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Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00057499
First Posted: April 4, 2003
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose

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 Intervention Phase
Insulin-dependent Diabetes Mellitus Diabetes Mellitus Biological: IBC-VS01 Biological: IBC-VS01 placebo Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Clinical endpoints including adverse events, local reactions, routine physical exams, insulin dose, and laboratory tests [ Time Frame: Throughout study ]

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

Enrollment: 12
Study Start Date: March 2003
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057499


Locations
United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
Investigators
Principal Investigator: Tihamer Orban, MD Joslin Diabetes Center
  More Information

Additional Information:
Publications:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SDY568
ImmPort study identifier is SDY568.
Study summary, -schematic, -design, medications,-demographics, - lab tests, -study files  This link exits the ClinicalTrials.gov site
Identifier: SDY568
ImmPort study identifier is SDY568.
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: ITN012AI
TrialShare is the Immune Tolerance Network (ITN) portal that makes data from the consortium's clinical trials publicly available without charge. Creating an account for ITN TrialShare is free and allows for searching studies of interest.
Study protocol synopsis, -navigator, -schedule of events,-data &reports, -specimens et al.  This link exits the ClinicalTrials.gov site
Identifier: ITN012AI
TrialShare is the Immune Tolerance Network (ITN) portal that makes data from the consortium's clinical trials publicly available without charge. Creating an account for ITN TrialShare is free and allows for searching studies of interest.

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00057499     History of Changes
Other Study ID Numbers: DAIT ITN012AI
DAIT BD012
First Submitted: April 3, 2003
First Posted: April 4, 2003
Last Update Posted: February 8, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data access is provided to the public in : 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools available to researchers; and 2.) TrialShare, the Immune Tolerance Network (ITN) portal.

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Juvenile diabetes
Diabetes
Insulin
Vaccine
Type 1 Diabetes
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs