Study Assessing Safety and Therapeutic Activity of AFFITOPE® PD01A and PD03A in Patients With Early MSA (AFF009)

This is an interventional treatment trial for Multiple System Atrophy Read More

Inclusion Criteria:

• Possible or probably MSA diagnosis (MSA-P or MSA-C) according to Gilman 2008 consensus criteria
• Onset of MSA symptoms less than 4 years
• Participants with an anticipated survival of at least 3 years in the opinion of the PI
• Written informed consent obtained prior to study entry
• MSA patient > 30 and < 75 years of age at time of study entry
• Female patients of childbearing potential using a medically accepted contraceptive method
• Stable medication for MSA symptoms (Levodopa, Dopamine agonists, Midodrine, Fludrocortisone, monoamine oxidase-B and Catechol-O-methyltransferase inhibitors; Antidepressants, Laxatives, NSAIDs or paracetamol as basic medication for pain in the musculoskeletal system)

Exclusion Criteria:

• Pregnant or lactating women
• Sexually active women of childbearing potential not using a medically accepted birth control method
• Patients with dementia (MOCA at Screening < 21)
• Speech impairment as assessed by a score of ≥ 3 on UMSARS question 1
• Swallowing impairment as assessed by a score of ≥ 3 on UMSARS question 2
• Impairment in ambulation as assessed by a score of ≥ 3 on UMSARS question 7
• History or evidence of any other central nervous system disorder like stroke, angioma and other relevant neurological diseases
• History of malignancy other than skin cancer during the last 5 years (if considered to be cured, patient might be included)
• Active or passive vaccination 4 weeks before the first vaccination on Day 0 and during the main study period ending on Day 280. Emergency vaccinations are acceptable
• Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the entire study period
• Subjects participating or have participated in another interventional clinical trial within 60 days prior to baseline
• Blood donation within 4 weeks prior to first vaccination.
• History of autoimmune diseases, severe hypersensitivity reactions and anaphylaxis, allergic bronchial asthma and severe allergic rhinoconjunctivitis
• Known hypersensitivity or allergic reaction to one of the components of the vaccine
• A family history of congenital or hereditary immunodeficiency
• Administration of chronic (defined as more than 14 days) immunosuppressant or other immune-modifying drugs within six months before first vaccination and during the entire study period. For corticosteroids like prednisone or equivalent ≥ 0.05 mg/kg/day. Topical and inhaled steroids are allowed
• Intake of non steroidal anti-inflammatory drugs (NSAIDs) or paracetamol more than the basic medication for pain in the musculoskeletal system within three days prior to a vaccination with AFFITOPE® PD01A or AFFITOPE® PD03A or Placebo
• If a patient shows an acute febrile infection (≥ 37.8° Celsius) on the day of vaccination, administration of Investigational Medicinal Product (IMP) should be postponed until resolution of the infection
• Infection with the human immunodeficiency virus (HIV, a negative test result within 30 days before screening is acceptable), Hepatitis B (HBsAg) or Hepatitis C
• Significant systemic illness (e.g. chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure and/or other deficiencies), if considered relevant by the investigator
• Venous status rendering it impossible to place an i.v. access
• Contraindications for MRI and lumbar puncture
• Not able to understand and comply with protocol requirements, instructions, protocol-stated restrictions
• Unwilling to provide informed consent. Exceptions for patients who are physically not able to provide written informed consent (e.g. legal representative, consent via voce with witness)