Determination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics

November 4, 2013 updated by: David M. Nathan, MD, Massachusetts General Hospital

Determination of Dosing and Frequency of BCG Administration Necessary to Alter T-Lymphocyte Profiles in Type I Diabetics

Type 1 diabetes is caused by an autoimmune destruction of the insulin producing cells of the pancreas. The investigators have discovered the specific autoimmune cells responsible for destroying the insulin-producing cells in an animal model of type 1 diabetes, and the means of destroying those cells.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators are now aiming to use a similar strategy (vaccination with BCG, the vaccine used world-wide to protect against tuberculosis) in human type 1 diabetes to see if the abnormal immune cells can be depleted. This is the first step in trying to cure established type 1 diabetes.

Study Type

Interventional

Enrollment (Actual)

25

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, 02114
        • Diabetes Research Center at Massachusetts General 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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria (Type 1 diabetic subjects):

  • Type 1 diabetes treated continuously with insulin from time of diagnosis
  • Age 18-55
  • Anti-GAD positive
  • HIV antibody negative
  • Normal CBC
  • Negative intermediate PPD test performed and read by study staff
  • HCG Negative (females)

Exclusion Criteria Type 1 diabetic subjects):

  • History of chronic infectious disease, such as HIV
  • History of tuberculosis, TB risk factors, or history of + PPD, or BCG vaccination
  • Treatment with glucocorticoids (other than intermittent nasal steroids) or disease or condition likely to require steroid therapy
  • Other conditions or treatments associated with increased risk of infections such as patients with previous history of severe burns, or treatment with immunosuppressive medications of any type (e.g. imuran, methotrexate, cyclosporine, etanercept, infliximab) for any reason
  • Current treatment with aspirin > 160 mg/day or chronic, daily NSAIDs
  • Fasting or stimulated (1 mg glucagon stimulation test) c-peptide > 0.2 pmol/mL
  • History of keloid formation
  • HbA1c > 8.0%
  • History or evidence of chronic kidney disease (serum creatinine > 1.5 mg/dL)
  • History of proliferative diabetic retinopathy that has not been treated with laser therapy
  • Pregnant or not using acceptable birth control
  • Living with someone who is immunosuppressed and/or at high risk for infectious diseases (for example HIV+ or taking immunosuppressive medications for any reason).

Inclusion Criteria (Control Non-diabetic Subjects):

  • Age 18-45

Exclusion Criteria (Control Non-diabetic Subjects):

  • History of autoimmune diseases or diabetes
  • History of HIV History of autoimmune disease or type 1 diabetes (use of insulin continuously since diagnosis) in first degree family members

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: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E
BCG vaccination
Biological: BCG
BCG vaccination at 0 and 4 weeks
Placebo Comparator: P
Saline vaccination
Biological: Saline
Saline vaccination at 0 and 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
concentration of autoreactive t-cells
Time Frame: Measured weekly in first 8 weeks, then every other week for weeks 8-12
Measured weekly in first 8 weeks, then every other week for weeks 8-12

Secondary Outcome Measures

Outcome Measure
Time Frame
Concentration of TNF, TNF-receptors, other cytokines, and c-peptide levels
Time Frame: Weekly for first 8 weeks, then every other week for weeks 8-12
Weekly for first 8 weeks, then every other week for weeks 8-12

Collaborators and Investigators

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

Sponsor

Massachusetts General Hospital

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

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

November 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

January 22, 2008

First Submitted That Met QC Criteria

February 4, 2008

First Posted (Estimate)

February 5, 2008

Study Record Updates

Last Update Posted (Estimate)

November 5, 2013

Last Update Submitted That Met QC Criteria

November 4, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007p-001347

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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