Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-26 @ 12:38 AM
Study NCT ID:
NCT00042094
Status:
COMPLETED
Last Update Posted:
2011-06-30
First Post:
2002-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation of a Cell-Cultured Smallpox Vaccine Compared to Dryvax®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012899', 'term': 'Smallpox'}, {'id': 'D014615', 'term': 'Vaccinia'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2003-03'}, 'lastUpdateSubmitDate': '2011-06-29', 'studyFirstSubmitDate': '2002-07-23', 'studyFirstSubmitQcDate': '2002-07-25', 'lastUpdatePostDateStruct': {'date': '2011-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-07-26', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Smallpox', 'Smallpox Vaccine', 'Vaccinia'], 'conditions': ['Smallpox']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of both Dryvax® and the new cell-cultured vaccine (CCSV) in a comparative fashion. Across 3 cohorts, 150 vaccinia-naive volunteers will be randomly assigned to receive either CCSV (100 volunteers) or Dryvax® (50 volunteers) in a blinded fashion. Subjects will be followed closely for up to 6 months and a subgroup of volunteers will be followed up to 3 years in order to evaluate the duration of immunity following vaccination. Another cohort will enroll 100 vaccinia-experienced volunteers and randomly assign them to receive either CCSV (50 volunteers) or Dryvax® (50 volunteers) and a sub group will be followed up to 3 years. A fifth cohort will enroll 100 vaccinia-naive volunteers and randomly assign them to receive different dilutions of CCSV (1:1, 1:5, 1:25, and 1:50).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* Have never received smallpox vaccine or previously received an experimental smallpox vectored vaccine (for vaccinia-naive cohorts only)\n* Have been previously vaccinated within the last 10 years (vaccinia-experienced cohort only)\n* Must agree to have blood samples banked for future research testing\n* Have not participated in any clinical trial using investigational product within past month\n* No current or past history of exfoliative skin problems\n* Not have regular contact with children under 3 years of age until scab at site of vaccination has fallen off (around 21 days or 3 weeks after vaccination)\n* Do not have a positive test for HIV virus, hepatitis C virus, or hepatitis B surface antigen\n* Are not a health care worker caring for newborns, patients that are immunocompromised or have skin that is adversely altered\n* Will not engage in direct patient care until immunization scab falls off (around 21 days or 3 weeks after vaccination) if health care worker'}, 'identificationModule': {'nctId': 'NCT00042094', 'briefTitle': 'Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation of a Cell-Cultured Smallpox Vaccine Compared to Dryvax®', 'organization': {'class': 'INDUSTRY', 'fullName': 'DynPort Vaccine Company LLC, A GDIT Company'}, 'officialTitle': 'A Phase 1 Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation (Take Rate) of a Cell-Cultured Smallpox Vaccine (CCSV) Compared to a Calf Lymph Vaccine (Dryvax®)', 'orgStudyIdInfo': {'id': 'SMPX-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cell-Cultured Smallpox Vaccine compared to Dryvax®', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536-0084', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Medical Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DynPort Vaccine Company LLC, A GDIT Company', 'class': 'INDUSTRY'}}}}