Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00057499

Collaborator

Immune Tolerance Network (ITN) (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Insulin-dependent Diabetes Mellitus Diabetes Mellitus	Biological: IBC-VS01 Biological: IBC-VS01 placebo	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Autoantigen Vaccination in Human Type 1 Newly Diagnosed Diabetes Mellitus

Study Start Date :

Mar 1, 2003

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IBC-VS01 vaccine IBC-VS01 vaccine is administered twice.	Biological: IBC-VS01 IBC-VS01
Placebo Comparator: Control Group IBC-VS01 placebo is administered twice	Biological: IBC-VS01 placebo IBC-VS01 placebo

Arm

Intervention/Treatment

Experimental: IBC-VS01 vaccine

IBC-VS01 vaccine is administered twice.

Biological: IBC-VS01

IBC-VS01

Placebo Comparator: Control Group

IBC-VS01 placebo is administered twice

Biological: IBC-VS01 placebo

IBC-VS01 placebo

Outcome Measures

Primary Outcome Measures

Clinical endpoints including adverse events, local reactions, routine physical exams, insulin dose, and laboratory tests [Throughout study]

Secondary Outcome Measures

C-peptide levels in response to mixed meal tolerance test [Throughout study]
HbA1c, GAD65Ab, IAA, IA2Ab, GAD65Ab isotypes [Throughout study]
CD4- and CD8- Va24JaQ+ [Throughout study]
T cells' secretion of IL-4 and Interferon (IFN)-gamma [Throughout study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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