Immuno-epidemiological and Socio-behavioral Evaluation of Release of Sterile Male Aedes Albopictus Mosquitoes on Human-vector Contacts (EXPOCAP)

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 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.
2. 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 Overview

• Status: Recruiting
• Conditions: Mosquito Bite
• Intervention / Treatment: Other: sterile insect technique (TIS)

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Franck Remoué, PhD; Phone Number: +33 (0)4 67 41 61 30; Email: franck.remoue@ird.fr
• Study Contact Backup: Name: Jocelyn Raude, PhD; Phone Number: +33 (0)2 99 02 26 15; Email: jocelyn.raude@ehesp.fr

Study Locations

• France
  • La Réunion, France
    • Recruiting
    • population générale (quartier Duparc (Sainte Marie) et Quartier Bois rouge)
    • Contact: Cécile Brengues; Email: cecile.brengues@ird.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• To inhabit on a regular basis in the intervention/control area
• To speak French

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sterile male Aedes albopictus-exposed; Sterile male Aedes albopictus are released in the area.	Other: sterile insect technique (TIS); Sterile male Aedes albopictus mosquitos are released in the area/neighborhood
No Intervention: control; Sterile male Aedes albopictus are not released in the area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	12 months
Exposure to Aedes mosquito	self-perceived exposure to mosquito will be assessed by questionnaire	6 months
Exposure to Aedes mosquito	self-perceived exposure to mosquito will be assessed by questionnaire	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protective behavior	a composite indicator derived from a questionnaire will rate the protective behavior of the participants to avoid mosquito bites	6 months
Protective behavior	a composite indicator derived from a questionnaire will rate the protective behavior of the participants to avoid mosquito bites	12 months

Collaborators and Investigators

• Sponsor: Institut de Recherche pour le Developpement

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 2020-A03558-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No