Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics
Insulin-dependent Diabetes Mellitus, Diabetes Mellitus
About this trial
This is an interventional treatment trial for Insulin-dependent Diabetes Mellitus focused on measuring Juvenile diabetes, Diabetes, Insulin, Vaccine, Type 1 Diabetes, Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria: Diagnosed with type 1 diabetes mellitus within 3 months prior to study entry Positive for IAA, GAD65, or IA2 antibodies OR positive for GAD65 or IA2 antibodies after 2 weeks of starting insulin treatment Exclusion Criteria: History of treatment with any oral hypoglycemic agent for more than 3 months Ongoing use of medications known to influence glucose tolerance History of immunosuppressive or steroid therapy for more than 3 months within the 2 years prior to study entry Severe active liver, heart, kidney, or immunodeficiency disease that may limit life expectancy or may require immunosuppression during the study Prior complications related to routine vaccinations Prior participation in a trial for prevention of type 1 diabetes mellitus. Individuals who are known to have been in the placebo arm of a completed prevention trial are not excluded. Any condition that may interfere with a participant's ability to comply with the study Pregnancy or planned pregnancy within the time frame of the study
Sites / Locations
- Children's Hospital
- Joslin Diabetes Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
IBC-VS01 vaccine
Control Group
IBC-VS01 vaccine is administered twice.
IBC-VS01 placebo is administered twice