Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-01 @ 9:14 PM
Study NCT ID:
NCT01158157
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2010-07-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000588544', 'term': 'ACAM2000'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chall@ebsi.com', 'phone': '204-275-4248', 'title': 'Christine Hall, Ph.D. Director Clinical', 'organization': 'Cangene Corporation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year, 6 months', 'description': 'AE: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.', 'eventGroups': [{'id': 'EG000', 'title': 'ACAM200 Vaccination Dose', 'description': 'Participants received a single percutaneous administration of a droplet (2.5 μL) of the ACAM2000 smallpox vaccine using a bifurcated needle on Day 0.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 15, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site scab', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaccination complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACAM200 Vaccination Dose', 'description': 'Participants received a single percutaneous administration of a droplet (2.5 μL) of the ACAM2000 smallpox vaccine using a bifurcated needle on Day 0.'}], 'classes': [{'title': 'Vaccination complications', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'injection site scab', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 to 90 post-vaccination', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Post-vaccination adverse events were assessed in the safety population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vaccination', 'description': 'This study was a single arm study. All eligible subjects received ACAM2000.\n\nACAM2000: Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '61 subjects screened; 25 subjects were vaccinated; 36 subjects were not eligible.', 'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Vaccination', 'description': 'This study was a single arm study. All eligible subjects received ACAM2000.\n\nACAM2000: Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age', 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '9.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'A total of 61 subjects were screened for VA-006 study; 25 subjects satisfied the eligibility criteria and were percutaneously administered ACAM2000 vaccine, while 36 subjects were not eligible for the study and were not administered ACAM2000.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2012-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2010-07-05', 'resultsFirstSubmitDate': '2017-06-07', 'studyFirstSubmitQcDate': '2010-07-06', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-01', 'studyFirstPostDateStruct': {'date': '2010-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration', 'timeFrame': 'Days 0 to 90 post-vaccination'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smallpox Vaccine Adverse Reaction']}, 'referencesModule': {'references': [{'pmid': '10458959', 'type': 'BACKGROUND', 'citation': 'Russell PK. Vaccines in civilian defense against bioterrorism. Emerg Infect Dis. 1999 Jul-Aug;5(4):531-3. doi: 10.3201/eid0504.990413. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://whqlibdoc.who.int/wer/WHO_WER_1980/WER1980_55_145-152%20(N%C2%B020).pdf', 'label': 'World Health Organization. Declaration of global eradication of smallpox. Wkly. Epidemiol. Rec., 55:145-152, 1980.'}, {'url': 'http://www.cdc.gov/mmwr/', 'label': 'Centers for Disease Control and Prevention (CDC). Public Health Service recommendations on smallpox vaccination. MMWR, 20:339, 1971.'}, {'url': 'http://www.cdc.gov/mmwr/', 'label': 'CDC. Recommendation of the Immunization Practices Advisory Committee (ACIP). Smallpox vaccination of hospital and health personnel. MMWR, 25:9, 1976.'}, {'url': 'http://www.cdc.gov/mmwr/', 'label': 'CDC. Smallpox vaccine no longer available for civilians-United States. MMWR, 32:387, 1983.'}, {'url': 'http://www.cdc.gov/mmwr/', 'label': 'CDC. Vaccinia (smallpox) vaccine recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR, 40:1-10, 1991.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to vaccinate plasma donors with ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed written informed consent.\n* Age 18 - 65 years.\n* Normal and healthy as determined by medical history, physical exam, vital signs and clinical laboratory tests at screening visit.\n* Subject must meet all required subject suitability criteria that pertain to normal Source Plasma donors.\n* Subject must have been previously immunized for smallpox, at ≥1 year prior to commencement of screening assessments for the VA-006 trial, and vaccination history must be confirmed by oral or written history AND the presence of a visible pathognomonic smallpox vaccination scar.\n* Female subjects of childbearing potential must use at least one of the following means of birth control documented by a physician's letter:\n\n * Surgical sterilization\n * Hormonal (oral/injectable/implant) for at least 30 days prior to vaccination\n * Intrauterine device (IUD) inserted at least 7 days prior to vaccination.\n* Female subjects who are not using one of the methods of birth control listed above must be documented as postmenopausal, which is defined as not having a menstrual period for longer than 12 months and having a serum follicle-stimulating hormone (FSH) level ≥ 40 mIU/mL.\n\nExclusion Criteria:\n\n* History of severe adverse event(s) from previous participation in the VA-001 or VA-005 trials or any other smallpox vaccination program/study.\n* Subject, household contact, or other close/intimate contact:\n\n * with eczema, history of eczema, exfoliative skin conditions, wounds, burns, or other skin conditions at the Investigator's discretion.\n * with a history of immunodeficiencies (see section 7.1.2 of the protocol).\n * who received radiotherapy or chemotherapy, adrenocorticotropic hormone (ACTH), corticosteroids, or immunosuppressive drugs.\n * with eye disease treated with topical steroids.\n * with known or suspected disorders of immunoglobulin synthesis.\n * with leukemia, lymphomas of any type, melanoma, or other malignant neoplasms affecting the bone marrow or lymphatic systems.\n * with a history of adverse reactions to smallpox (vaccinia) vaccine.\n * has recently been diagnosed with cancer and who will be undergoing chemotherapy or radiation therapy during the vaccination healing time.\n * is a transplant recipient (except for corneal transplant).\n * is pregnant, planning pregnancy or breast feeding (female subjects must have negative serum pregnancy test at screening and negative urine pregnancy test prior to vaccination).\n* Household or other close/intimate contact(s) under the age of 12 months.\n* History of allergies to latex, phenol, any of the antibiotics listed in the vaccine content, or any other component of ACAM2000 or its diluent\n* Severely or morbidly obese or higher obesity classification (BMI ≥ 35).\n* Subjects with abnormal EKG and/or cardiac Troponin levels at screening.\n* Subjects with cancer or kidney disease (except kidney stones).\n* Subject has 3 or more of the following risk factors:\n\n * High blood pressure diagnosed by a doctor\n * High blood cholesterol diagnosed by a doctor\n * Diabetes or high blood sugar diagnosed by a doctor\n * A first degree relative (for example, mother, father, brother, sister) who had a heart condition before the age of 50\n * Currently smokes cigarettes\n* Cardiovascular disease or heart condition diagnosed by a doctor at any time in the past, with or without symptoms, including:\n\n * Arrhythmia\n * Syncope\n * Previous myocardial infarction\n * Angina\n * Coronary artery disease\n * Congestive heart failure\n * Cardiomyopathy\n * Stroke or transient ischemic attack\n * Chest pain or shortness of breath with activity (such as walking up stairs)\n * Other heart conditions being treated by a physician."}, 'identificationModule': {'nctId': 'NCT01158157', 'briefTitle': 'VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV', 'organization': {'class': 'INDUSTRY', 'fullName': 'Emergent BioSolutions'}, 'officialTitle': 'Vaccinia Vaccine (ACAM2000) for the Production of Vaccinia Immune Globulin Intravenous (VIGIV)', 'orgStudyIdInfo': {'id': 'VA-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Vaccination', 'description': 'This study was a single arm study. All eligible subjects received ACAM2000.', 'interventionNames': ['Biological: ACAM2000']}], 'interventions': [{'name': 'ACAM2000', 'type': 'BIOLOGICAL', 'description': 'Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.', 'armGroupLabels': ['Vaccination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32701', 'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Cangene Plasma Resources, Mid-Florida', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}], 'overallOfficials': [{'name': 'Ronald Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cangene Plasma Resources, Mid-Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emergent BioSolutions', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}