Phase 1
Completed N=315
Live Enterovirus Vaccine and Type 1 Diabetes
Enterovirus Infection · Type 1 Diabetes · Prediabetic State
Source: ClinicalTrials.gov NCT02961595 ↗
Enrolled (actual)
315
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Number of Participants With the Appearance of Type 1 Diabetes Associated Auto-antibodies in Serum — 17; 2 Participants
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.
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 | — |
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
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. Informational only — not medical advice.