Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-28 @ 4:35 PM
Study NCT ID:
NCT02961595
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2016-11-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Live Enterovirus Vaccine and Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011055', 'term': 'Poliovirus Vaccine, Oral'}], 'ancestors': [{'id': 'D023321', 'term': 'Poliovirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hanna.viskari@uta.fi', 'title': 'Hanna Viskari', 'organization': 'University of Tampere'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed at the study clinic visits during follow-up of two years (3, 6, 9, 12, 18 and 24 months of age) and thereafter at follow-up visits trough study completion if reported', 'eventGroups': [{'id': 'EG000', 'title': 'Inactivated Polio Vaccine (IPV)', 'description': 'The control group received inactivated poliovirus vaccine (IPV) at the age of 6 and 12 months and 2, 6, and 9-12 years according to the national immunization protocol in Finland at that time.', 'otherNumAtRisk': 251, 'deathsNumAtRisk': 251, 'otherNumAffected': 0, 'seriousNumAtRisk': 251, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Oral Polio Vaccine (OPV)', 'description': 'Intervention group were given doses of oral polio vaccine OPV (Polio Sabin®) at the age of 2, 3, 6 and 12 months. After the age of 12 months they were recommended to continue according to the national immunisation programme with IPV at the age of 2, 6 and 9-12 years.\n\nOral Polio Vaccine (OPV): Serial Oral Polio Vaccine (OPV) was given to intervention group instead of inactivated poliovirus vaccine (IPV).', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 0, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With the Appearance of Type 1 Diabetes Associated Auto-antibodies in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inactivated Polio Vaccine (IPV)', 'description': 'The control group received inactivated poliovirus vaccine (IPV) at the age of 6, 12 months and 2, 6 and 9-12 years according to the national immunization protocol in Finland at that time.'}, {'id': 'OG001', 'title': 'Oral Polio Vaccine (OPV)', 'description': 'Intervention group were given doses of oral polio vaccine OPV (Polio Sabin®) at the age of 2, 3, 6 and 12 months. After the age of 12 months they were recommend to continue according to the national immunisation programme with IPV at the age of 2, 6 and 9-12 years.\n\nOral Polio Vaccine (OPV): Serial Oral Polio Vaccine (OPV) was given to intervention group instead of inactivated poliovirus vaccine (IPV).'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, an average of 11 years', 'description': 'Appearance of multiple type 1 diabetes associated auto-antibodies (2-4 of the measured four auto-antibodies ICA, IAA, GADA, IA-2A)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Enterovirus RNA Positive Stool Samples During the Follow-up of 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'units': 'stool samples', 'counts': [{'value': '744', 'groupId': 'OG000'}, {'value': '744', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inactivated Polio Vaccine (IPV)', 'description': 'The control group received inactivated poliovirus vaccine (IPV) at the age of 6, 12 months and 2, 6 and 9-12 years according to the national immunization protocol in Finland at that time.'}, {'id': 'OG001', 'title': 'Oral Polio Vaccine (OPV)', 'description': 'Intervention group were given doses of oral polio vaccine OPV (Polio Sabin®) at the age of 2, 3, 6 and 12 months. After the age of 12 months they were recommend to continue according to the national immunisation programme with IPV at the age of 2, 6 and 9-12 years.\n\nOral Polio Vaccine (OPV): Serial Oral Polio Vaccine (OPV) was given to intervention group instead of inactivated poliovirus vaccine (IPV).'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to 24 months of age', 'description': 'Percentage of enterovirus RNA positive stool samples during the follow-up of 24 months in IPV and OPV vaccinated children', 'unitOfMeasure': 'stool samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'stool samples', 'denomUnitsSelected': 'stool samples', 'populationDescription': 'Overall 1488 stools samples were collected and analysed from 3 to 24 months in both IPV and OPV groups'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inactivated Polio Vaccine (IPV)', 'description': 'The control group received inactivated poliovirus vaccine (IPV) at the age of 6, 12 months and 2, 6 and 9-12 years according to the national immunization protocol in Finland at that time.'}, {'id': 'FG001', 'title': 'Oral Polio Vaccine (OPV)', 'description': 'Intervention group were given doses of oral polio vaccine OPV (Polio Sabin®) at the age of 2, 3, 6 and 12 months. After the age of 12 months they were recommend to continue according to the national immunisation programme with IPV at the age of 2, 6 and 9-12 years.\n\nOral Polio Vaccine (OPV): Serial Oral Polio Vaccine (OPV) was given to intervention group instead of inactivated poliovirus vaccine (IPV).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Inactivated Polio Vaccine (IPV)', 'description': 'The control group received inactivated poliovirus vaccine (IPV) at the age of 6, 12 months and 2, 6 and 9-12 years according to the national immunization protocol in Finland at that time.'}, {'id': 'BG001', 'title': 'Oral Polio Vaccine (OPV)', 'description': 'Intervention group were given doses of oral polio vaccine OPV (Polio Sabin®) at the age of 2, 3, 6 and 12 months. After the age of 12 months they were recommend to continue according to the national immunisation programme with IPV at the age of 2, 6 and 9-12 years.\n\nOral Polio Vaccine (OPV): Serial Oral Polio Vaccine (OPV) was given to intervention group instead of inactivated poliovirus vaccine (IPV).