Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-28 @ 4:16 PM
Study NCT ID:
NCT00389103
Status:
WITHDRAWN
Last Update Posted:
2014-01-22
First Post:
2006-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012899', 'term': 'Smallpox'}, {'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D011213', 'term': 'Poxviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C527606', 'term': 'smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Senior management decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-17', 'studyFirstSubmitDate': '2006-10-16', 'studyFirstSubmitQcDate': '2006-10-17', 'lastUpdatePostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'Study Completion'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity', 'timeFrame': 'Study Completion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Smallpox', 'Atopic Dermatitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with a history of mild to moderate Atopic Dermatitis.', 'detailedDescription': "This is a randomized, double-blind, placebo-controlled study. subjects will be randomized to receive investigational vaccine or placebo at a ratio of 3.5:1, MVA3000 to placebo. All subjects will undergo a screening period, a treatment/observation period during which all subjects will receive injections on study day 0 and study day 28 of investigational vaccine or placebo. The clinical observation period will be completed at day 56. A visit will occur at approximately 3 months after the second study injection (study day 118) for additional blood collection and a review of the subject's health status. Follow-up will be obtained via telephone contacts approximately 6 months after the end of the second injection during the treatment/observation period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults at least 18 years old and who were born after 1971 with no previous history of smallpox vaccination\n* Subjects must be in good general health Female subjects must not be pregnant or lactating and must agree to practice birth control during the course of the study\n* Subjects must have a diagnosis of AD by an experienced clinician that includes a history of both major and minor diagnostic criteria\n* At the time of screening, the subject must have "mild to moderate" AD.\n\nExclusion Criteria:\n\n* History or evidence of prior exposure to a vaccinia or MVA- containing product\n* known or suspected history of immunodeficiency other than AD\n* Known or suspected impairment of major organ function\n* Known history or diagnosis of cardiac disease or cerebrovascular disease\n* presence of acute, chronic, or active exfoliative skin conditions other than AD, open wounds, or burns.\n* Dementia or history of seizures\n* Known allergies to MVA or any known components of the vaccine\n* transfusion of blood, organ transplantation, or treatment with any blood product\n* morbid obesity, or a BMI less than or equal to 18.5\n* history of or current drug or alcohol abuse (except nicotine) within the past 6 months or any history of IV drug use\n* history of major psychiatric illness except major depression not requiring medical therapy.\n* subjects who have participated in another investigational drug or vaccine trial within 30 days of study day 0'}, 'identificationModule': {'nctId': 'NCT00389103', 'briefTitle': 'Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase 1, Placebo-Controlled, Double-Blind Study of the Safety and Immunogenicity of Two Injections of MVA3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Vaccinia Naive Adult Subjects With a History of Atopic Dermatitis (AD)', 'orgStudyIdInfo': {'id': 'H-249-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Biological: MVA (smallpox vaccine)']}], 'interventions': [{'name': 'MVA (smallpox vaccine)', 'type': 'BIOLOGICAL', 'otherNames': ['placebo'], 'description': '0.5ml of MVA3000 Smallpox vaccine, administered twice separated by 28 days, subcutaneous injections', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Academic Dermatology Associates', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'DermResearch, Inc.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}