Clinical trial NCT02262403: Hookworm Immune Regulation Project
Official title: Study of Immuno-regulatory Mechanisms Induced by Hookworm Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hookworm Infection
Keywords: Hookworm
Helminths
Treg
Immune regulation
Vietnam
Allergic diseases
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
Collaborators: name: Université Libre de Bruxelles
First posted: 2014-10-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Amount and phenotype of Treg
timeFrame: 0-12 weeks
Secondary outcomes:
Other outcomes:
measure: PBMC culture and cryopreservation
timeFrame: after 12 weeks
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Pham Ngoc Thach University of Medecine
state: Distict 10
Study officials:
affiliation: CHU Brugmann - ULB
name: Virginie Doyen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.