Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-03-03 @ 2:20 AM
Study NCT ID:
NCT02262403
Status:
UNKNOWN
Last Update Posted:
2021-02-21
First Post:
2014-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hookworm Immune Regulation Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006725', 'term': 'Hookworm Infections'}, {'id': 'D000724', 'term': 'Ancylostomiasis'}], 'ancestors': [{'id': 'D017206', 'term': 'Strongylida Infections'}, {'id': 'D017190', 'term': 'Secernentea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2014-09-16', 'studyFirstSubmitQcDate': '2014-10-08', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'PBMC culture and cryopreservation', 'timeFrame': 'after 12 weeks', 'description': '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).'}], 'primaryOutcomes': [{'measure': 'Amount and phenotype of Treg', 'timeFrame': '0-12 weeks', 'description': 'Four colors flow cytometry Treg measurements and phenotyping (FACSCantoII).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hookworm', 'Helminths', 'Treg', 'Immune regulation', 'Vietnam', 'Allergic diseases'], 'conditions': ['Hookworm Infection']}, 'referencesModule': {'references': [{'pmid': '19758373', 'type': 'BACKGROUND', '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.'}, {'pmid': '17157661', 'type': 'BACKGROUND', '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.'}, {'pmid': '24712468', 'type': 'BACKGROUND', '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.'}, {'pmid': '23681097', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Population: 20 healthy adults (18-65 years) infected and non infected by Hookworm will be recruited and treated according to Good Clinical Practice recommendations.\n\nAllergy 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years old adults in good health status\n* To live in rural regions at risk of soil transmitted helminthes\n* Hookworm infection (infected group)\n* Uninfected by Hookworms (control group)\n\nExclusion Criteria:\n\n* Pregnant woman\n* Positive allergic history\n* Auto-immune and/or HIV disease\n* Antihelminthics drug in the last 6 months and other current parasitic infection'}, 'identificationModule': {'nctId': 'NCT02262403', 'acronym': 'HIRP-01', 'briefTitle': 'Hookworm Immune Regulation Project', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'Study of Immuno-regulatory Mechanisms Induced by Hookworm Infection', 'orgStudyIdInfo': {'id': 'CHUB-HIRP-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hookworm infected', 'description': 'The amount, phenotype and function of Treg will be explored at several time points. Cultures with environmental antigen will be subsequently performed.', 'interventionNames': ['Other: Blood and feces sampling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non infected (hookworms) healthy subjects', 'description': 'All the tests done in the experimental hookworm infected group will be also done in the comparator non infected group.', 'interventionNames': ['Other: Blood and feces sampling']}], 'interventions': [{'name': 'Blood and feces sampling', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Hookworm infected', 'Non infected (hookworms) healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ho Chi Minh City', 'state': 'Distict 10', 'country': 'Vietnam', 'facility': 'Pham Ngoc Thach University of Medecine', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Virginie Doyen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Brugmann - ULB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brugmann University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Libre de Bruxelles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of clinic', 'investigatorFullName': 'Olivier Michel', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}