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Hookworm Immune Regulation Project (HIRP-01)

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ClinicalTrials.gov Identifier: NCT02262403
Recruitment Status : Active, not recruiting
First Posted : October 13, 2014
Last Update Posted : July 26, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
Hookworm Infection Other: Blood and feces sampling

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  (Clinical Trial)
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
Study Start Date : August 2014
Primary Completion Date : March 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.


Outcome Measures

Primary Outcome Measures :
  1. Amount and phenotype of Treg [ Time Frame: 0-12 weeks ]
    Four colors flow cytometry Treg measurements and phenotyping (FACSCantoII).


Other Outcome Measures:
  1. 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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262403


Locations
Vietnam
Pham Ngoc Thach University of Medecine
Ho Chi Minh City, Distict 10, Vietnam
Sponsors and Collaborators
Brugmann University Hospital
Université Libre de Bruxelles
Investigators
Principal Investigator: Virginie Doyen, MD CHU Brugmann - ULB
More Information

Publications:
Responsible Party: Olivier Michel, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02262403     History of Changes
Other Study ID Numbers: CHUB-HIRP-01
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by Olivier Michel, Brugmann University Hospital:
Hookworm
Helminths
Treg
Immune regulation
Vietnam
Allergic diseases

Additional relevant MeSH terms:
Infection
Hookworm Infections
Ancylostomiasis
Strongylida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases