Autoantigen Vaccination In Human Type 1 Newly Diagnosed Diabetes Mellitus
Principal InvestigatorTihamer Orban, MD
Joslin Diabetes Center
This is a clinical study to investigate the safety and the immunologic response to an injection of human insulin B-chain in incomplete Freund's adjuvant (IFA) in humans.
With the ultimate goal of developing an intervention to prevent the immune destruction leading to beta-cell (insulin producing cell) loss, we will evaluate the clinical and immunological effects of this novel approach in participants with Type 1 diabetes (T1DM). The effects of this intervention on general immune responses, diabetes specific immune responses, and the deterioration of beta-cell function that occurs in T1DM will be studied in order to determine whether the vaccine alters immune responses associated with T1DM, and whether the vaccine has prolonged clinical efficacy. In this trial, we will also test, whether this novel approach can minimize or prevent long-term insulin dependence when administered to newly diagnosed diabetics.
Participating Clinical SitesJoslin Diabetes Center, Boston, Massachusetts
Children's Hospital, Boston Massachusetts
We are currently seeking otherwise healthy men and women between ages 18-35 who have been diagnosed with type 1 diabetes mellitus less than three months. Candidates must not have a history of treatment with oral hypoglycemic agents or ongoing use of medications known to influence glucose tolerance nor; complications related to routine vaccinations nor; pregnancy or planned pregnancy within the time frame of the study nor; prior participation in trial for prevention of type 1 diabetes mellitus unless the individual is known to be in the placebo arm of a completed prior prevention trial.
Patient Enrollment Information
Eligible participants will receive at no charge:
- Physical examination
- Laboratory tests
- Study Vaccine
- Follow-up tests for 2 years
Monetary Compensation is available
To inquire about your eligibility and enrollment, please contact:Heyam Jalahej M.D.
Clinical Trial Coordinator
Joslin Diabetes Center
One Joslin Place
Boston, MA 02215
June 2, 2003
Updated September 29, 2004
Last Updated: Wednesday September 29, 2004 10:42:34
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