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Immunotherapy

MAS-1 Adjuvanted Immunotherapy for Type 1 Diabetes (MER3101 Trial)

Phase 1
Recruiting
Led By Peter Gottlieb
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 43 months
Awards & highlights

MER3101 Trial Summary

This trial is testing if a new drug is safe and effective at treating type 1 diabetes.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests MAS-1 adjuvanted Insulin B-chain's safety and its ability to promote immune tolerance in Type 1 Diabetes. It's a randomized (participants are chosen by chance), double-masked (neither researchers nor participants know who gets the real treatment), placebo-controlled trial that gradually increases doses.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical reactions to immunotherapies such as injection site reactions, flu-like symptoms, allergic responses to components like squalane/squalene based adjuvants used in the vaccine formulation.

MER3101 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~43 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 43 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Immunologic Analysis
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary outcome measures
HbA1c value
Insulin Use
Mean C-peptide AUC value

MER3101 Trial Design

4Treatment groups
Experimental Treatment
Group I: TBD ug IBC in 0.25 mL MAS-1 emulsionExperimental Treatment1 Intervention
7 participants to be randomized between placebo and MAS-1 adjuvanted insulin B-chain (2:5) with the optimal IBC dose selected from the first 3 groups (either 33 µg, or 109 µg, or 327 µg IBC) in 0.25 mL MAS-1 emulsion
Group II: 33 ug IBC in 0.25 mL MAS-1 emulsionExperimental Treatment1 Intervention
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
Group III: 327 ug IBC in 0.25 mL MAS-1 emulsionExperimental Treatment1 Intervention
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
Group IV: 109 ug IBC in 0.25 mL MAS-1 emulsionExperimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,498 Total Patients Enrolled
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
57 Previous Clinical Trials
93,858 Total Patients Enrolled
Nova Immunotherapeutics LimitedIndustry Sponsor
1 Previous Clinical Trials
102 Total Patients Enrolled

Media Library

MAS-1 adjuvanted Insulin B-chain (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03624062 — Phase 1
Type 1 Diabetes Research Study Groups: TBD ug IBC in 0.25 mL MAS-1 emulsion, 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
Type 1 Diabetes Clinical Trial 2023: MAS-1 adjuvanted Insulin B-chain Highlights & Side Effects. Trial Name: NCT03624062 — Phase 1
MAS-1 adjuvanted Insulin B-chain (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03624062 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range for participants in this study inclusive of those above 35 years?

"According to the study's inclusions criteria, only those aged between 18 and 45 can participate. However, there are 228 trials for minors and 970 clinical studies catered toward seniors."

Answered by AI

Are there precedents for this treatment in the existing scientific literature?

"Currently, 71 investigations into this particular intervention are taking place. 13 of these experiments have reached the third and final phase of research. While Cincinnati is home to most trials exploring this treatment, 247 different medical centers across the United States are involved in its development."

Answered by AI

Are the potential risks of this therapy acceptable for patients?

"This therapy has only been tested on a limited basis, so it was awarded an initial safety rating of 1."

Answered by AI

Is there an ongoing recruitment of participants for this experiment?

"According to the public record on clinicaltrials.gov, this clinical trial is in an active recruitment phase and was initially listed at the end of August 2020 with its most recent update being published in May 2022."

Answered by AI

May I participate in this experiment?

"This medical trial is currently seeking 28 participants aged 18 to 45 with newly diagnosed diabetes mellitus. Additionally, the following criteria must be met: females of reproductive age require a negative pregnancy test and are obligated to abstain from conception until two months after study drug administration, ADA-approved T1DM diagnosis within the past 2 years, C-peptide levels ≥ 0.2 pmol/ml during an MMTT conducted 21 days post-diagnosis and before randomization, one month minimum since last immunization prior to enrolment in the clinical trial, intensive diabetes management compliant behaviour expected throughout duration of treatment; routine vaccinations prohibited for"

Answered by AI

How many participants are enrolled in this research program?

"Affirmative. Information hosted on clinicaltrials.gov indicates that this experiment, initially posted in August of 2020, is searching for 28 volunteers from 1 site to participate. The most recent update was May 4th 2022."

Answered by AI
~8 spots leftby Dec 2025