Tolerability and Safety of Subcutaneous Administration of Two Doses of AFFITOPE® PD01A in Early Parkinson's Disease

Exclusion Criteria

• •Women of childbearing potential without birth control or pregnant women
• •Participation in another clinical trial
• •Autoimmune disease or allergy to components of the vaccine
• •Contraindications for MRI, DAT-SPECT, colonoscopy including biopsy or lumbar puncture
• •Dementia
• •History of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia)
• •Active infectious disease
• •Immunodeficiency
• •Significant systemic illness or psychiatric illness
• •Parkinson-like disease secondary to drug therapy side effects
• •Parkinson-plus syndromes
• •Heredodegenerative disorders
• •Alcoholism or substance abuse
• •Prior treatment with experimental immunotherapeutics for PD including IVIG, with immunosuppressive drugs or treatment with deep brain stimulation
• •Venous status rendering it impossible to place an i.v. access