HIRP-01: Hookworm Immune Regulation Project

Sponsor

Brugmann University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02262403

Collaborator

Université Libre de Bruxelles (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hookworm Infection	Other: Blood and feces sampling	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Study of Immuno-regulatory Mechanisms Induced by Hookworm Infection

Actual Study Start Date :

Aug 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hookworm infected 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 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.
Active Comparator: Non infected (hookworms) healthy subjects 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 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.

Arm

Intervention/Treatment

Experimental: Hookworm infected

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

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.

Active Comparator: Non infected (hookworms) healthy subjects

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

Outcome Measures

Primary Outcome Measures

Amount and phenotype of Treg [0-12 weeks]
Four colors flow cytometry Treg measurements and phenotyping (FACSCantoII).

Other Outcome Measures

PBMC culture and cryopreservation [after 12 weeks]
Assessment of the orientation of the adaptative immune response to Dermatophagoides pteronyssinus.Subsequent Treg function testing and cell cultures (with environmental antigen) on cryopreserved PBMC (Peripheral Blood Mononuclear cells).