Can a Vaccine-Like shot tame type 1 diabetes?
NCT ID NCT03624062
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new treatment called IBC with MAS-1 in 21 adults recently diagnosed with type 1 diabetes. The goal was to see if it is safe and can retrain the immune system to stop attacking the pancreas, potentially helping the body control blood sugar naturally. Participants received either the treatment or a placebo, and researchers monitored side effects and immune system changes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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21 people
The number who actually took part.
- Started
-
Aug 2020
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Be between the ages of 18 and 45 years of age who meet the ADA standard T1DM criteria and are positive for at least 1 islet cell autoantibody. 2. Type 1-diabetes mellitus diagnosed within the previous 2 years at time of screening 3. Must have stimulated C-peptide levels ≥ 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes and within one month (37 days) of randomization 4. At least one month from last immunization 5. Must be willing to comply with intensive diabetes management 6. If participant is female with reproductive potential, she must have a negative pregnancy test and be willing to avoid pregnancy during the treatment period until 2 months after the last study drug administration. 7. Willing to forgo routine clinical immunizations during the first 100 days after initial study drug administration (COVID-19 vaccination is permitted 60 days following initial study drug administration) 8. Subjects must have HbA1c levels under 9.5 to be enrolled in the study. 9. At least 30 days from receiving a single dose COVID-19 vaccine or at least 30 days from completing a multi-dose COVID-19 vaccine series. Exclusion Criteria: 1. Be currently pregnant or lactating, or anticipate getting pregnant during the treatment period until 2 months after the last study drug administration. 2. Ongoing use of medications known to influence glucose tolerance 3. Require use of systemic immunosuppressant(s) 4. Any significant diabetes complications such as renal disease (proteinuria or elevated Cr) and diabetic retinopathy 5. Have a history of malignancies 6. Be currently using non-insulin pharmaceuticals to affect glycemic control 7. Have any acute or chronic complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk including neurological abnormalities. 8. Inability or unwillingness to comply with the provisions of this protocol 9. Have an active infection or positive tuberculosis test result. 10. Have serologic evidence of current or past HIV, Hep B, or Hep C infection. 11. Have a known history of hypersensitivity or allergy reactions to squalane or squalene based adjuvants or other components of the study immunogen 12. Subjects with a history or evidence of chronic kidney disease (serum creatinine\> 1.5mg/dL) 13. Subjects with a history of proliferative diabetic retinopathy that has not been treated with laser therapy 14. Subjects with a history of neuropathy, foot ulcers, amputations, or kidney disease 15. Males of reproductive potential who are unwilling to use acceptable birth control during the treatment period through 2 months after the last study drug administration, unless the female partner is postmenopausal or surgically sterile. 16. Have current, confirmed COVID-19 infection
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Colorado, Denver
Aurora, Colorado, 80045, United States
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Other studies related to the condition(s) this trial covers.
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