Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT00697567
Status:
COMPLETED
Last Update Posted:
2008-06-16
First Post:
2008-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1992-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '1997-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-13', 'studyFirstSubmitDate': '2008-06-12', 'studyFirstSubmitQcDate': '2008-06-13', 'lastUpdatePostDateStruct': {'date': '2008-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1997-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the immunogenicity of herpes simplex vaccine, with or without MPL, in healthy adult HSV seropositive and HSV seronegative volunteers', 'timeFrame': 'Days 0, 30, 60, 180 and 365 after vaccination'}, {'measure': 'To evaluate the reactogenicity and safety of the MPL-containing and non-MPL-containing vaccine in healthy adult HSV seronegative and seropositive volunteers', 'timeFrame': 'Reactogenicity from day 0 to day 6 after vaccination. Safety from day 0 to day 365 after vaccination'}]}, 'conditionsModule': {'keywords': ['Herpes simplex', 'Herpes simplex vaccine'], 'conditions': ['Prophylaxis Herpes Simplex']}, 'descriptionModule': {'briefSummary': 'The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.', '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* Written informed consent\n* Female volunteers must be using contraceptive and should avoid becoming pregnant for the duration of this study.\n* Good clinical condition as evidenced by history taking and physical examination\n\nExclusion Criteria:\n\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* Seropositive for antibodies against the human immunodeficiency virus (HIV).\n* Pregnancy, lactation.\n* Treatment with corticosteroids or immunomodulating drugs.\n* Simultaneous participation in another clinical trial.\n* Any previous history of allergy.\n* Any concomitant vaccination or administration of immunoglobulin during the study period.\n* Any abnormal laboratory value among the tests performed at screening'}, 'identificationModule': {'nctId': 'NCT00697567', 'briefTitle': 'Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Study in Healthy HSV Positive and HSV Negative Adults to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' Herpes Simplex (gD) Candidate Vaccine With or Without Adjuvant", 'orgStudyIdInfo': {'id': '208141/002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'HSV seropositive subjects', 'interventionNames': ['Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'HSV seronegative subjects', 'interventionNames': ['Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'HSV seropositive subjects', 'interventionNames': ['Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant']}, {'type': 'EXPERIMENTAL', 'label': 'Group D', 'description': 'HSV seronegative subjects', 'interventionNames': ['Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant']}], 'interventions': [{'name': 'Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, 3 doses', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, 3 doses', 'armGroupLabels': ['Group C', 'Group D']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Isabelle Harpigny', 'oldOrganization': 'GSK'}}}}