dear study participants and potential study participants:
1. You will be ableto discern Bcg from a placebo by the likely response at the injection site. Be sure to ask and carefully record the volume of liquid injected. While the volume may not be useful for inferring the concentration of Bcg , you may note that the standard vaccination dose forbcg is 1 ml. Carefully note the injection technique, eg intradermal and the location of the injection.photograph the injection site and the corresponding opposite location on the body.
It is unethical immoral and worse to compare Bcg an immomodulator with a nothing, saline.
Faustman has already shown that Bcg kills cells with selectivity and beneficial effect. Saline does not!
Please contact me at this log and report to the worldyourexperience.
Trial record 1 of 2 for: Faustman
Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes
Verified June 2015 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Denise Louise Faustman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02081326
First received: March 4, 2014
Last updated: June 8, 2015
Last verified: June 2015
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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:
Genetics Home Reference related topics: type 1 diabetes
MedlinePlus related topics: Diabetes Type 1
Drug Information available for: BCG Vaccine
U.S. FDA Resources
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
Secondary Outcome Measures:
- Change in Immune Response [ Time Frame: 2 and 4 weeks and 1, 2, 3, 4, and 5 years after initial BCG/placebo injection ] [ Designated as safety issue: No ]Beneficial immune changes of autoimmune reversal that may also lead to a change in insulin
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
- 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
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2015 |
| Estimated Study Completion Date: | July 2023 |
| Estimated Primary Completion Date: | July 2020 (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
|
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