicator derived from a questionnaire will rate the protective behavior of the participants to avoid mosquito bites
Time Frame
6 months
Title
Protective behavior
Description
a composite indicator derived from a questionnaire will rate the protective behavior of the participants to avoid mosquito bites
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
To inhabit on a regular basis in the intervention/control area
To speak French
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Franck Remoué, PhD
Phone
+33 (0)4 67 41 61 30
Email
franck.remoue@ird.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyn Raude, PhD
Phone
+33 (0)2 99 02 26 15
Email
jocelyn.raude@ehesp.fr
Facility Information:
Facility Name
population générale (quartier Duparc (Sainte Marie) et Quartier Bois rouge)
City
La Réunion
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile Brengues
Email
cecile.brengues@ird.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Immuno-epidemiological and Socio-behavioral Evaluation of Release of Sterile Male Aedes Albopictus Mosquitoes on Human-vector Contacts
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