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Virus Therapy
BCG Vaccination for Type 1 Diabetes
Phase 2
Waitlist Available
Led By Denise L Faustman, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Type 1 diabetes treated continuously with insulin from time of diagnosis
Age 18-65
Must not have
Current treatment with antibiotics
Average HbA1c over the past 5 years (or since diagnosis if duration is less than 5 years) <6.5 or > 8.5%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months beginning january 2020
Summary
This trial is testing whether or not repeat vaccinations of BCG can help to sustain the beneficial effects seen in the previous Phase I study in long term diabetics.
Who is the study for?
Adults aged 18-65 with Type 1 diabetes, continuously treated with insulin and having specific levels of c-peptide are eligible. They must not have a history of tuberculosis, chronic infections like HIV or hepatitis, severe kidney disease, or be on treatments that suppress the immune system. Women participating should not be pregnant.
What is being tested?
The trial is testing if repeated BCG vaccinations can improve Type 1 diabetes by killing bad white blood cells and possibly restoring insulin secretion from the pancreas. Participants will receive either BCG vaccines or placebo over four years to compare effects.
What are the potential side effects?
BCG vaccination may cause side effects such as soreness at the injection site, low-grade fever, and swelling of lymph nodes. More serious but rare side effects include allergic reactions and bladder irritation in cases where it's used for bladder cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on insulin since my type 1 diabetes diagnosis.
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I am between 18 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking antibiotics.
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My average blood sugar level over the past 5 years has been either below 6.5% or above 8.5%.
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I have had neuropathy, foot ulcers, amputations, or kidney disease.
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I am not on long-term steroids for any condition.
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I have advanced diabetic eye disease that hasn't been treated with laser.
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I am currently taking more than 160 mg of aspirin daily or using NSAIDs every day.
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My kidney function is impaired (creatinine > 1.5mg/dL).
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I have a chronic infectious disease like HIV or hepatitis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 months beginning january 2020
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months beginning january 2020
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in HbA1c values in juvenile onset type 1 diabetics
Secondary study objectives
Autoimmunity in juvenile onset type 1 diabetes (AOO<21 years)
Endogenous insulin levels in the blood in juvenile onset type 1 diabetics (AOO<21 years)
Insulin use in juvenile onset type 1 diabetics (AOO<21 years)
Other study objectives
COVID-19 and BCG Adaptive Study: Impact of COVID-19 (severity, duration of symptoms, absence from work)
COVID-19 and BCG Adaptive Study: Number of Type 1 Diabetics with COVID-19 symptomatic infections
COVID-19 and BCG Adaptive Study: Reported Rates of Infectious Diseases
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bacillus Calmette-GuérinExperimental Treatment1 Intervention
2 BCG vaccinations spaced 4 weeks apart during the first year and then 1 vaccination every year for the next 4 years
Group II: Saline injectionPlacebo Group1 Intervention
2 injections spaced 4 weeks apart during the first year, then 1 injection per year for the next 4 years
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,132 Total Patients Enrolled
Denise L Faustman, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking antibiotics.My average blood sugar level over the past 5 years has been either below 6.5% or above 8.5%.I have a history of tuberculosis or have been vaccinated against it.You have a history of developing keloids.You live with someone who has a weakened immune system or is at high risk for getting sick easily.I have had neuropathy, foot ulcers, amputations, or kidney disease.I have been on insulin since my type 1 diabetes diagnosis.I have conditions or have taken medications that increase my risk of infections.I am not on long-term steroids for any condition.I have tested positive for anti-GAD, except if my c-peptide level is below 10pmol/L.I have advanced diabetic eye disease that hasn't been treated with laser.Your c-peptide levels when fasting or after eating are between 5-200 pmol/L.I am currently taking more than 160 mg of aspirin daily or using NSAIDs every day.My kidney function is impaired (creatinine > 1.5mg/dL).Your blood count is within the normal range.You are not pregnant (for females).I am between 18 and 65 years old.You do not have HIV.I have a chronic infectious disease like HIV or hepatitis.
Research Study Groups:
This trial has the following groups:- Group 1: Saline injection
- Group 2: Bacillus Calmette-Guérin
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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