Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT02825368
Status:
UNKNOWN
Last Update Posted:
2017-08-04
First Post:
2016-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Homeopathic Vaccine Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'lastUpdateSubmitDate': '2017-08-03', 'studyFirstSubmitDate': '2016-06-24', 'studyFirstSubmitQcDate': '2016-07-04', 'lastUpdatePostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody levels for diphtheria', 'timeFrame': '3 weeks'}, {'measure': 'Antibody levels for pertussis', 'timeFrame': '3 weeks'}, {'measure': 'Antibody levels for tetanus', 'timeFrame': '3 weeks'}, {'measure': 'Antibody levels for mumps', 'timeFrame': '3 weeks'}, {'measure': 'Antibody levels for measles', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the immunological response of homeopathic vaccines to placebo and to conventional vaccines in healthy young adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18 and 24 years\n* Has received primary childhood DTaP and MMR vaccinations\n* Available for a follow up visit (3 weeks after initial visit)\n\nExclusion Criteria:\n\n* Received a live vaccine in the past 4 weeks\n* Has had a serious allergic reaction to a previous vaccination\n* Has allergies to one or more of the components of the vaccines to be used (Neomycin, egg protein)\n* Has a history of encephalopathy within 7 days of receiving DTP/DTap\n* Has received nosodes for Diphtheria, Tetanus, Pertussis, Measles and Mumps\n* Has received an adult booster dose of conventional vaccines of diphtheria, pertussis, tetanus, mumps, and measles (Tdap or MMR)\n* Has received immunosuppressive doses of steroids or anti-cancer drugs in the past 3 months\n* Is pregnant or if there is a chance they could become pregnant during the next month\n* Has a moderate to severe acute illness at the time of enrolment\n* Has cancer, leukemia, HIV/AIDS, or any other serious immune health condition\n* Has a history of Guillaume Barre Syndrome\n* Has received blood transfusion, blood products, or immune globulin within the past year'}, 'identificationModule': {'nctId': 'NCT02825368', 'acronym': 'HVT', 'briefTitle': 'Homeopathic Vaccine Trial', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Homeopathic Vaccine Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HVT-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Homeopathic vaccine group', 'description': '* Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes.\n* Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo.', 'interventionNames': ['Other: Diphtherinum®', 'Other: Pertussinum®', 'Other: Tetanotxicum®', 'Other: Morbilinum®', 'Other: Ourlianum®', 'Other: Sterile saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional vaccine group', 'description': '* One intramuscular dose of Tdap (tetanus, diphtheria, acellular pertussis)\n* One subcutaneous dose of MMR (measles, mumps, rubella)\n* Sugar pellets as placebo.', 'interventionNames': ['Biological: MMR', 'Biological: Tdap', 'Other: Sugar pellets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': '* Sugar pellets oral dose\n* Two sterile saline injections (0.5 ml each, intramuscular and subcutaneous) as placebo', 'interventionNames': ['Other: Sterile saline', 'Other: Sugar pellets']}], 'interventions': [{'name': 'MMR', 'type': 'BIOLOGICAL', 'description': '0.5 mL, subcutaneous', 'armGroupLabels': ['Conventional vaccine group']}, {'name': 'Tdap', 'type': 'BIOLOGICAL', 'description': '0.5 mL, intramuscular', 'armGroupLabels': ['Conventional vaccine group']}, {'name': 'Diphtherinum®', 'type': 'OTHER', 'armGroupLabels': ['Homeopathic vaccine group']}, {'name': 'Pertussinum®', 'type': 'OTHER', 'armGroupLabels': ['Homeopathic vaccine group']}, {'name': 'Tetanotxicum®', 'type': 'OTHER', 'armGroupLabels': ['Homeopathic vaccine group']}, {'name': 'Morbilinum®', 'type': 'OTHER', 'armGroupLabels': ['Homeopathic vaccine group']}, {'name': 'Ourlianum®', 'type': 'OTHER', 'armGroupLabels': ['Homeopathic vaccine group']}, {'name': 'Sterile saline', 'type': 'OTHER', 'description': '0.5 mL, intramuscular', 'armGroupLabels': ['Control group', 'Homeopathic vaccine group']}, {'name': 'Sugar pellets', 'type': 'OTHER', 'armGroupLabels': ['Control group', 'Conventional vaccine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8S 4K1', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mark B Loeb, MD, MSc', 'role': 'CONTACT', 'email': 'loebm@mcmaster.ca', 'phone': '905-525-9140', 'phoneExt': '26066'}, {'name': 'Sasha Eskandarian, MSc', 'role': 'CONTACT', 'email': 'eskand@mcmaster.ca', 'phone': '905-525-9140', 'phoneExt': '26672'}, {'name': 'Mark B Loeb, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Mark Loeb, MD, MSc.', 'role': 'CONTACT', 'email': 'loebm@mcmaster.ca', 'phone': '905-525-9140', 'phoneExt': '26066'}, {'name': 'Sasha Eskandarian, MSc', 'role': 'CONTACT', 'email': 'eskand@mcmaster.ca', 'phone': '905-525-9140', 'phoneExt': '26672'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}