Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT00373412
Status:
COMPLETED
Last Update Posted:
2008-05-08
First Post:
2006-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial of pDNA CMV Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae 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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'lastUpdateSubmitDate': '2008-05-05', 'studyFirstSubmitDate': '2006-09-06', 'studyFirstSubmitQcDate': '2006-09-07', 'lastUpdatePostDateStruct': {'date': '2008-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CMV-specific immune response post-Towne challenge: gB antibody, T-cell IFN-g ELISPOT, T-cell proliferation assays for IE1, pp65, and/or gB, cytokine and phenotypic flow cytometry responses to pp65, IE1, gB.'}], 'secondaryOutcomes': [{'measure': 'Safety of Towne challenge in subjects who have previously been immunized with a trivalent pDNA CMV vaccine (VCL-CT02).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cytomegalovirus', 'vaccine', 'T cell', 'antibodies'], 'conditions': ['Cytomegalovirus Infection']}, 'descriptionModule': {'briefSummary': 'Objectives of this trial are to:\n\nEvaluate the kinetics and magnitude of the CMV-specific immune response post-Towne challenge (3000 pfu) in healthy CMV-seronegative volunteers who receive VCL CT02 administered (1 mg weekly x 3) 3 months previously compared to randomized controls who do not receive VCL CT02 as measured by:\n\n1. antibody titers for gB;\n2. T-cell IFN-g ELISPOT;\n3. T-cell proliferation assays for IE1, pp65, and/or gB; and\n4. cytokine and phenotypic flow cytometry responses to pp65, IE1, and/or gB.\n\nEvaluate the safety safety of Towne challenge in healthy CMV-seronegative adult subjects who have previously been immunized with a trivalent pDNA CMV vaccine (VCL-CT02) administered intramuscularly.\n\nOur hypothesis is that the immune response to Towne vaccine 3000 pfu challenge after VLC-CT02 priming will be greater than that after Towne vaccination alone.', 'detailedDescription': 'This is a Phase 1, single-center, randomized, open-label trial of the live, attenuated Towne CMV vaccine administered as a "challenge" to healthy, CMV-seronegative, adult subjects who previously receive the CMV immunotherapeutic trivalent pDNA-based vaccine, VCL-CT02, given by intramuscular route at Days 1, 7 and 14 or who receive no VCL-CT02.\n\nUp to 12 healthy, CMV-seronegative subjects will be enrolled. If a subject consents and meets all eligibility criteria, the subject will be randomized to the VCL CT02 (N=6)or control (N=6) groups. VCL CT02-assigned subjects will receive VCL CT02 (1 mg weekly x 3) and then on Day 77 will received Towne vacine (3000 pfu subcutaneously). Control-assigned subjects will receive Towne alone. Safety will be monitored and both antibody to CMV gB and T-cell responses to CMV antigens will be measured at specified intervals for 252 days post Towne challenge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 45 years of age\n* Normal lab values at study entry\n* Good general health\n* Negative CMV IgG antibody test\n\nExclusion Criteria:\n\n* CMV seropositive\n* Recent vaccination(s)\n* Immunodeficiency\n* Vaccination with investigational CMV vaccine(s)\n* Pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT00373412', 'briefTitle': 'Trial of pDNA CMV Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Randomized, Phase 1 Trial to Evaluate Safety and CMV-Specific Immune Response to a pDNA CMV Trivalent Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge in Healthy, CMV- Seronegative Adults', 'orgStudyIdInfo': {'id': 'Jacobson VCL CT-02 TC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'VCL CT02 pDNA vaccine', 'type': 'BIOLOGICAL'}, {'name': 'Towne CMV vaccine', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Positive Health Program, 995 Potrero, 4th Floor', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Mark A Jacobson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vical', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Mark Jacobson, Professor of Medicine', 'oldOrganization': 'UCSF'}}}}