Phase 1 N=315 Prevention

Live Enterovirus Vaccine and Type 1 Diabetes

Enterovirus Infection · Type 1 Diabetes · Prediabetic State

Bottom Line

View on ClinicalTrials.gov: NCT02961595 ↗

Enrolled (actual)

315

Serious AEs

0.0%

Results posted

Jul 2024

Primary outcome: Primary: Number of Participants With the Appearance of Type 1 Diabetes Associated Auto-antibodies in Serum — 17; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Oral Polio Vaccine (OPV) (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Tampere University
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With the Appearance of Type 1 Diabetes Associated Auto-antibodies in Serum	17; 2	—
SECONDARY Number of Enterovirus RNA Positive Stool Samples During the Follow-up of 24 Months	89; 221	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02961595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.