Hookworm Immune Regulation Project

NCT ID: NCT02262403

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Hookworm Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Hookworm infected

The amount, phenotype and function of Treg will be explored at several time points. Cultures with environmental antigen will be subsequently performed.

Group Type EXPERIMENTAL

Blood and feces sampling

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Blood and feces sampling

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université Libre de Bruxelles

OTHER

Sponsor Role collaborator

Brugmann University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Olivier Michel

Head of clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Virginie Doyen, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann - ULB

Locations

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Pham Ngoc Thach University of Medecine

Ho Chi Minh City, Distict 10, Vietnam

Site Status

Countries

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Vietnam

References

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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.

Reference Type BACKGROUND
PMID: 19758373 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17157661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24712468 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23681097 (View on PubMed)

Other Identifiers

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CHUB-HIRP-01

Identifier Type: -

Identifier Source: org_study_id

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