Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT01173302
Status:
UNKNOWN
Last Update Posted:
2010-08-02
First Post:
2010-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Persistence of Rabies Antibody 1-5 Years After the Post-exposure Prophylaxis With Vero Cell Antirabies Vaccine and Antibody Response to a Single Booster Dose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-04-26', 'releaseDate': '2011-03-31'}, {'resetDate': '2011-08-11', 'releaseDate': '2011-07-19'}, {'resetDate': '2011-11-02', 'releaseDate': '2011-10-02'}], 'estimatedResultsFirstSubmitDate': '2011-03-31'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011818', 'term': 'Rabies'}], 'ancestors': [{'id': 'D018353', 'term': 'Rhabdoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011819', 'term': 'Rabies Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-07-30', 'studyFirstSubmitDate': '2010-07-19', 'studyFirstSubmitQcDate': '2010-07-30', 'lastUpdatePostDateStruct': {'date': '2010-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rabies antibody titer', 'timeFrame': '6 months', 'description': 'We test the antirabies antibody titer before and after the single booster dose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rabies', 'Anti-rabies antibody', 'Persistence'], 'conditions': ['Rabies']}, 'referencesModule': {'references': [{'pmid': '21752947', 'type': 'DERIVED', 'citation': 'Zhang X, Zhu Z, Wang C. Persistence of rabies antibody 5 years after postexposure prophylaxis with vero cell antirabies vaccine and antibody response to a single booster dose. Clin Vaccine Immunol. 2011 Sep;18(9):1477-9. doi: 10.1128/CVI.05090-11. Epub 2011 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'This study is to investigate the persistence of rabies Chinese manufactured antibody 1-5 years after the post-exposure prophylaxis with vero cell antirabies vaccine and antibody response to a single booster dose. A total of 160 subjects would be enrolled. These subjects were all administered ChengDa antirabies vaccine from 2005 to 2009. After informed consent is obtained, these subjects would be tested for their antirabies antibody titer and given a single booster dose. Seven and 14 days later, the investigators would re-evaluate the antibody titer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 to 60 years old\n* Healthy\n* Given ChengDa rabies vaccine\n* Good compliance\n* Obtained informed consent\n\nExclusion Criteria:\n\n* Other than inclusion criteria'}, 'identificationModule': {'nctId': 'NCT01173302', 'briefTitle': 'Persistence of Rabies Antibody 1-5 Years After the Post-exposure Prophylaxis With Vero Cell Antirabies Vaccine and Antibody Response to a Single Booster Dose', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Persistence of Rabies Antibody 1-5 Years After the Post-exposure Prophylaxis With Vero Cell Antirabies Vaccine and Antibody Response to a Single Booster Dose', 'orgStudyIdInfo': {'id': 'PKUPH-ER-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Post vaccination', 'description': 'All the subjects had been vaccinated with antirabies vaccine.', 'interventionNames': ['Biological: Rabies vaccine, manufactured by ChengDa']}], 'interventions': [{'name': 'Rabies vaccine, manufactured by ChengDa', 'type': 'BIOLOGICAL', 'otherNames': ['ChengDa Speeda'], 'description': '1 dose before the antibody is tested', 'armGroupLabels': ['Post vaccination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Wang Chuanlin', 'oldOrganization': "Peking University People's Hospital"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-03-31', 'type': 'RELEASE'}, {'date': '2011-04-26', 'type': 'RESET'}, {'date': '2011-07-19', 'type': 'RELEASE'}, {'date': '2011-08-11', 'type': 'RESET'}, {'date': '2011-10-02', 'type': 'RELEASE'}, {'date': '2011-11-02', 'type': 'RESET'}], 'unpostedResponsibleParty': "Wang Chuanlin, Chief of the Emergency Department, Peking University People's Hospital"}}}}