Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT00213304
Status:
COMPLETED
Last Update Posted:
2021-08-24
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Safety of Oka Varicella in Children Prior to Solid Organ Transplantation
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-18', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of the safety of VARIVAX™', 'timeFrame': 'Up to 6 months', 'description': 'Eligible subjects given a two-dose OMVV pre transplantation were monitored for Adverse Events. AE were monitored for up to six wk after each dose with the assistance of parent diaries.'}, {'measure': 'Determination of the safety of VARIVAX™', 'timeFrame': 'up to 6 months', 'description': 'All transplant recipients were monitored over the follow-up period for microbiological and clinical evidence of reactivation of other herpes group viruses.'}, {'measure': 'Determination of the proportion immunized who demonstrate seroconversion and maintain humoral immunity seroconversion at 6, 12 and 24 months post-transplantation', 'timeFrame': 'up to 12 months', 'description': 'Control antigen was prepared in parallel from uninfected cells. A gpELISA antibody level of \\>0.6 gpEU/mL defined seroconversion, and a gpELISA antibody level exceeding 5 gpEU/mL defined seroprotection.'}, {'measure': 'Determination of the proportion immunized who demonstrate seroconversion and maintain humoral immunity seroconversion at 6, and 12 months post-transplantation', 'timeFrame': 'Up to 12 months', 'description': 'VZV-specific antibodies were measured at Merck Research Laboratories using a previously validated ELISA method that detected antibodies to VZV glycoproteins purified from VZV-infected human fibroblasts.'}]}, 'conditionsModule': {'keywords': ['organ transplantation', 'immunosuppression', 'vaccine', 'varicella', 'pediatrics'], 'conditions': ['Organ Transplantation', 'Immunosuppression']}, 'descriptionModule': {'briefSummary': 'This study sought to determine the safety of the varicella vaccine pre- and post-transplantation when given to pediatric patients listed for solid organ transplantation. The study assessed the antibody response to a two-dose vaccine regimen and determined the durability of that antibody response at several intervals in the post-transplant period. As a secondary objective, the relationship between antibody titers and different variables were explored'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '9 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children \\> 9 months of age and adolescents \\< 18 years of age.\n* Pediatric transplant candidates who are in any of the following categories:\n\n 1. listed to receive kidney, liver, heart, lung or other or solid organ transplantation in a Canadian transplant centre\n 2. not yet officially listed, but are regarded by their physicians as transplant candidates by virtue of their underlying diseases\n* No clinical history for varicella.\n* Seronegative for antibodies to VZV except infants 9 - 12 months of age who may be seropositive due to maternal antibodies.\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Previous immunization with varicella vaccine.\n* Any established immune deficiency (underlying disease or drug induced) or any neoplastic disease\n* Children on any oral and / or intravenous steroids within 3 months prior to immunization. Children on inhaled corticosteroids in excess of 800 mcg of beclomethasone dipropionate ( or equivalent ) per day.\n* Any exposure to varicella or herpes zoster in the previous 4 weeks involving household, playmate or hospital contacts.\n* Inability to delay the transplantation for up to 6 weeks following the last varicella immunization.\n* Presence of a person at increased risk for varicella infection in direct and unavoidable proximity with the vaccinees ( e.g. an immunocompromised sibling)\n* Past history of varicella or known positive antibody titer for varicella except infants 9 - 12 months of ages who may be seropositive due to maternal antibodies\n* Known hypersensitivity to any of the components of the vaccine, including neomycin and gelatin\n* Patients whose mothers are known to be seronegative and plan to become pregnant in the subsequent three months\n* Administration of VZIG or any other blood products in the previous six weeks (packed red blood cells excepted).\n* Any significant infection and/or fever at the time of vaccination\n* Any patient receiving or planning to receive salicylates in the six weeks after immunization\n* Any patient who has received any live vaccine for 6 weeks or killed vaccine for 2 weeks prior to or after the scheduled VARIVAX™ vaccination.'}, 'identificationModule': {'nctId': 'NCT00213304', 'briefTitle': 'The Safety of Oka Varicella in Children Prior to Solid Organ Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Safety and Immunogenicity of Live Attenuated Oka/Merck Varicella Vaccine in Children Listed to Undergo Solid Organ Transplantation', 'orgStudyIdInfo': {'id': '0019990029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'varicella vaccine (VARIVAX)', 'description': 'varicella vaccine (VARIVAX)', 'interventionNames': ['Biological: varicella vaccine (VARIVAX)']}], 'interventions': [{'name': 'varicella vaccine (VARIVAX)', 'type': 'BIOLOGICAL', 'armGroupLabels': ['varicella vaccine (VARIVAX)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Upton Allen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children, Toronto Canada'}, {'name': 'Upton Allen', 'role': 'STUDY_CHAIR', 'affiliation': 'The Hospital for Sick Children'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Division of Infectious Diseases', 'investigatorFullName': 'Upton Allen', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}