drugset / Trial / NCT02609022
Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia Gravis
Phase 1/2
Completed
24 enrolled
CuraVac
Aepodia · collabLeiden University Medical Center · collabUniversity Hospital, Antwerp · collab
RandomizedParallel-groupQuadruple-blindTreatment
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 / active immunotherapy in myasthenia gravis (MG) patients.
Timeline
- Start
- 2016-03
- Primary completion
- 2018-09-30
- Completion
- 2018-09-30
Publications
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CV-MG01 | Vaccine | — | Subcutaneous |