NCT05313126

Brief Summary

This trial is based on 2 complementary components, named ExpAlbo Biomarker and CAPAlbo Questionnaire

  1. 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. 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

January 5, 2022

Last Update Submit

March 28, 2022

Conditions

Mosquito Bite

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Protective behavior

    6 months

  • Protective behavior

    12 months

Study Arms (2)

sterile male Aedes albopictus-exposed

EXPERIMENTAL

Sterile male Aedes albopictus are released in the area.

Other: sterile insect technique (TIS)

control

NO INTERVENTION

Sterile male Aedes albopictus are not released in the area.

Interventions

sterile insect technique (TIS)OTHER

Sterile male Aedes albopictus mosquitos are released in the area/neighborhood

sterile male Aedes albopictus-exposed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

population générale (quartier Duparc (Sainte Marie) et Quartier Bois rouge)

La Réunion, France

RECRUITING

Central Study Contacts

Franck Remoué, PhD

CONTACT

+33 (0)4 67 41 61 30franck.remoue@ird.fr

Jocelyn Raude, PhD

CONTACT

+33 (0)2 99 02 26 15jocelyn.raude@ehesp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A Cluster-Non Randomized Controlled Trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2022

First Posted

April 6, 2022

Study Start

November 9, 2021

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations

FR(1)