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Myasthenia GravisPhase 1/2NCT02609022

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

A Phase 1/2 study testing CV-MG01 in people with Myasthenia Gravis, run by CuraVac at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 /… Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Myasthenia Gravis
What is being tested?
CV-MG01
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteBelgium
Study dates
Mar 2016to 30 Sep 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • University Hospital, Antwerp

    Edegem, Antwerp, 2650

Other trials in Belgium

About this study

Official 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

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.

Read the detailed description

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.

Being tested
CV-MG01, Placebo
Keywords
Myasthenia Gravis, CV-MG01 therapeutic vaccine, Acetylcholine receptor mimetic peptides, Safety, Immunogenic response, First-in-Human, Proof-of-Concept, Myasterix
Medical subject headings
Myasthenia Gravis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CV-MG01Biological

    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.

  • PlaceboBiological

    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.

Study groups in NCT02609022
Study groupRoleWhat they receive
CV-MG01ExperimentalThe therapeutic vaccine candidate, CV-MG01 comprises two short synthetic peptides separately conjugated to a carrier protein for the potential treatment of myasthenia gravis
Receives: Biological: CV-MG01
PlaceboPlacebo comparatorAluminium hydroxide adjuvant alone
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

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

    Measured: End of study part A (38 weeks)

  2. Immunogenicity

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

    Measured: End of study part A (38 weeks)

Secondary outcomes (2)

  1. Biomarker

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

    Measured: End of study part A (38 weeks)

  2. Clinical efficacy

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

    Measured: End of study part A (38 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2015 (estimated)
  2. Study startMar 2016
  3. Primary completion30 Sep 2018
  4. Study completion30 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02609022
Sponsor's protocol ID
CV-0002
Other IDs
2015-002880-41, 2015
Status last verified
Jan 2019
First submitted
13 Nov 2015
Last updated
28 Jan 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Weathington NM, Blalock JE. Rational design of peptide vaccines for autoimmune disease: harnessing molecular recognition to fix a broken network. Expert Rev Vaccines. 2003 Feb;2(1):61-73. doi: 10.1586/14760584.2.1.61.

    PubMed 12901598

  • Galin FS, Chrisman CL, Cook JR Jr, Xu L, Jackson PL, Noerager BD, Weathington NM, Blalock JE. Possible therapeutic vaccines for canine myasthenia gravis: implications for the human disease and associated fatigue. Brain Behav Immun. 2007 Mar;21(3):323-31. doi: 10.1016/j.bbi.2006.10.001. Epub 2006 Nov 20.

    PubMed 17113748

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CV-MG01 in people with Myasthenia Gravis, run by CuraVac at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: End of study part A (38 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02609022, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2019.

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