Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA)

Phase IB Follow-up, Controlled, Parallel Group, Single-center Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological and Clinical Activity in Patients Who Have Participated in the AFF008 Program

This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A vaccinations in patients with Parkinson's disease. Patients, who have already participated in the AFF008 program will be involved and will receive a second boost immunization with AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved.

In addition, up to 6 patients will be offered participation within an untreated control Group.

Inclusion Criteria:

• Prior participation in AFF008, AFF008E and AFF008A
• Written informed consent signed and dated by the patient and, preferentially, the caregiver
• In the investigator's opinion, does not have visual or auditory impairments that would reduce the patients' ability to complete study questionnaires or be unable to receive instructions for These
• Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method
• All changes in conventional PD therapies must be available to the sponsor; in particular pharmacologic symptomatic PD medication allowing transformation to a Levodopa standard dose
• A potential participant should be on stable doses of all medications he/she is taking because of consisting illnesses according to medical history (except PD therapies, these will be recorded separately) for at least 30 days prior to Visit 1 if considered relevant by the investigator

Exclusion Criteria:

• Women of childbearing potential without birth control or pregnant women
• Participation in another clinical trial within 3 months before Visit 1 (except AFF008A)
• History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
• Autoimmune disease or allergy to components of the vaccine
• History of cancer (Exceptions: non-melanoma skin cancer, intraepithelial cervical neoplasia)
• Active infectious disease (e.g., Hepatitis B, C)
• Immunodeficiency
• Significant systemic illness
• Alcoholism or substance abuse
• Prior and/or current treatment with experimental immunotherapeutics including IVIG with the exception of AFFITOPE® PD01A, with immune modulating drugs or treatment with deep brain stimulation
• Venous status rendering it impossible to place an i.v. access