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Brief Title: Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes

Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes

INTRODUCTION

  • Org Study ID: 2013P002633
  • Secondary ID: N/A
  • NTC ID: NCT02081326
  • Sponsor: Massachusetts General Hospital

BRIEF SUMMARY


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.


  • Overall Status
    Recruiting
  • Start Date
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Improvement in HbA1c

Primary Outcome 1 - Timeframe: 1, 2, 3, 4, and 5 years after initial BCG/placebo injection

CONDITION

  • Diabetes Mellitus
  • Type One
  • Diabetes Mellitus
  • Type I
  • Autoimmune Diabetes

ELIGIBILITY


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)

Gender: All

Minimum Age: 65 Years

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Denise L Faustman, MD, PhD

Role: Principal Investigator

Affiliation: Massachusetts General Hospital

Overall Contact

Name: Denise L Faustman, MD, PhD

Phone: 617-726-4084

Email: diabetestrial@partners.org

LOCATION

Facility Status Contact
Facility: Immunobiology Labs CNY 149
Charlestown, Massachusetts 02129
United States 		Status: Recruiting Contact:
Denise L Faustman, MD, PhD
617-726-4084
diabetestrial@partners.org

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