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Live Enterovirus Vaccine and Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanna Viskari, University of Tampere
ClinicalTrials.gov Identifier:
NCT02961595
First received: November 2, 2016
Last updated: November 10, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Enterovirus Infection Type 1 Diabetes Prediabetic State Biological: Oral Polio Vaccine (OPV) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Live Enterovirus Vaccine and Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Hanna Viskari, University of Tampere:

Primary Outcome Measures:
  • Appearance of type 1 diabetes associated auto-antibodies in serum [ Time Frame: Through study completion, an average of 11 years ]

Secondary Outcome Measures:
  • Presence of enterovirus RNA in stools [ Time Frame: Up to 24 months of age ]

Enrollment: 315
Study Start Date: October 1999
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Inactivated Polio Vaccine (IPV)
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.
Active Comparator: Oral Polio Vaccine (OPV)
Intervention group were given doses of oral polio vaccine OPV (Polio Sabin®) at the age of 2, 3, 6 and 12 months.
Biological: Oral Polio Vaccine (OPV)
Serial Oral Polio Vaccine (OPV) was given to intervention group instead of inactivated poliovirus vaccine (IPV).

Detailed Description:

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 poliovaccination 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.

This 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.

All 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.

  Eligibility

Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The infants parents give signed consent to participate and their HLA genotype is eligible

Exclusion Criteria:

  • The newborn has a recognizable severe illness such as those due to chromosomal abnormality, congenital malformation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02961595

Sponsors and Collaborators
University of Tampere
Investigators
Principal Investigator: Mikael Knip, Professor Children's Hospital, University of Helsinki, and Helsinki University Central Hospital and Tampere University Hospital, Finland
Principal Investigator: Heikki Hyöty, Professor University of Tampere, Finland
Principal Investigator: Hanna Viskari, MD,PhD University of Tampere, Finland
  More Information

Additional Information:
Responsible Party: Hanna Viskari, Researcher, University of Tampere
ClinicalTrials.gov Identifier: NCT02961595     History of Changes
Other Study ID Numbers: 98203M Knip M
Study First Received: November 2, 2016
Last Updated: November 10, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hanna Viskari, University of Tampere:
Oral polio vaccine
Inactivated polio vaccine
Enterovirus
Type 1 diabetes
Autoantibody

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Prediabetic State
Enterovirus Infections
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017