MER3101: MAS-1 Adjuvanted Antigen-specific Immunotherapeutic for Prevention and Treatment of Type 1 Diabetes (MER3101)
Type 1 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring New onset
Eligibility Criteria
Inclusion Criteria:
- 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.
- Type 1-diabetes mellitus diagnosed within the previous 2 years
- 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
- At least one month from last immunization
- Must be willing to comply with intensive diabetes management
- 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.
- 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)
- Subjects must have HbA1c levels under 9.5 to be enrolled in the study.
- 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:
- Be currently pregnant or lactating, or anticipate getting pregnant during the treatment period until 2 months after the last study drug administration.
- Ongoing use of medications known to influence glucose tolerance
- Require use of systemic immunosuppressant(s)
- Any significant diabetes complications such as renal disease (proteinuria or elevated Cr) and diabetic retinopathy
- Have a history of malignancies
- Be currently using non-insulin pharmaceuticals to affect glycemic control
- 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.
- Inability or unwillingness to comply with the provisions of this protocol
- Have an active infection or positive tuberculosis test result.
- Have serologic evidence of current or past HIV, Hep B, or Hep C infection.
- Have a known history of hypersensitivity or allergy reactions to squalane or squalene based adjuvants or other components of the study immunogen
- Subjects with a history or evidence of chronic kidney disease (serum creatinine> 1.5mg/dL)
- Subjects with a history of proliferative diabetic retinopathy that has not been treated with laser therapy
- Subjects with a history of neuropathy, foot ulcers, amputations, or kidney disease
- 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.
- Have current, confirmed COVID-19 infection
Sites / Locations
- University of Colorado, DenverRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Other
Other
Other
Other
33 ug IBC in 0.25 mL MAS-1 emulsion
109 ug IBC in 0.25 mL MAS-1 emulsion
327 ug IBC in 0.25 mL MAS-1 emulsion
TBD ug IBC in 0.5 mL MAS-1 emulsion
7 participants to be randomized between placebo and MAS-1 adjuvanted insulin B-chain (2:5) with a 33 ug IBC dose in 0.25 mL MAS-1 emulsion
7 participants to be randomized between placebo and MAS-1 adjuvanted insulin B-chain (2:5) with a 109 ug IBC dose in 0.25 mL MAS-1 emulsion
7 participants to be randomized between placebo and MAS-1 adjuvanted insulin B-chain (2:5) with a 327 ug IBC dose in 0.25 mL MAS-1 emulsion
7 participants to be randomized between placebo and MAS-1 adjuvanted insulin B-chain (2:5) with the maximum safe IBC dose selected from the first 3 groups (either 33 µg, or 109 µg, or 327 µg IBC) in 0.5 mL MAS-1 emulsion