NCT02262403

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

7.3 years

First QC Date

September 16, 2014

Last Update Submit

February 18, 2021

Conditions

Hookworm Infection

Keywords

HookwormHelminthsTregImmune regulationVietnamAllergic diseases

Outcome Measures

Primary Outcomes (1)

  • Amount and phenotype of Treg

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

    0-12 weeks

Other Outcomes (1)

  • PBMC culture and cryopreservation

    after 12 weeks

Study Arms (2)

Hookworm infected

EXPERIMENTAL

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

Non infected (hookworms) healthy subjects

ACTIVE COMPARATOR

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

Blood and feces samplingOTHER

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.

Hookworm infectedNon infected (hookworms) healthy subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Pregnant woman
  • Positive allergic history
  • Auto-immune and/or HIV disease
  • Antihelminthics drug in the last 6 months and other current parasitic infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pham Ngoc Thach University of Medecine

Ho Chi Minh City, Distict 10, Vietnam

Location

Related Publications (4)

  • 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.

    PMID: 19758373BACKGROUND

  • 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.

    PMID: 17157661BACKGROUND

  • 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.

    PMID: 24712468BACKGROUND

  • 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.

    PMID: 23681097BACKGROUND

MeSH Terms

Conditions

Hookworm InfectionsAncylostomiasis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Strongylida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfections

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Virginie Doyen, MD

    CHU Brugmann - ULB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

September 16, 2014

First Posted

October 13, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

VN(1)