Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity

Study Overview
=================
Brief Summary
-----------------
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 AFF008 will be involved and will be receive one boost immunization with AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved. In addition, up to 8 patients will be offered participation within an untreated control group.

Official Title
-----------------
Phase IB Follow-up, Randomized, Controlled, Parallel Group, Patient-blinded, Single-center Study to Assess One Boost With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological + Clinical Activity in Patients Who Have Received the Vaccine Within the Study AFF008

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Biological: AFFITOPE® PD01A
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prior participation in AFF008 and AFF008E Written informed consent signed and dated by the patient and the caregiver (caregiver is not mandatory) 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 Stable doses of PD medications for at least 3 months prior to Visit 0 and during the entire trial period and of all other medications 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 (except AFF008E) within 3 months before Visit 0 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: basal cell carcinoma, intraepithelial cervical neoplasia) Active infectious disease Immunodeficiency Significant systemic illness or psychiatric illness Alcoholism or substance abuse Prior treatment with experimental immunotherapeutics for PD including IVIG (with the exception of AFFITOPE ® PD01A), with immunosuppressive drugs or treatment with deep brain stimulation Venous status rendering it impossible to place an i.v. access

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: AFFITOPE® PD01A + Adjuvant<br>one injection of 15µg AFFITOPE® PD01A/ adjuvanted | Biological: AFFITOPE® PD01A<br>* s.c. injection<br>|
| Experimental: B: AFFITOPE® PD01A + Adjuvant<br>one injection of 75µg AFFITOPE® PD01A/ adjuvanted | Biological: AFFITOPE® PD01A<br>* s.c. injection<br>|
| Other: Control<br>Untreated control group | Other: Control<br>* Untreated control group<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability | Occurrence of any Adverse Events (AE) Occurrence of any Serious Adverse Events (SAE) Withdrawal criteria (number of patients who withdraw due to AEs/ reason for withdrawal) | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological | - Titer of antibodies specific for the immunizing peptide, KLH (keyhole limpet hemocyanin; carrier protein), aSynuclein (aSyn), bSyn, aggregated aSyn as assessed by ELlSA, FACS (or equivalent methods) | 6 month |