Hookworm Immune Regulation Project (HIRP-01)

February 18, 2021 updated by: Olivier Michel, Brugmann University Hospital

Study of Immuno-regulatory Mechanisms Induced by Hookworm Infection

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Distict 10
      • Ho Chi Minh City, Distict 10, Vietnam
        • Pham Ngoc Thach University of Medecine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
PBMC culture and cryopreservation
Time Frame: 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).
after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brugmann University Hospital

Collaborators

Université Libre de Bruxelles

Investigators

  • Principal Investigator: Virginie Doyen, MD, CHU Brugmann - ULB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUB-HIRP-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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