Back to resultsHookworm Immune Regulation Project (HIRP-01)
Primary Purpose
Hookworm Infection
Status
Unknown status
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Blood and feces sampling
Sponsored by
About this trial
This is an interventional basic science trial for Hookworm Infection focused on measuring Hookworm, Helminths, Treg, Immune regulation, Vietnam, Allergic diseases
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
Sites / Locations
- Pham Ngoc Thach University of Medecine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hookworm infected
Non infected (hookworms) healthy subjects
Arm Description
The amount, phenotype and function of Treg will be explored at several time points. Cultures with environmental antigen will be subsequently performed.
All the tests done in the experimental hookworm infected group will be also done in the comparator non infected group.
Outcomes
Primary Outcome Measures
Amount and phenotype of Treg
Four colors flow cytometry Treg measurements and phenotyping (FACSCantoII).
Secondary Outcome Measures
Full Information
NCT ID
NCT02262403
First Posted
September 16, 2014
Last Updated
February 18, 2021
Sponsor
Brugmann University Hospital
Collaborators
Université Libre de Bruxelles
1. Study Identification
Unique Protocol Identification Number
NCT02262403
Brief Title
Hookworm Immune Regulation Project
Acronym
HIRP-01
Official Title
Study of Immuno-regulatory Mechanisms Induced by Hookworm Infection
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital
Collaborators
Université Libre de Bruxelles
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hookworm Infection
Keywords
Hookworm, Helminths, Treg, Immune regulation, Vietnam, Allergic diseases
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hookworm infected
Arm Type
Experimental
Arm Description
The amount, phenotype and function of Treg will be explored at several time points. Cultures with environmental antigen will be subsequently performed.
Arm Title
Non infected (hookworms) healthy subjects
Arm Type
Active Comparator
Arm Description
All the tests done in the experimental hookworm infected group will be also done in the comparator non infected group.
Intervention Type
Other
Intervention Name(s)
Blood and feces sampling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Amount and phenotype of Treg
Description
Four colors flow cytometry Treg measurements and phenotyping (FACSCantoII).
Time Frame
0-12 weeks
Other Pre-specified Outcome Measures:
Title
PBMC culture and cryopreservation
Description
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).
Time Frame
after 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginie Doyen, MD
Organizational Affiliation
CHU Brugmann - ULB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pham Ngoc Thach University of Medecine
City
Ho Chi Minh City
State/Province
Distict 10
Country
Vietnam
12. IPD Sharing Statement
Citations:
PubMed Identifier
19758373
Citation
Flohr C, Tuyen LN, Quinnell RJ, Lewis S, Minh TT, Campbell J, Simmons C, Telford G, Brown A, Hien TT, Farrar J, Williams H, Pritchard DI, Britton J. Reduced helminth burden increases allergen skin sensitization but not clinical allergy: a randomized, double-blind, placebo-controlled trial in Vietnam. Clin Exp Allergy. 2010 Jan;40(1):131-42. doi: 10.1111/j.1365-2222.2009.03346.x. Epub 2009 Sep 15.
Results Reference
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PubMed Identifier
17157661
Citation
Flohr C, Tuyen LN, Lewis S, Quinnell R, Minh TT, Liem HT, Campbell J, Pritchard D, Hien TT, Farrar J, Williams H, Britton J. Poor sanitation and helminth infection protect against skin sensitization in Vietnamese children: A cross-sectional study. J Allergy Clin Immunol. 2006 Dec;118(6):1305-11. doi: 10.1016/j.jaci.2006.08.035. Epub 2006 Oct 13.
Results Reference
background
PubMed Identifier
24712468
Citation
Finlay CM, Walsh KP, Mills KH. Induction of regulatory cells by helminth parasites: exploitation for the treatment of inflammatory diseases. Immunol Rev. 2014 May;259(1):206-30. doi: 10.1111/imr.12164.
Results Reference
background
PubMed Identifier
23681097
Citation
Sakaguchi S, Vignali DA, Rudensky AY, Niec RE, Waldmann H. The plasticity and stability of regulatory T cells. Nat Rev Immunol. 2013 Jun;13(6):461-7. doi: 10.1038/nri3464. Epub 2013 May 17.
Results Reference
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Hookworm Immune Regulation Project
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