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Finland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 315}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-18', 'studyFirstSubmitDate': '2016-11-02', 'resultsFirstSubmitDate': '2018-06-01', 'studyFirstSubmitQcDate': '2016-11-10', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-01', 'studyFirstPostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With the Appearance of Type 1 Diabetes Associated Auto-antibodies in Serum', 'timeFrame': 'Through study completion, an average of 11 years', 'description': 'Appearance of multiple type 1 diabetes associated auto-antibodies (2-4 of the measured four auto-antibodies ICA, IAA, GADA, IA-2A)'}], 'secondaryOutcomes': [{'measure': 'Number of Enterovirus RNA Positive Stool Samples During the Follow-up of 24 Months', 'timeFrame': 'Up to 24 months of age', 'description': 'Percentage of enterovirus RNA positive stool samples during the follow-up of 24 months in IPV and OPV vaccinated children'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Oral polio vaccine', 'Inactivated polio vaccine', 'Enterovirus', 'Type 1 diabetes', 'Autoantibody'], 'conditions': ['Enterovirus Infection', 'Type 1 Diabetes', 'Prediabetic State']}, 'referencesModule': {'references': [{'pmid': '28866779', 'type': 'DERIVED', 'citation': 'Viskari H, Oikarinen S, Hoppu S, Vuorinen T, Huhtala H, Toppari J, Veijola R, Ilonen J, Knip M, Hyoty H. Live attenuated enterovirus vaccine (OPV) is not associated with islet autoimmunity in children with genetic susceptibility to type 1 diabetes: prospective cohort study. Diabetologia. 2018 Jan;61(1):203-209. doi: 10.1007/s00125-017-4410-4. Epub 2017 Sep 2.'}], 'seeAlsoLinks': [{'url': 'http://dipp.utu.fi', 'label': 'The Diabetes Prediction and Prevention Project web pages'}]}, 'descriptionModule': {'briefSummary': 'Enterovirus infections may either increase or decrease the risk of type 1 diabetes depending on the age of infection and the type of enterovirus in question. This study evaluated whether early serial exposures to three replication-competent enterovirus strains (live poliovirus vaccine, OPV) can influence the immunity to other enteroviruses and the possible initiation of autoantibodies e.g. islet autoimmunity in young genetically predisposed children.', 'detailedDescription': 'Enteroviruses have been associated with type 1 diabetes in several studies. Enterovirus infections may either increase or decrease the risk of type 1 diabetes depending on the age of infection and the type of enterovirus in question. There is remarkable homology between the structure of poliovirus and other enteroviruses. It has been shown in previous studies that the T-lymphocytes recognize these structures and cross-react with different enterovirus serotypes. Our hypothesis is that polio vaccination induces a cross-reacting T-cell response which strengthens enterovirus immunity and thus accelerate the elimination of the enterovirus infections. We evaluated whether early serial live enterovirus vaccine (oral polio vaccine, OPV) can influence the enterovirus immunity and initiation of islet autoimmunity in young genetically predisposed children.\n\nThis study was carried out in the birth cohort of the ongoing Diabetes Prediction and Prevention (DIPP) study in Finland. All the children carried HLA-DQ genes conferring moderately increased risk for type 1 diabetes (HLA DQB1\\*0302/x, x≠ DQB1\\*0201, \\*0301, \\*0602). Sixty-four children (34 males) were given doses of OPV (Polio Sabin®, SB Biologicals, Rixensart, Belgium) at the age of 2, 3, 6 and 12 months during the years 1999-2000 (two drops per os in each dose). This vaccine includes attenuated replication competent strains of the three poliovirus types (polioviruses 1, 2, 3) leading to infection in vaccinated children. The control group comprising 251 children received inactivated poliovirus vaccine (IPV) at the age of 6 and 12 months according to the national immunization protocol in Finland at that time. After the age of 12 months both groups were recommended to continue the national immunization program with IPV vaccine.\n\nAll children were followed regularly from birth with blood samples taken at 3-12 months interval for detection of type 1 diabetes-associated autoantibodies in serum including insulin autoantibodies (IAA), islet cell cytoplasmic antibody (ICA), insulinoma-associated protein 2 antibodies (IA-2A) and GAD antibodies (GADA) (5-7). Stool samples were collected monthly at the age of 2-24 months and systematically screened for the presence of enterovirus and using RT-PCR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Months', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The infants parents give signed consent to participate and their HLA genotype is eligible\n\nExclusion Criteria:\n\n* The newborn has a recognizable severe illness such as those due to chromosomal abnormality, congenital malformation'}, 'identificationModule': {'nctId': 'NCT02961595', 'briefTitle': 'Live Enterovirus Vaccine and Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University'}, 'officialTitle': 'Live Enterovirus Vaccine and Type 1 Diabetes', 'orgStudyIdInfo': {'id': '98203M Knip M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Inactivated Polio Vaccine (IPV)', 'description': 'The control group received inactivated poliovirus vaccine (IPV) at the age of 6 and 12 months according to the national immunization protocol in Finland at that time.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Polio Vaccine (OPV)', 'description': 'Intervention group were given doses of oral polio vaccine OPV (Polio Sabin®) at the age of 2, 3, 6 and 12 months.', 'interventionNames': ['Biological: Oral Polio Vaccine (OPV)']}], 'interventions': [{'name': 'Oral Polio Vaccine (OPV)', 'type': 'BIOLOGICAL', 'description': 'Serial Oral Polio Vaccine (OPV) was given to intervention group instead of inactivated poliovirus vaccine (IPV).', 'armGroupLabels': ['Oral Polio Vaccine (OPV)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mikael Knip, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital, University of Helsinki, and Helsinki University Central Hospital and Tampere University Hospital, Finland"}, {'name': 'Heikki Hyöty, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tampere, Finland'}, {'name': 'Hanna Viskari, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tampere, Finland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Hanna Viskari', 'investigatorAffiliation': 'Tampere University'}}}}