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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
26
s.c. injection
Studienzentrum der PROSENEX, AmbulatoriumsbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt
Vienna, Austria
Occurrence of any Serious Adverse Events (SAE) that are related to the study drug
Time frame: 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.
Time frame: 12 months
Occurrence of any Grade 3 or higher AEs related to the study drug within 4 weeks after vaccination
Time frame: 12 months
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)
Time frame: 12 months
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