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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~1, 2, 3, 4, and 5 years after initial bcg/placebo injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2, 3, 4, and 5 years after initial bcg/placebo injection for reporting.

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 more
Other 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
1,415 Previous Clinical Trials
856,227 Total Patients Enrolled
18 Trials studying Diabetes
20,252 Patients Enrolled for Diabetes
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,670 Total Patients Enrolled
11 Trials studying Diabetes
269,596 Patients Enrolled for Diabetes
Siham Accacha, MDPrincipal InvestigatorNYU-Langone
2 Previous Clinical Trials
62 Total Patients Enrolled
Denise L Faustman, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
250 Total Patients Enrolled

Media Library

Bacillus Calmette-Guérin (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05180591 — Phase 2
Diabetes Research Study Groups: Bacillus Calmette-Guérin, Saline Injection
Diabetes Clinical Trial 2023: Bacillus Calmette-Guérin Highlights & Side Effects. Trial Name: NCT05180591 — Phase 2
Bacillus Calmette-Guérin (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05180591 — Phase 2
~66 spots leftby Mar 2027
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