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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02609022
• Date of registration: 13/11/2015
• Prospective Registration: Yes
• Primary sponsor: CuraVac
• Public title: Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia Gravis
• Scientific title: 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
• Date of first enrolment: March 2016
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02609022
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

Belgium

Contacts

• Name: Rudy Mercelis, MD, PhD
• Affiliation: University Hospital, Antwerp

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female subjects, with ocular and generalised myasthenia gravis (grade 1-2-3).

- Between the ages of 18 and 64 years, inclusive, at the time of the first injection.

- A Body Mass Index (BMI) between 18 and 35 kg/m2, inclusive.

- Patient with positive antibodies to AChR based on radioimmunoassay(RIA) (AChRAb = 1
nmol/l); if available, historical data on AChR Ab levels over the last 2 years will be
collected in the study records.

- Patient may use corticosteroid treatment, equivalent to a daily dose of 30 mg
prednisone or lower and stable (dose +/- 5 mg) during the 3 months before
participation.

- Patient may use one immunosuppressive drug with or without concomitant use of
corticosteroid, providing that the dosage has been stable/unchanged for 3 months
before participation.

- Blood pressure and heart rate (supine & standing) within normal reference range for
the population or investigator site, or results with acceptable deviations that are
judged to be not clinically significant by the investigator.

- Venous access sufficient to allow blood sampling as per the protocol.

- Are reliable and willing to make themselves available for the duration of the study
and are willing to follow study procedures.

- Have given written informed consent approved by the relevant Ethics Committee (EC)
governing the site.

Exclusion Criteria:

- MG patients of Grade 4 or 5 based on myasthenia gravis foundation of America (MGFA)
classification.

- Patients with history or presence of a primary or recurrent malignant disease
including the presence or history of a thymoma.

- Thymectomy planned during part A of the study period or performed within 1 year prior
to the first dose of study vaccine.

- Any confirmed or suspected immunosuppressive or immunodeficient condition not related
to the treatment of MG, including human immunodeficiency virus (HIV) infection, or a
family history of congenital or hereditary immunodeficiency.

- History or evidence of administration of immunoglobulins and/or any blood products
within 3 months prior to the first dose of study vaccine or a planned administration
of immunoglobulins during the first 3 months of the trial.

- History or evidence of rituximab treatment within 6 months prior to first dose of
study vaccine.

- History or evidence of plasmapheresis within 3 months prior to the first dose of study
vaccine or a planned plasmapheresis during the first 3 months of the trial.

- At high risk for aspiration.

- Pulmonary: forced vital capacity reduced to less than 70% of predicted capacity.

- History of severe allergic disease or reactions likely to be exacerbated by any
component of the vaccine.

- History or evidence of Lambert-Eaton myasthenic syndrome, drug-induced myasthenia
gravis, hereditary forms of myasthenic syndrome.

- History of relevant chronic degenerative, psychiatric, or neurological disorder other
than MG.

- Severe hepatic, renal or cardiac insufficiency.

- Major congenital defects or serious chronic illness other than MG.

- Positive pregnancy test or desire to become pregnant during the study.

- Female patients of child-bearing potential that do not use a reliable and highly
effective method of contraception at least one month before first injection, during
the study and until 3 months after the last injection.

- Any significant out-of-range Clinical Laboratory results considered as clinically
significant according to Investigator's judgment.

- Previous completion or withdrawal from this study.

- Sponsor employees or investigator site personnel directly affiliated with this study,
and their immediate families. Immediate family is defined as a spouse, parent, child
or sibling, whether biological or legally adopted.

- Any medical condition that, in the opinion of the Investigator, might interfere with
the subject's participation in the study, poses any added risk for the subject, or
confounds the assessment of the subjects.



Age minimum: 18 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Myasthenia Gravis

Intervention(s)

Biological: CV-MG01

Biological: Placebo

Primary Outcome(s)

Immunogenicity [Time Frame: End of study part A (38 weeks)]

Safety [Time Frame: End of study part A (38 weeks)]

Secondary Outcome(s)

Clinical efficacy [Time Frame: End of study part A (38 weeks)]

Biomarker [Time Frame: End of study part A (38 weeks)]

Secondary ID(s)

CV-0002

2015-002880-41

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Leiden University Medical Center

Aepodia

University Hospital, Antwerp