Last updated on December 2018

MER3101: MAS-1 Adjuvanted Antigen-specific Immunotherapeutic for Prevention and Treatment of Type 1 Diabetes

Brief description of study

The study is a randomized, double-masked, placebo-controlled, Phase 1 dose-escalation clinical trial. The objective of the trial is to determine if IBC adjuvanted with MAS-1 is safe and will favor tolerogenic pathways to restore immunologic balance and reverse T1D autoimmunity.

Detailed Study Description

In this four-arm (cohort) study, subjects (5 active MER3101 per arm plus 2 MAS-1 placebo) will be randomized to receive two intramuscular doses at days 1 and 28. Subjects will receive either MAS-1 placebo emulsion, or MAS-1 adjuvanted IBC at 33, 109 and 327 g IBC in 0.25 mL MAS-1 adjuvanted emulsion, followed by an additional arm to receive the maximum safe IBC dose selected from the first 3 arms in an increased dose volume of 0.5 mL MAS-1 emulsion and 2 subjects to receive 0.5 mL MAS-1 placebo control emulsion. All groups will receive standard intensive diabetes treatment with insulin and dietary management. The primary endpoint is to assess the safety and tolerability of 3 doses of progressively higher IBC antigen doses of the vaccine, and at 2 dose volumes (0.25 and 0.5 mL) of MAS-1 adjuvant emulsion at the maximum safe dose of IBC antigen. In addition, to determine if the vaccine induces a shift towards protection shown by increased levels of IL-4, IL-5, IL-10 and TGF-b and regulatory changes in insulin-specific T and B cells using novel reagents to detect these unique populations of cells in treated subjects.

Clinical Study Identifier: NCT03624062

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Recruitment Status: Open

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