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Cancer Vaccine
BCG Vaccinations for Type 1 Diabetes
Phase 2
Recruiting
Led By Siham Accacha, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of antibodies to glutamic acid decarboxylase (GAD), islet cell autoantibody (ICA), protein tyrosine phosphatase-like protein antibodies (IA-2), insulin autoantibodies (IAA), zinc transporter 8 antibodies (ZnT8)
Ability and willingness to take at least 3 daily meal-time related bolus insulin injections throughout the trial
Must not have
Blood pressure >90th percentile for their age and sex
Current treatment with aspirin >160 mg/day or chronic, daily NSAIDs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2, 3, 4, and 5 years after initial bcg/placebo injection
Summary
This trial will test if a second BCG vaccination can help kids with Type 1 diabetes by improving their immune and metabolic systems.
Who is the study for?
This trial is for kids aged 12-17 with Type 1 diabetes, who can manage multiple daily insulin injections and use a continuous glucose monitor (CGM). They must have certain diabetes-related antibodies, detectable C-peptide levels, and no history of severe diabetic complications or other serious health conditions. Pregnant teens or those at risk of pregnancy without contraception are excluded.
What is being tested?
The study tests whether repeated BCG vaccinations can improve immune response and blood sugar control in young people with Type 1 diabetes. Participants will either receive the BCG vaccine or a saline injection as a placebo to compare effects.
What are the potential side effects?
BCG vaccination may cause local reactions like pain, redness, or swelling at the injection site. There's also a low risk of fever and mild flu-like symptoms following vaccination.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have antibodies linked to diabetes.
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I am willing and able to take 3 insulin injections daily with meals during the trial.
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I use a daily insulin pump or injections for my diabetes.
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My blood tests are normal, except for a slight increase in creatinine.
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I was diagnosed with type 1 diabetes according to WHO/ADA guidelines.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My blood pressure is higher than what's typical for my age and sex.
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I am currently taking more than 160 mg of aspirin daily or using NSAIDs every day.
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I have been diagnosed with a form of diabetes caused by a single gene.
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I have diabetes because of my cystic fibrosis.
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My average blood sugar level over the past 3 months was either below 7% or above 9%.
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I have diabetes without specific autoantibodies.
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I am pregnant, breastfeeding, planning to become pregnant, or not using birth control.
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I am taking or plan to take oral medication for type 2 diabetes.
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I am not on antibiotics that affect BCG treatment.
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I have a chronic infectious disease like HIV or active hepatitis.
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I do not have severe neuropathy, heart attacks, active mental health issues, dementia, foot ulcers, major diabetes issues, amputations, or kidney disease.
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I often have very low blood sugar without noticing.
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I have been vaccinated against TB or tested positive for TB exposure.
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I plan to start or change a medication soon that could affect my blood sugar levels.
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I have had active eye disease due to diabetes.
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I have been in a trial for Type 1 Diabetes treatment before.
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I am currently on high dose steroids or might need them soon.
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I have a history of tuberculosis or a positive TB blood test.
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I have chronic kidney issues or significant diabetes complications.
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I've been hospitalized more than once for diabetic ketoacidosis in the last 3 months.
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I was diagnosed with diabetes before turning 1 year old.
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I have type 2 diabetes or severe obesity.
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I have a history of lupus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 2, 3, 4, and 5 years after initial bcg/placebo injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2, 3, 4, and 5 years after initial bcg/placebo injection
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Body Weight Changes
Secondary study objectives
Change in C-peptide
Change in adjusted HbA1c
Change in hypoglycemia
+1 moreOther study objectives
Exploratory: Change in autoantibodies
Inflammation
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bacillus Calmette-GuérinExperimental Treatment1 Intervention
2 BCG vaccinations spaced 4 weeks apart at the beginning of the trial
Group II: Saline InjectionPlacebo Group1 Intervention
2 placebo injections spaced 4 weeks apart at the beginning of the trial
Find a Location
Who is running the clinical trial?
NYU Langone HealthOTHER
1,408 Previous Clinical Trials
855,593 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,010 Previous Clinical Trials
13,308,857 Total Patients Enrolled
Siham Accacha, MDPrincipal InvestigatorNYU-Langone
2 Previous Clinical Trials
62 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure is higher than what's typical for my age and sex.I haven't taken diabetes medication not listed in the criteria in the last 90 days.You have had keloid scars in the past.I have antibodies linked to diabetes.I am willing and able to take 3 insulin injections daily with meals during the trial.I have other health conditions that could worsen with treatment.I am currently taking more than 160 mg of aspirin daily or using NSAIDs every day.I have been diagnosed with a form of diabetes caused by a single gene.I have diabetes because of my cystic fibrosis.I often have very low blood sugar without noticing.I am between 12 and 18 years old and will be under 18 when the study starts.My average blood sugar level over the past 3 months was either below 7% or above 9%.I have diabetes without specific autoantibodies.Your current weight is either extremely low or extremely high for someone your height.I am pregnant, breastfeeding, planning to become pregnant, or not using birth control.I am not on antibiotics that affect BCG treatment.I was diagnosed with cancer within the last 5 years.I have a condition that affects the production or lifespan of my red blood cells.I have a chronic infectious disease like HIV or active hepatitis.I do not have severe neuropathy, heart attacks, active mental health issues, dementia, foot ulcers, major diabetes issues, amputations, or kidney disease.I have been vaccinated against TB or tested positive for TB exposure.I plan to start or change a medication soon that could affect my blood sugar levels.I have been a Type 1 diabetic for over 2 years and am on insulin.I use a daily insulin pump or injections for my diabetes.You don't have HIV, tuberculosis, or pregnancy.You have a history of frequently going to the hospital because you didn't follow medical advice for a condition called ketoacidosis.You were not born in the US or in a country where BCG vaccinations are required.I have had active eye disease due to diabetes.I am taking or plan to take oral medication for type 2 diabetes.My blood tests are normal, except for a slight increase in creatinine.I have been in a trial for Type 1 Diabetes treatment before.Your C-peptide level is between 1.5 pmol/L and 300 pmol/L.Your body temperature is higher than 98.6 degrees Fahrenheit.Your heart beats too fast or too slow.I am currently on high dose steroids or might need them soon.I have a history of tuberculosis or a positive TB blood test.I was diagnosed with type 1 diabetes according to WHO/ADA guidelines.I have chronic kidney issues or significant diabetes complications.I live with someone who has a weak immune system or is at high risk for infections.I've been hospitalized more than once for diabetic ketoacidosis in the last 3 months.I was diagnosed with diabetes before turning 1 year old.You are currently in another clinical trial testing a new treatment for diabetes.I have type 2 diabetes or severe obesity.I have a history of lupus.
Research Study Groups:
This trial has the following groups:- Group 1: Bacillus Calmette-Guérin
- Group 2: Saline Injection
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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