ClinicalTrials.gg
Status unknownNCT02262403HIRP-01Updated Feb 21, 2021

Hookworm Immune Regulation Project

An interventional study of Blood and feces sampling in Hookworm Infection, sponsored by Brugmann University Hospital. Status unknown at 1 site in Vietnam. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-02-21.

Sponsored by Brugmann University Hospital · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hookworm Infection

Keywords

  • Hookworm
  • Helminths
  • Treg
  • Immune regulation
  • Vietnam
  • Allergic diseases
03

In context

Hookworm Infections

39 studies on the registry are indexed under Hookworm Infections; 5 are open to participants now.

This study's enrollment of 40 is below the median of 182 across 36 interventional studies indexed under Hookworm Infections.

Browse Hookworm Infections studies →

Lead sponsor

Brugmann University Hospital is the lead sponsor of 117 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Pregnant woman
  • Positive allergic history
  • Auto-immune and/or disease
  • Antihelminthics drug in the last 6 months and other current parasitic infection
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherBlood 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.

06

What researchers measure

Primary outcomes

  1. Amount and phenotype of Treg

    Four colors flow cytometry Treg measurements and phenotyping (FACSCantoII).

    Time frame: 0-12 weeks

Other outcomes

  1. PBMC culture and cryopreservation

    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

07

Study locations

1 site
  • Pham Ngoc Thach University of Medecine
    Ho Chi Minh City, Distict 10, Vietnam
08

References and documents

Publications

  • 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. PubMed 19758373 ↗
  • 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. PubMed 17157661 ↗
  • 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. PubMed 24712468 ↗
  • 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. PubMed 23681097 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02262403
Collaborators
Université Libre de Bruxelles
Responsible party
Olivier Michel (Head of clinic, Brugmann University Hospital) — Principal investigator
First posted
Oct 13, 2014
Start date
Aug 1, 2014
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Feb 21, 2021

Study contacts

Virginie Doyen, MD
principal investigator · CHU Brugmann - ULB

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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