NCT02961595

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 1999

Longer than P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
17.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
7.7 years until next milestone

Results Posted

Study results publicly available

July 18, 2024

Completed
Last Updated

August 13, 2024

Status Verified

July 1, 2024

Enrollment Period

17.1 years

First QC Date

November 2, 2016

Results QC Date

June 1, 2018

Last Update Submit

July 18, 2024

Conditions

Enterovirus InfectionType 1 DiabetesPrediabetic State

Keywords

Oral polio vaccineInactivated polio vaccineEnterovirusType 1 diabetesAutoantibody

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With the Appearance of Type 1 Diabetes Associated Auto-antibodies in Serum

    Appearance of multiple type 1 diabetes associated auto-antibodies (2-4 of the measured four auto-antibodies ICA, IAA, GADA, IA-2A)

    Through study completion, an average of 11 years

Secondary Outcomes (1)

  • Number of Enterovirus RNA Positive Stool Samples During the Follow-up of 24 Months

    Up to 24 months of age

Study Arms (2)

Inactivated Polio Vaccine (IPV)

NO INTERVENTION

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.

Oral Polio Vaccine (OPV)

ACTIVE COMPARATOR

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)

Interventions

Oral Polio Vaccine (OPV)BIOLOGICAL

Serial Oral Polio Vaccine (OPV) was given to intervention group instead of inactivated poliovirus vaccine (IPV).

Oral Polio Vaccine (OPV)

Eligibility Criteria

Age1 Day - 2 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • The newborn has a recognizable severe illness such as those due to chromosomal abnormality, congenital malformation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28866779DERIVED

Related Links

MeSH Terms

Conditions

Enterovirus InfectionsDiabetes Mellitus, Type 1Prediabetic State

Interventions

Poliovirus Vaccine, Oral

Condition Hierarchy (Ancestors)

Picornaviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Poliovirus VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Hanna Viskari
Organization
University of Tampere
hanna.viskari@uta.fi

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 11, 2016

Study Start

October 1, 1999

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

August 13, 2024

Results First Posted

July 18, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share