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Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02081326
Recruitment Status : Recruiting
First Posted : March 7, 2014
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):

March 4, 2014
March 7, 2014
March 22, 2017
June 2015
July 2020   (Final data collection date for primary outcome measure)
Improvement in HbA1c [ Time Frame: 1, 2, 3, 4, and 5 years after initial BCG/placebo injection ]
An improvement in the hemoglobin A1c (HbA1c) measurement compared to self
  • Improvement in HbA1c [ Time Frame: 1, 2, 3, 4, and 5 years after initial BCG/placebo injection ]
    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 ]
    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
Complete list of historical versions of study NCT02081326 on ClinicalTrials.gov Archive Site
Change in Immune Response [ Time Frame: 2 and 4 weeks and 1, 2, 3, 4, and 5 years after initial BCG/placebo injection ]
Beneficial immune changes of autoimmune reversal that may also lead to a change in insulin
Change in Immune Response [ Time Frame: Weekly for 4 weeks after BCG/placebo injections ]
Targeted death of bad white blood cells (auto reactive T cells) after each BCG vaccination and change in autoantibodies levels compared to self
  • Stabilization in Urinary C-peptide [ Time Frame: 1, 2, 3, 4, and 5 years after initial BCG/placebo injection ]
    Stabilization or improvement in urinary c-peptide of BCG treated group as compared to placebo group or self
  • Stabilization of Stimulated C-peptide [ Time Frame: 1, 2, 3, 4, and 5 years after initial BCG/placebo injection ]
    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
Stabilization in Urinary C-peptide [ Time Frame: 1, 2, 3, 4, and 5 years after initial BCG/placebo injection ]
Stabilization or improvement in urinary c-peptide of BCG treated group as compared to placebo group or self
 
Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes
Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type One
  • Diabetes Mellitus, Type I
  • Autoimmune Diabetes
  • 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
  • Biological: Saline injection
    2 injections spaced 4 weeks apart during the first year, then 1 injection per year for the next 4 years
  • 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
    Intervention: Biological: Bacillus Calmette-Guérin
  • Placebo Comparator: Saline injection
    2 injections spaced 4 weeks apart during the first year, then 1 injection per year for the next 4 years
    Intervention: Biological: Saline injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
July 2023
July 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 diabetes treated continuously with insulin from time of diagnosis
  • Age 18-65
  • HIV antibody negative
  • Normal CBC
  • HCG negative (females)
  • Anti-GAD Positive (except for subjects with c-peptide <10pmol/L)
  • Fasting or stimulated c-peptide between 5-200 pmol/L
  • Participation in protocol #2001P001379, "Autoimmunity: In Vitro Pathogenesis and Early Detection"

Exclusion Criteria:

  • History of chronic infectious disease such as HIV or hepatitis
  • History of tuberculosis, TB risk factors, positive interferon-gamma release assay (IGRA, also known as the T-SPOT.TB test), or BCG vaccination
  • Current 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 NSAIDs
  • Current treatment with antibiotics
  • History of keloid formation
  • Average HbA1c over the past 5 years (or since diagnosis if duration is less than 5 years) <6.5 or > 8.5%
  • History or evidence of chronic kidney disease (serum creatinine > 1.5mg/dL)
  • History of proliferative diabetic retinopathy that has not been treated with laser therapy
  • 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)
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact: Denise L Faustman, MD, PhD 617-726-4084 diabetestrial@partners.org
United States
 
 
NCT02081326
2013P002633
Yes
Not Provided
Not Provided
Denise Louise Faustman, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Denise L Faustman, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP