Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT00189969
Status:
COMPLETED
Last Update Posted:
2006-04-21
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Take Rate, Immunogenicity and Safety of Elstree-BN Smallpox Vaccine in Healthy Vaccinia-Naive Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012899', 'term': 'Smallpox'}], 'ancestors': [{'id': 'D011213', 'term': 'Poxviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-04', 'completionDateStruct': {'date': '2006-02'}, 'lastUpdateSubmitDate': '2006-04-20', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2006-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of a typical pock ("take") which is associated historically with protection against variola within one week after vaccination.'}], 'secondaryOutcomes': [{'measure': 'Occurrence, relationship and intensity of any serious adverse event at any time during the study / any non-serious adverse event within 4 weeks after vaccination.'}, {'measure': 'ELISA / Neutralisation assay specific seroconversion rates and geometric mean titres 2,4,12,52 and 104 weeks after vaccination.'}, {'measure': 'Interferone-gamma producing T cells 2,4,12,52 and 104 weeks after vaccination.'}]}, 'conditionsModule': {'conditions': ['Smallpox']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the take rate (formation of a typical postvaccinal lesion)and the safety and immunogenicity of the smallpox vaccine Elstree-BN.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '32 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Free of obvious health problems\n* Negative HIV test\n* Negative hepatitis B surface antigen and negative antibody to hepatitis C virus\n* Hematocrit ≥ 38%; white blood cells between 4.0 and 10.0 / nl with differential blood count without clinical finding; and platelets between 150 and 400 / nl\n* ALT \\< 1.5 times institutional upper limit of normal\n* Negative urine glucose by dipstick or urinalysis\n* Adequate renal function defined as a serum creatinine \\< 1.5 mg/dL; urine protein \\< 100 mg/dL or \\< 2+ proteinuria; and a calculated creatinine clearance \\> 55 mL/min.\n* For women, negative pregnancy test at screening and within 24 hours prior to vaccination.\n* If the volunteer is female and of childbearing potential, she agrees to use acceptable contraception.\n\nExclusion Criteria:\n\n* Pregnancy or breast-feeding\n* Known or suspected history of smallpox vaccination\n* Typical vaccinia scar\n* Vaccinia specific antibodies at screening\n* History of immunodeficiency\n* Known or suspected impairment of immunologic function\n* Use of immunosuppressive medication or radiation therapy\n* Any history of atopic disease\n* Eczema of any degree or history of eczema\n* Chronic exfoliative skin disorders/conditions or any acute skin disorders of large magnitude\n* Any malignancy including leukemia or lymphoma\n* Presence of any infectious disease or a history or evidence of autoimmune disease\n* History or clinical manifestation of clinically significant mental illness or haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders\n* History of drug or chemical abuse\n* Administration of inactivated vaccine 14 days prior to vaccination\n* Any immune modifying therapy within 4 weeks prior to vaccination\n* Administration of live attenuated vaccines within 60 days prior to vaccination\n* Receipt of blood products or immunoglobulin in the past 6 months\n* Subjects with acute febrile illness within one week prior to vaccination or subjects who may be in the incubation period of an infectious disease\n* Household contacts/sexual contacts with, or occupational exposure to any of the following:\n\n 1. Pregnant women\n 2. Children \\<12 months of age\n 3. People with current or history of atopic dermatitis\n 4. People with chronic exfoliative skin disorders/conditions or any acute skin disorders\n 5. People with immunodeficiency disease, malignancies or use of immunosuppressive medications\n* History of anaphylaxis or severe allergic reaction\n* Hypersensitivity to egg or chick protein\n* Known allergies to any component of the vaccine or its diluent\n* Known allergies to any known component of VIG\n* Known allergies to cidofovir or probenecid\n* Abnormalities suggestive of any underlying disease, detected at routine tests prior to study inclusion\n* Use of any investigational or non-registered drug or vaccine starting 30 days preceding the study vaccine and ending at conclusion visit\n* History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or other heart condition under the care of a doctor.\n* Three or more of the following risk factors: An immediate family member who has had onset of ischemic heart disease before age 50 years, elevated blood pressure, elevated blood cholesterol, diabetes or nicotine abuse.'}, 'identificationModule': {'nctId': 'NCT00189969', 'briefTitle': 'Take Rate, Immunogenicity and Safety of Elstree-BN Smallpox Vaccine in Healthy Vaccinia-Naive Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bavarian Nordic'}, 'officialTitle': "Phase I Study to Evaluate Take Rate, Immunogenicity and Safety of Bavarian Nordic's Smallpox Vaccine Elstree-BN Administered to Healthy Vaccinia-Naive Subjects in the Age of 18-32 Years", 'orgStudyIdInfo': {'id': 'POX-ELS-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Elstree-BN', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'state': 'Nordrhein', 'country': 'Germany', 'facility': 'Focus Clinical Drug Development GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Andreas Schroedter, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Focus Clinical Drug Development GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bavarian Nordic', 'class': 'INDUSTRY'}}}}