Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT00189956
Status:
COMPLETED
Last Update Posted:
2019-01-10
First Post:
2005-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose-finding Study to Evaluate Immunogenicity of Three Different Dose Levels of the IMVAMUNE (MVA-BN) Smallpox Vaccine.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C527606', 'term': 'smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-08', 'studyFirstSubmitDate': '2005-09-11', 'studyFirstSubmitQcDate': '2005-09-11', 'lastUpdatePostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ELISA seroconversion rate', 'timeFrame': 'Day 42', 'description': 'Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.'}], 'secondaryOutcomes': [{'measure': 'ELISA seroconversion rate', 'timeFrame': 'Days 28, 84', 'description': 'Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.'}, {'measure': 'ELISA GMT', 'timeFrame': 'Days 28, 42, 84', 'description': "Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'."}, {'measure': 'PRNT seroconversion rate', 'timeFrame': 'Days 28, 42, 84', 'description': 'Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.'}, {'measure': 'PRNT GMT', 'timeFrame': 'Days 28, 42, 84', 'description': "Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'."}, {'measure': 'Cytotoxic T-Lymphocyte response', 'timeFrame': 'Days 28, 42, 84', 'description': 'The Cytotoxic T-Lymphocyte (CTL) response was determined by measuring IFNγ producing cells by Intracellular cytokine staining (ICS)'}, {'measure': 'Serious Adverse Events', 'timeFrame': 'within 12 weeks', 'description': 'Incidence, relationship and intensity of any Serious Adverse Event (SAE)'}, {'measure': 'Solicited Local Adverse Events', 'timeFrame': 'within 8 days after any vaccination', 'description': 'Incidence and intensity of solicited local AEs. Percentages based on subjects with at least one completed diary card.'}, {'measure': 'Solicited General Adverse Events', 'timeFrame': 'within 8 days after any vaccination', 'description': 'Incidence of solicited general AEs: Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.'}, {'measure': 'Unsolicited Non-serious Adverse Events', 'timeFrame': 'within 31 days after any vaccination', 'description': 'Occurrence of unsolicited non-serious AEs: Intensity and relationship to vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Smallpox']}, 'referencesModule': {'references': [{'pmid': '19944151', 'type': 'RESULT', 'citation': 'von Krempelhuber A, Vollmar J, Pokorny R, Rapp P, Wulff N, Petzold B, Handley A, Mateo L, Siersbol H, Kollaritsch H, Chaplin P. A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE. Vaccine. 2010 Feb 3;28(5):1209-16. doi: 10.1016/j.vaccine.2009.11.030. Epub 2009 Nov 25.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to find the optimal dose for the smallpox candidate vaccine IMVAMUNE (MVA-BN). For this purpose the study compares IMVAMUNE (MVA-BN) administered at three different dose levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female subjects, aged 18 - 30 years\n* Signed informed consent after being advised of the risks and benefits of the study in a language able to understand, and prior to performance of any study specific procedure.\n* Free of obvious health problems with acceptable medical history by screening evaluation and physical examination.\n* Subject of not of child-bearing potential or all of the following: A urine/serum ß-HCG pregnancy test gives a negative result, use of adequate contraceptive precautions for 30 days before first vaccination.\n\nExclusion Criteria:\n\n* Known or suspected history of smallpox vaccination or typical vaccinia scar.\n* Positive test result in MVA specific ELISA or PRNT at screening.\n* Positive result in HIV or HCV antibody test at screening.\n* HbsAG positive at screening.\n* Pregnancy or breast-feeding.\n* Uncontrolled serious infection i.e. not responding to antimicrobial therapy\n* History of any serious medical condition, which in the opinion of the investigator, would compromise the safety of the subject.\n* History of autoimmune disease\n* History of malignancy.\n* History of chronic alcohol abuse and/or intravenous drug abuse.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.\n* History of anaphylaxis or severe allergic reaction.\n* Acute disease (a moderate or severe illness with or without a fever) at the time of enrolment.\n* Any vaccinations within a period starting 30 days prior to administration of the vaccine and ending at study conclusion.\n* Chronic administration of immuno-suppressants or other immune-modifying drugs.\n* Administration or planned administration of immunoglobulins and/or any blood products during the study period.\n* Use of any investigational or non-registered drug or vaccine.'}, 'identificationModule': {'nctId': 'NCT00189956', 'briefTitle': 'Dose-finding Study to Evaluate Immunogenicity of Three Different Dose Levels of the IMVAMUNE (MVA-BN) Smallpox Vaccine.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bavarian Nordic'}, 'officialTitle': 'Phase II, Double-blind, Randomised, Dose-finding Study to Evaluate the Immunogenicity of Three Different Doses of MVA-BN Smallpox Vaccine in 18-30 Year Old Smallpox naïve Healthy Subjects', 'orgStudyIdInfo': {'id': 'POX-MVA-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'healthy, vaccinia naïve subjects 2 x 10E7 TCID50 IMVAMUNE (MVA-BN), subcutaneous', 'interventionNames': ['Biological: IMVAMUNE (MVA-BN)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'healthy, vaccinia naïve subjects 5 x 10E7 TCID50 IMVAMUNE (MVA-BN), subcutaneous', 'interventionNames': ['Biological: IMVAMUNE (MVA-BN)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'healthy, vaccinia naïve subjects\n\n1 x 10E8 TCID50 IMVAMUNE (MVA-BN), subcutaneous', 'interventionNames': ['Biological: IMVAMUNE (MVA-BN)']}], 'interventions': [{'name': 'IMVAMUNE (MVA-BN)', 'type': 'BIOLOGICAL', 'description': 'Two vaccinations of 0.5 ml MVA-BN vaccine, separated by a 4 week interval.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4123', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Swiss Pharma Contract', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Rolf Pokorny, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swiss Pharma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bavarian Nordic', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}