Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/23/2017 |
| Start Date: | June 2015 |
| End Date: | July 2023 |
| Contact: | Denise L Faustman, MD, PhD |
| Email: | diabetestrial@partners.org |
| Phone: | 617-726-4084 |
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.
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.
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)
We found this trial at
1
site
Charlestown, Massachusetts 02129
Principal Investigator: Denise L. Faustman, MD, PhD
Phone: 617-726-4084
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