Trial record 5 of 8837 for:    diabetes

Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Denise Louise Faustman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02081326
First received: March 4, 2014
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to see if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on Type 1 diabetes. Published Phase I data on repeat BCG vaccinations in long term diabetics showed specific death of some of the disease causing bad white blood cells and also showed a short and small pancreas effect of restored insulin secretion. In this Phase II study, the investigators will attempt to vaccinate more frequently to see if these desirable effects can be more sustained.

Eligible volunteers will either be vaccinated with BCG in a repeat fashion over a period of four years or receive a placebo treatment. The investigators hypothesize that each BCG vaccination will eliminate more and more of the disease causing white blood cells that could offer relief to the pancreas for increased survival and restoration of insulin secretion from the pancreas.


Condition Intervention Phase
Diabetes Mellitus, Type One
Diabetes Mellitus, Type I
Autoimmune Diabetes
Biological: Bacillus Calmette-Guérin
Biological: Saline injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Improvement in HbA1c [ Time Frame: 1, 2, 3, 4, and 5 years after initial BCG/placebo injection ] [ Designated as safety issue: No ]
    An improvement in the hemoglobin A1c (HbA1c) measurement compared to self

  • Stabilization of Stimulated C-peptide [ Time Frame: 1, 2, 3, 4, and 5 years after initial BCG/placebo injection ] [ Designated as safety issue: No ]
    Improvement or stabilization in stimulated C-peptide (self insulin) as measured by a mixed meal tolerance test (MMTT) when compared to self or placebo treated group


Secondary Outcome Measures:
  • Change in Immune Response [ Time Frame: Weekly for 4 weeks after BCG/placebo injections ] [ Designated as safety issue: No ]
    Targeted death of bad white blood cells (auto reactive T cells) after each BCG vaccination and change in autoantibodies levels compared to self


Other Outcome Measures:
  • Stabilization in Urinary C-peptide [ Time Frame: 1, 2, 3, 4, and 5 years after initial BCG/placebo injection ] [ Designated as safety issue: No ]
    Stabilization or improvement in urinary c-peptide of BCG treated group as compared to placebo group or self


Estimated Enrollment: 120
Study Start Date: May 2014
Estimated Study Completion Date: May 2022
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bacillus Calmette-Guérin
2 BCG vaccinations spaced 4 weeks apart during the first year and then 1 vaccination every year for the next 4 years
Biological: Bacillus Calmette-Guérin
2 BCG vaccinations spaced 4 weeks apart during the first year and then 1 vaccination every year for the next 4 years
Placebo Comparator: Saline injection
2 injections spaced 4 weeks apart during the first year, then 1 injection per year for the next 4 years
Biological: Saline injection
2 injections spaced 4 weeks apart during the first year, then 1 injection per year for the next 4 years

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes treated continuously with insulin from time of diagnosis
  • Age 18-60
  • HIV antibody negative
  • Normal complete blood count (CBC)
  • Human chorionic gonadotropin (HCG) negative (females)
  • Anti-glutamic acid decarboxylase (GAD) Positive
  • Fasting or stimulated (using a mixed meal tolerance test) c-peptide between 5-200pmol/L

Exclusion Criteria:

  • History of chronic infectious disease, such as human immunodeficiency virus (HIV), herpes, hepatitis
  • History of tuberculosis (TB), TB risk factors, positive purified protein derivative (PPD), or BCG vaccination
  • Treatment with glucocorticoids (other than intermittent nasal or eye steroids), or disease or condition likely to require steroid therapy
  • Other conditions or treatments associated with increased risk of infections such as patients with a 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 non-steroidal anti-inflammatory drugs (NSAIDs)
  • Current treatment with antibiotics
  • History of keloid formation
  • HbA1c <6.5 or > 8.5%
  • History or evidence of chronic kidney disease (serum creatinine > 1.5mg/dL)
  • History of proliferative diabetic retinopathy
  • History of neuropathy, foot ulcers, amputations, or kidney disease
  • 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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02081326

Contacts
Contact: Denise L Faustman, MD, PhD 617-726-4084 diabetestrial@partners.org

Locations
United States, Massachusetts
Immunobiology Labs CNY 149 Not yet recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Denise L Faustman, MD, PhD    617-726-4084    diabetestrial@partners.org   
Principal Investigator: Denise L. Faustman, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Denise L Faustman, MD, PhD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Denise Louise Faustman, MD, Denise Louise Faustman, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02081326     History of Changes
Other Study ID Numbers: 2013P002633
Study First Received: March 4, 2014
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Diabetes Mellitus, Type One
Diabetes Mellitus, Type I
Autoimmune Diabetes
Insulin Dependent Diabetes Mellitus 1
IDDM

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

ClinicalTrials.gov processed this record on July 29, 2014