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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Biological: AFFITOPE® PD01A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AFFITOPE® PD01A + Adjuvant<br>one injection of 75µg AFFITOPE® PD01A/adjuvanted | Biological: AFFITOPE® PD01A<br>* s.c. injection<br>|
| No Intervention: Control<br>Untreated control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of any Serious Adverse Events (SAE) that are related to the study drug |  | 12 months | 
| Number of patients who withdraw due to Adverse Events (AEs) | The withdrawal criteria (continuation decision) in regards to the number of patients who withdraw due to AEs as well as the reason for withdrawal will be evaluated. | 12 months | 
| Occurrence of any Grade 3 or higher AEs related to the study drug within 4 weeks after vaccination |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological activity of AFFITOPE® vaccine PD01A | Titer of vaccination induced antibodies directed towards vaccine components and the target (native aSyn) assessed by ELISA (or equivalent method) | 12 months |