Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-01-29 @ 10:14 AM
Study NCT ID:
NCT02692066
Status:
WITHDRAWN
Last Update Posted:
2018-05-09
First Post:
2016-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response and Clearance of Viral DNA Following Administration of Live Attenuated Varicella Vaccine.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002644', 'term': 'Chickenpox'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019433', 'term': 'Chickenpox Vaccine'}], 'ancestors': [{'id': 'D022283', 'term': 'Herpesvirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Funding not acquired', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-03', 'studyFirstSubmitDate': '2016-02-19', 'studyFirstSubmitQcDate': '2016-02-24', 'lastUpdatePostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clearance of viral DNA', 'timeFrame': '4 weeks'}, {'measure': 'humoral response', 'timeFrame': '4 weeks'}, {'measure': 'cell mediated response', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Varicella', 'Transplants']}, 'descriptionModule': {'briefSummary': 'Varicella zoster virus (VZV) can lead to significant morbidity and mortality in transplant recipients. Current recommendations suggest a 4 week waiting period between vaccination and transplantation and consideration of booster immunizations if antibody response does not reach target levels. This four week waiting period can result in delayed transplant, rejection of an optimal organ, or missed opportunity to vaccinate. However, these recommendations are not evidence based.\n\nThis is a prospective study to look at the immune response to varicella vaccine in children with chronic liver disease.\n\nInvestigators will evaluate:\n\n1. the time at which VZV DNA becomes undetectable in blood and saliva by PCR after vaccination in children with chronic liver disease and\n2. the difference in humoral and cell mediated immune response to varicella immunization between children with chronic liver disease and healthy children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with liver disease and healthy controls who have not received varicella vaccination and who have no history of varicella or zoster', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6 months to 21 years\n* no history of varicella, zoster or prior varicella vaccination\n\nExclusion Criteria:\n\n* acute liver failure\n* liver transplant anticipated within 28 days\n* prior history of receiving blood products or immunoglobulin within 5 months prior to vaccination\n* fever\n* pregnancy\n* immunocompromised status\n* receiving immunosuppressive meds'}, 'identificationModule': {'nctId': 'NCT02692066', 'briefTitle': 'Response and Clearance of Viral DNA Following Administration of Live Attenuated Varicella Vaccine.', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Response and Clearance of Viral DNA Following Administration of Live Attenuated Varicella Vaccine in Children With Liver Disease', 'orgStudyIdInfo': {'id': '15-2042'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Controls', 'description': 'Healthy Children ages 6 months-21 years who have not received varicella vaccine and who do not have prior varicella or zoster will receive Varivax. We will then measure 1) markers of humoral immunity at baseline and 4 weeks post vaccination and 2) markers of cell mediated immunity at baseline, 1 week, and 4 weeks post vaccination', 'interventionNames': ['Biological: varicella vaccine']}, {'label': 'Children with Chronic Liver Disease', 'description': 'Children with chronic liver disease ages 6 months-21 years who have not received varicella vaccine and who do not have prior varicella or zoster will receive Varivax. We will then measure 1) varicella DNA in the blood and saliva at enrollment, 1 week, 2 weeks, 3 weeks, 4 weeks post vaccination 2)markers of humoral immunity at baseline and 4 weeks post vaccination and 3) markers of cell mediated immunity at baseline, 1 week, and 4 weeks post vaccination', 'interventionNames': ['Biological: varicella vaccine']}], 'interventions': [{'name': 'varicella vaccine', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Children with Chronic Liver Disease', 'Healthy Controls']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Amy Feldman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}