Hookworm Immune Regulation Project

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to characterize the regulatory immune response induced by hookworm in an infected Vietnamese rural population from the periphery of HCM, evolution after infection treatment and during potential naturally reinfection.

Detailed Description
-----------------
Population: 20 healthy adults (18-65 years) infected and non infected by Hookworm will be recruited and treated according to Good Clinical Practice recommendations. Allergy will be excluded by skin prick tests. Amount and phenotype of Treg will be explored at several time points. Subsequent culture with environmental antigen will be performed on cryopreserved cells.

Official Title
-----------------
Study of Immuno-regulatory Mechanisms Induced by Hookworm Infection

Conditions
-----------------
Hookworm Infection

Intervention / Treatment
-----------------
* Other: Blood and feces sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years old adults in good health status To live in rural regions at risk of soil transmitted helminthes Hookworm infection (infected group) Uninfected by Hookworms (control group) Exclusion Criteria: Pregnant woman Positive allergic history Auto-immune and/or HIV disease Antihelminthics drug in the last 6 months and other current parasitic infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hookworm infected<br>The amount, phenotype and function of Treg will be explored at several time points. Cultures with environmental antigen will be subsequently performed. | Other: Blood and feces sampling<br>* Blood and feces samples will be examined after 14 days, 28 days, 3 months and 16 months. This will require blood and feces sampling. The study is therefore defined as 'interventional' rather than 'observational' as it includes acts outside the standard of care.<br>|
| Active Comparator: Non infected (hookworms) healthy subjects<br>All the tests done in the experimental hookworm infected group will be also done in the comparator non infected group. | Other: Blood and feces sampling<br>* Blood and feces samples will be examined after 14 days, 28 days, 3 months and 16 months. This will require blood and feces sampling. The study is therefore defined as 'interventional' rather than 'observational' as it includes acts outside the standard of care.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount and phenotype of Treg | Four colors flow cytometry Treg measurements and phenotyping (FACSCantoII). | 0-12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hookworm, Helminths, Treg, Immune regulation, Vietnam, Allergic diseases