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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00057499
Other study ID # DAIT ITN012AI
Secondary ID DAIT BD012
Status Completed
Phase Phase 1
First received April 3, 2003
Last updated February 6, 2017
Start date March 2003
Est. completion date March 2007

Study information

Verified date February 2017
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Insulin dependent diabetes mellitus (also called type 1 diabetes mellitus or T1DM) is caused by the destruction of insulin-producing cells in the pancreas. People with T1DM do not produce enough insulin, which is necessary for proper regulation of blood sugar levels.

T1DM is an autoimmune disease. An autoimmune disease is a disease in which the body's immune system attacks the body itself. In addition to regulating blood sugar, insulin may have the ability to protect cells in the pancreas from attack by the immune system. This study will evaluate whether an insulin-based vaccine can protect cells from autoimmune destruction.

Study hypothesis: IFA-enhanced human insulin B-chain vaccination will lead to the arrest or slowing of the ongoing autoimmunity, and this will result in an appreciable difference in functioning B cell mass compared to the placebo treated group by the end of the study.


Description:

The vaccine in this study, IBC-VSO1, is a synthetic, metabolically inactive form of insulin designed to prevent pancreatic beta-cell destruction. It does not cause fluctuations in blood sugar. This study will evaluate whether the vaccine protects against autoimmune attack at the onset of T1DM, before pancreas function has deteriorated. This experimental treatment must occur early because 60% to 85% of beta-cells are already destroyed by the time of T1DM diagnosis. If beta-cell destruction can be halted, a prolonged remission period after diagnosis may occur, with a subsequent delay in diabetes-related complications.

Participants must have been diagnosed with T1DM for no more than 3 months at the time of enrollment in this study. Participants will be randomly assigned to either a vaccine group or a control group. Participants in the vaccine group will receive one injection of IBC-VS01; participants in the control group will receive a placebo. Participants will then be monitored for 2 years. Participants will have ten follow-up visits, which will include blood tests for immunological and genetic analysis. Throughout the study, metabolic tests will also be performed to measure the remaining capacity of self insulin production of the body.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
IBC-VS01
IBC-VS01
IBC-VS01 placebo
IBC-VS01 placebo

Locations

Country Name City State
United States Children's Hospital Boston Massachusetts
United States Joslin Diabetes Center Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network (ITN)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Orban T, Farkas K, Jalahej H, Kis J, Treszl A, Falk B, Reijonen H, Wolfsdorf J, Ricker A, Matthews JB, Tchao N, Sayre P, Bianchine P. Autoantigen-specific regulatory T cells induced in patients with type 1 diabetes mellitus by insulin B-chain immunotherap — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical endpoints including adverse events, local reactions, routine physical exams, insulin dose, and laboratory tests Throughout study
Secondary C-peptide levels in response to mixed meal tolerance test Throughout study
Secondary HbA1c, GAD65Ab, IAA, IA2Ab, GAD65Ab isotypes Throughout study
Secondary CD4- and CD8- Va24JaQ+ Throughout study
Secondary T cells' secretion of IL-4 and Interferon (IFN)-gamma Throughout study
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