MAS-1 Adjuvanted Immunotherapy for Type 1 Diabetes
(MER3101 Trial)
Trial Summary
What is the purpose of this trial?
This trial tests a new vaccine mixed with a booster substance to help patients with type 1 diabetes. The goal is to retrain their immune system to stop attacking insulin-producing cells, potentially improving their condition.
Do I need to stop my current medications for the trial?
The trial requires that you do not use medications that influence glucose tolerance or systemic immunosuppressants. If you are using non-insulin drugs to control blood sugar, you will need to stop those as well.
What data supports the effectiveness of the MAS-1 adjuvanted immunotherapy treatment for type 1 diabetes?
Research shows that MAS-1 adjuvanted immunotherapy can generate strong immune responses that help prevent diabetes in mice, with a significant number remaining diabetes-free for up to a year. Additionally, insulin B-chain immunotherapy has been effective in reducing diabetes incidence in animal models, suggesting potential benefits for type 1 diabetes.12345
Is MAS-1 adjuvanted immunotherapy safe for humans?
How is the MAS-1 adjuvanted Insulin B-chain treatment different from other treatments for type 1 diabetes?
The MAS-1 adjuvanted Insulin B-chain treatment is unique because it uses a nanoparticular, emulsion-based adjuvant (a substance that enhances the body's immune response to an antigen) to promote Th2 and regulatory immune responses, which can provide long-term protection against type 1 diabetes. This approach focuses on modulating the immune system rather than directly affecting blood sugar levels, which is different from standard insulin therapies.12347
Research Team
Peter Gottlieb, MD
Principal Investigator
University of Colorado, Denver
Eligibility Criteria
This trial is for adults aged 18-45 with Type 1 Diabetes diagnosed in the last 2 years, positive for an islet cell autoantibody, and have certain levels of C-peptide. Participants must not be pregnant or planning pregnancy soon, avoid other vaccines initially, and manage diabetes intensively. Exclusions include those with significant complications or infections, drug sensitivities, or unwilling to use birth control.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive two intramuscular doses at days 0 and 28 of either MAS-1 placebo emulsion or MAS-1 adjuvanted IBC at varying doses
Follow-up
Participants are monitored for safety and effectiveness after treatment, including immunologic analysis and monitoring of adverse events
Treatment Details
Interventions
- MAS-1 adjuvanted Insulin B-chain (Immunotherapy)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborator
Nova Immunotherapeutics Limited
Industry Sponsor