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Live Enterovirus Vaccine and Type 1 Diabetes

NCT02961595 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2024-08-13

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Oral Polio Vaccine (OPV)

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

Sponsors & Collaborators

  • Tampere University

    lead OTHER

Principal Investigators

  • Mikael Knip, Professor · Children's Hospital, University of Helsinki, and Helsinki University Central Hospital and Tampere University Hospital, Finland

  • Heikki Hyöty, Professor · University of Tampere, Finland

  • Hanna Viskari, MD,PhD · University of Tampere, Finland

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
2 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-10-31
Primary Completion
2016-11-30
Completion
2016-11-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02961595 on ClinicalTrials.gov