Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT00698893
Status:
COMPLETED
Last Update Posted:
2017-06-02
First Post:
2008-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006561', 'term': 'Herpes Simplex'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1992-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '1992-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-01', 'studyFirstSubmitDate': '2008-06-13', 'studyFirstSubmitQcDate': '2008-06-16', 'lastUpdatePostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1992-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms', 'timeFrame': 'Throughout the study'}, {'measure': 'Measurement of haematology/biochemical parameters on blood samples', 'timeFrame': 'Throughout the study'}, {'measure': 'Vaccine reactogenicity by soliciting of local and general signs/symptoms', 'timeFrame': 'On the day of vaccination and the subsequent 7 days'}, {'measure': 'Vaccine immunogenicity by 6 measurements of anti-HSV antibodies', 'timeFrame': 'From day 0 to day 45 following vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Herpes simplex', 'Herpes simplex candidate (gD) vaccine'], 'conditions': ['Herpes Simplex']}, 'referencesModule': {'references': [{'pmid': '18845199', 'type': 'BACKGROUND', 'citation': 'Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.'}], 'seeAlsoLinks': [{'url': 'https://www.gsk-clinicalstudyregister.com/study/208141/001?search=study&#rs', 'label': 'Results for study 208141/001 can be found on the GSK Clinical Study Register'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety and reactogenicity of candidate gD vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in these subjects will also be evaluated.', 'detailedDescription': 'At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 and 40 years of age\n* Seropositive for antibodies against HSV\n* Female volunteers must have been using contraceptives for at least 2 months before the entry and should avoid becoming pregnant for the duration of this study.\n* Good physical condition as established by physical examination and history taking at the time of entry\n\nExclusion Criteria:\n\n* Any abnormal laboratory value among the tests performed at screening.\n* History of persistent hepatic, renal, cardiac or respiratory diseases\n* Clinical signs of acute illness at the time of entry into the study.\n* Previous history of asthma or hypersensitivity to drugs.\n* Seropositive for antibodies against the human immunodeficiency virus\n* Pregnancy and lactation.\n* Treatment with corticosteroids or immunomodulating drugs.\n* Simultaneous participation in another clinical trial.\n* Administration of any other vaccine or immunoglobulins during the study period'}, 'identificationModule': {'nctId': 'NCT00698893', 'briefTitle': 'Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "An Open Study in Healthy Herpes Simplex Virus (HSV)-Positive Adults to Evaluate the Safety of GSK Biologicals' Candidate gD Vaccine, With or Without 3D MPL", 'orgStudyIdInfo': {'id': '208141/001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'interventionNames': ['Biological: Herpes simplex candidate (gD) vaccine GSK208141']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'interventionNames': ['Biological: Herpes simplex candidate (gD) vaccine GSK208141']}], 'interventions': [{'name': 'Herpes simplex candidate (gD) vaccine GSK208141', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}