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The therapeutic vaccine candidate, CV-MG01 comprises two short synthetic peptides separately conjugated to a carrier protein for the potential treatment of myasthenia gravis

3 consecutive subcutaneous injections of CV-MG01. The three injections are planned for each patient on Days 1, 29 (+/- 3 days) and 85 (+/- 7 days), respectively.

Two dose levels: low and high dose.

CV-MG01

3 consecutive subcutaneous injections of placebo. The three injections are planned for each patient on Days 1, 29 (+/- 3 days) and 85 (+/- 7 days), respectively.

Placebo

Rudy Mercelis, MD, PhD

Study CV-0002 is the first clinical trial administering CV-MG01 in humans. This clinical trial is a safety and proof-of-concept study (proof of mechanism of action) intended to assess the safety, tolerability and immunogenic response following 3 subcutaneous injections of CV-MG01 as a potential therapeutic vaccine / active immunotherapy in myasthenia gravis (MG) patients.

Part A of the trial has been designed as a human safety pharmacology and therapeutic exploratory, parallel group, randomised, placebo-controlled, single centre, Investigator and subject-blind study using adaptive dose and sample size approaches.

At the end of part A of the present study, all patients, including those receiving placebo, will be monitored in an open label, long-term safety follow-up part B of the study to assess the treatment effects over time.

Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia Gravis

A First-in-human and Proof-of-concept Study to Assess the Safety, Tolerability and Immunogenic Response of CV-MG01, Acetylcholine Receptor Mimetic Peptides, as Potential Therapeutic Vaccine, in Patients With Myasthenia Gravis

To explore changes in the humoral and cellular immune responses.

Safety assessed by laboratory tests, vital signs, electrocardiogram (ECG), adverse events, assessment of local tolerance, physical exams

To assess the immunogenic response after subcutaneous injections of CV-MG01 on the plasma levels of anti-peptide antibodies.

To assess the effect of CV-MG01 subcutaneous injections on the plasma level of acetylcholine receptor antibodies.

Clinical efficacy assessed by Quantitative MG testing Procedure extended with MG Composite Scale and MG-ADL (myasthenia gravis activities of daily living)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia Gravis	NCT02609022	Myasthenia Grav...	CV-MG01 Placebo	18 Years - 64 Years	CuraVac
Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia Gravis	NCT02609022	Myasthenia Grav...	CV-MG01 Placebo	18 Years - 64 Years	CuraVac
Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia Gravis	NCT02609022	Myasthenia Grav...	CV-MG01 Placebo	18 Years - 64 Years	CuraVac

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