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Vaccine
BCG Vaccinations for Type 1 Diabetes in Children
Phase 2
Recruiting
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
Ongoing daily treatment with insulin prior to the screening visit
Presence of one or more of the following: 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2, 3, 4, and 5 years after initial bcg/placebo injection
Awards & highlights
Study Summary
This trial will look at if repeat BCG shots could help treat Type 1 diabetes in kids.
Who is the study for?
Children aged 8 to less than 18 with new onset Type 1 diabetes, diagnosed between 3-12 months ago. They must not have HIV, TB, or be pregnant and should have normal blood tests except for mild creatinine elevation. Participants need to be able to monitor their glucose levels and commit to the study protocol.Check my eligibility
What is being tested?
The trial is testing whether repeated vaccinations with Bacillus Calmette-Guérin (BCG) can positively affect the immune system and metabolism in children who recently developed Type 1 diabetes.See study design
What are the potential side effects?
Possible side effects of BCG vaccination include soreness at injection site, low-grade fever, and swelling of lymph nodes near the injection area. Rarely, more serious reactions like an abscess or bone inflammation could occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been using insulin daily before my screening visit.
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I have antibodies indicating an autoimmune response related to diabetes.
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I am between 8 and 17 years old.
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My blood tests are normal, except for a slight increase in creatinine.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in HbA1c values
Secondary outcome measures
Change in C-peptide
Change in insulin usage
Other outcome measures
Exploratory: Change in hypoglycemia
Side effects data
From 2015 Phase 4 trial • 4262 Patients • NCT0169410810%
BCG-vaccine related event
3%
Other than dead
1%
Other than BCG-vaccine related
100%
80%
60%
40%
20%
0%
Study treatment Arm
BCG-vaccine
Control Children (no Intervention)
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?
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,541 Total Patients Enrolled
10 Trials studying Diabetes
268,276 Patients Enrolled for Diabetes
Denise L Faustman, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
300 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of repeatedly going to the hospital for not following medical advice and getting a serious condition called ketoacidosis.You were not born in the US or in a country where BCG vaccinations are required.I plan to start or change a medication soon that could affect my blood sugar levels.I am not on high dose steroids or immunosuppressives, except for minor uses like nasal sprays or skin creams.I am on antibiotics that may affect BCG treatment.I have chronic kidney issues or significant diabetes complications.I have given my consent, and if applicable, my child has agreed to participate in the trial.I was diagnosed with Type 1 diabetes between 3 and 12 months ago.I have diabetes without any specific autoantibodies.You have been diagnosed with type 1 diabetes before joining the study, as confirmed by specific blood sugar levels.I have been in a trial for Type 1 diabetes treatment before.Your heart rate is not between 50 and 120 beats per minute.Your body mass index (BMI) is extremely low or extremely high for your age and height.I have a condition affecting my red blood cells, like anemia or sickle cell.I have been using insulin daily before my screening visit.I am taking more than 160 mg of aspirin daily or using NSAIDs every day.Your body temperature is higher than 98.6 degrees Fahrenheit.I have antibodies indicating an autoimmune response related to diabetes.I am between 8 and 17 years old.My blood tests are normal, except for a slight increase in creatinine.I do not have severe neuropathy, heart issues, serious mental health conditions, dementia, foot ulcers, uncontrolled diabetes, amputations, or kidney disease.I have had active eye disease due to diabetes.My blood pressure is higher than what's typical for my age and sex.I have been diagnosed with a form of diabetes caused by a single gene.I haven't taken diabetes medication not listed in the criteria in the last 90 days.I have a history of lupus.You are currently taking part in a clinical trial for BCG or other immunotherapy for diabetes.I have type 2 diabetes or severe obesity.I have been vaccinated against TB, or tested positive for TB exposure.I am taking or plan to take oral medication for type 2 diabetes.You have a history of developing keloids.You frequently have severe low blood sugar episodes and may not realize when your blood sugar is low.I've been hospitalized more than once for diabetic ketoacidosis in the last 3 months.I have a history of tuberculosis or a positive TB test.I have other health conditions that could worsen with treatment.I was diagnosed with cancer within the last 5 years.I have a chronic infectious disease like HIV or active hepatitis.You live with someone who has a weakened immune system or is at high risk for getting sick.I am not pregnant, breastfeeding, planning to become pregnant, or if of child-bearing potential, I am using effective contraception.You do not have HIV, tuberculosis, or pregnancy.I was diagnosed with diabetes before I turned 1 year old.I have diabetes because of my cystic fibrosis.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research project accepting those aged eighty-five and over as participants?
"To be eligible for this clinical trial, participants must have attained the age of 8 but not yet achieved their 18th birthday."
Answered by AI
What qualifications are necessary for someone to participate in this clinical experiment?
"This trial has a strict eligibility criteria, requiring that participants have diabetes and are aged between 8 to 17 years old. A total of 100 individuals will be admitted into the study."
Answered by AI
Are there currently any available vacancies for this clinical trial?
"This clinical trial is currently accepting applicants, as indicated by the data found on clinicaltrials.gov. First posted in May of 2023 and updated just days ago, this study is open for recruitment."
Answered by AI
Is the use of Bacillus Calmette-Guérin considered a secure option for individuals?
"Our experts at Power assigned Bacillus Calmette-Guérin a score of 2 on the safety scale as this is Phase 2 trial, meaning limited evidence exists to support its safety profile but none for efficacy."
Answered by AI
To what extent has recruitment for this clinical trial been successful?
"Affirmative, the information hosted on clinicaltrials.gov suggests that recruitment for this trial is going forward as planned. The study was originally posted online on May 4th and last modified a week later, with 100 patients needed from one site."
Answered by AI
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