Type 1 Diabetes Clinical Trial
Official title:
Live Enterovirus Vaccine and Type 1 Diabetes
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.
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.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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