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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
  • NCT 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.

An additional adaptive trial for COVID-19 is also being conducted on these randomized double blinded type 1 diabetic subjects receiving BCG or placebo injections.

An expanded study arm has been approved for repeat dosing of BCG in adult Type I diabetes.

  • Overall Status
    Active, not recruiting
  • Start Date
    June, 2015
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Diabetes Mellitus
  • Type One
  • Diabetes Mellitus
  • Type I
  • Autoimmune Diabetes
  • Covid19

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: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Denise L Faustman, MD, PhD

Role: Principal Investigator

Affiliation: Massachusetts General Hospital

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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