Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 7:14 PM
Study NCT ID:
NCT00130260
Status:
TERMINATED
Last Update Posted:
2008-01-04
First Post:
2005-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Third and Fourth Dose of StaphVAX® in Adults With End-Stage Renal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C423263', 'term': 'StaphVax'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'whyStopped': 'unsatisfactory efficacy data from preceding trial', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-26', 'studyFirstSubmitDate': '2005-08-12', 'studyFirstSubmitQcDate': '2005-08-12', 'lastUpdatePostDateStruct': {'date': '2008-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serotype-specific antibody concentrations', 'timeFrame': '6 weeks after each dose'}], 'secondaryOutcomes': [{'measure': 'serotype-specific antibody concentrations', 'timeFrame': 'at several other time points up to 12 months after dose'}, {'measure': 'elicited vaccine reactogenicity', 'timeFrame': 'daily for 7 days after each dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Staphylococcus aureus', 'Vaccine', 'Randomized Controlled Trial'], 'conditions': ['Staphylococcal Infections', 'Chronic Kidney Failure']}, 'descriptionModule': {'briefSummary': 'This study is a continued evaluation of the immune response to StaphVAX , a Staphylococcus aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease patients, by giving a 3rd and 4th dose to a subset of the participants in the previous efficacy trial. Participants continue to receive the vaccine or placebo in a blinded manner, and are also randomly assigned to 1 of 2 different intervals between the doses. The immunogenicity is measured by the antibodies in the blood, and typical vaccine safety information is also collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation in prior study Nabi-1371\n* Written informed consent\n* Negative serum pregnancy test, where appropriate\n* Expect to comply with protocol procedures and schedule\n\nExclusion Criteria:\n\n* Known HIV\n* Immunomodulatory drugs\n* Malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer)\n* Active infection in the 2 weeks prior to study injection\n* Serious S. aureus infection within the last 2 months prior to injection\n* Hypersensitivity to components of StaphVAX'}, 'identificationModule': {'nctId': 'NCT00130260', 'acronym': 'SHIELD-2', 'briefTitle': 'Evaluation of a Third and Fourth Dose of StaphVAX® in Adults With End-Stage Renal Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nabi Biopharmaceuticals'}, 'officialTitle': 'Phase 3b Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Evaluating Immunogenicity and Safety of a 3rd and 4th Dose of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults With End-Stage Renal Disease', 'orgStudyIdInfo': {'id': 'Nabi-1372'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vaccine, schedule 1', 'description': '3rd and 4th dose of vaccine, on original schedule', 'interventionNames': ['Biological: Staph aureus types 5 and 8 conjugate vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'vaccine, schedule 2', 'description': '3rd and 4th dose of vaccine on modified schedule', 'interventionNames': ['Biological: Staph aureus types 5 and 8 conjugate vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo, schedule 1', 'description': '3rd and 4th dose of placebo, on original schedule', 'interventionNames': ['Biological: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo, schedule 2', 'description': '3rd and 4th dose of placebo on modified schedule', 'interventionNames': ['Biological: placebo']}], 'interventions': [{'name': 'Staph aureus types 5 and 8 conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['StaphVAX®'], 'description': 'each IM dose contains 200 mc total conjugate', 'armGroupLabels': ['vaccine, schedule 1', 'vaccine, schedule 2']}, {'name': 'placebo', 'type': 'BIOLOGICAL', 'description': 'placebo to match StaphVAX', 'armGroupLabels': ['placebo, schedule 1', 'placebo, schedule 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'multiple sites: contact Central Study coordination', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Matt Hohenboken, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nabi Biopharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nabi Biopharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Matt Hohenboken, MD, PhD, Executive Director Clinical & Medical Affairs', 'oldOrganization': 'Nabi Biopharmaceuticals'}}}}