Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics

February 6, 2017 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Autoantigen Vaccination in Human Type 1 Newly Diagnosed Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical endpoints including adverse events, local reactions, routine physical exams, insulin dose, and laboratory tests
Time Frame: Throughout study
Throughout study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Immune Tolerance Network (ITN)

Investigators

  • Principal Investigator: Tihamer Orban, MD, Joslin Diabetes Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

April 3, 2003

First Submitted That Met QC Criteria

April 3, 2003

First Posted (Estimate)

April 4, 2003

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAIT ITN012AI
  • DAIT BD012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: SDY568
    Information comments: ImmPort study identifier is SDY568.
  2. Study summary, -schematic, -design, medications,-demographics, - lab tests, -study files
    Information identifier: SDY568
    Information comments: ImmPort study identifier is SDY568.
  3. Individual Participant Data Set
    Information identifier: ITN012AI
    Information comments: 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.
  4. Study protocol synopsis, -navigator, -schedule of events,-data &reports, -specimens et al.
    Information identifier: ITN012AI
    Information comments: 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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