Hookworm Immune Regulation Project

Hookworm Infection Clinical Trial

— HIRP-01  

Official title:

Study of Immuno-regulatory Mechanisms Induced by Hookworm Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02262403
• Other study ID #: CHUB-HIRP-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2014
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hookworm Infection
• Hookworm Infections
• Infection

Intervention

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.

Locations

Country	Name	City	State
Vietnam	Pham Ngoc Thach University of Medecine	Ho Chi Minh City	Distict 10

Sponsors (2)

Lead Sponsor	Collaborator
Brugmann University Hospital	Université Libre de Bruxelles

Country where clinical trial is conducted

Vietnam, 

References & Publications (4)

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. Review. — View 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. Epub 2006 Oct 13. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	after 12 weeks
Primary	Amount and phenotype of Treg	Four colors flow cytometry Treg measurements and phenotyping (FACSCantoII).	0-12 weeks