Hookworm Immune Regulation Project (HIRP-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02262403
Recruitment Status : Active, not recruiting
First Posted : October 13, 2014
Last Update Posted : January 26, 2018
Université Libre de Bruxelles
Information provided by (Responsible Party):
Olivier Michel, Brugmann University Hospital

September 16, 2014
October 13, 2014
January 26, 2018
August 1, 2014
December 2018   (Final data collection date for primary outcome measure)
Amount and phenotype of Treg [ Time Frame: 0-12 weeks ]
Four colors flow cytometry Treg measurements and phenotyping (FACSCantoII).
Same as current
Complete list of historical versions of study NCT02262403 on Archive Site
Not Provided
Not Provided
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).
Same as current
Hookworm Immune Regulation Project
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.

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.

Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Hookworm Infection
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.
  • 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.
    Intervention: Other: Blood and feces sampling
  • 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.
    Intervention: Other: Blood and feces sampling

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
December 2018
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Olivier Michel, Brugmann University Hospital
Brugmann University Hospital
Université Libre de Bruxelles
Principal Investigator: Virginie Doyen, MD CHU Brugmann - ULB
Brugmann University Hospital
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP