This is a phase I study to assess the tolerability and safety of 4 injections of two different doses of AFFITOPE® PD01A formulated with an adjuvant to patients with early Parkinson's disease in male and female patients aged 45 to 65 years (or age between 40 and 45 years if there is no evidence for genetic forms of the disease and the diagnosis of idiopathic Parkinson's disease was confirmed, after approval by Sponsor). One study site in Vienna (Austria) will be involved. Each patient's participation will last 1 year. In addition, up to 8 patients will be offered participation within an untreated control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
s.c. injection
Untreated control
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32, 1080 Vienna
Vienna, Austria
Tolerability/Safety
* Occurrence of any AE (including a clinical grading scale of AEs according to NCI-CTCAE Version 4.02 (2009) for assessments of AEs + toxicity and including a grading of local injection site reactions according to the FDA Guidance for Industry: Toxicity Scale for Healthy Adult and Adolescents Patients Enrolled in Preventive Vaccine Clinical Trials (2007)) * Occurrence of any SAE * Withdrawal criteria (number of patients who withdraw due to AEs/ reason for withdrawal)
Time frame: 12 month
Immunological
\- Titer of vaccination induced antibodies directed towards vaccine components, alpha- and beta synuclein
Time frame: 12 month
Clinical Activity
* Change in motor symptoms (MDS-UPDRS III) * Change in non-motor PD symptoms (e.g.; MDS-UPDRS Ia, II, PDQ39, cognition) * Change in biological and radiological markers (e.g. CSF alpha synuclein levels)
Time frame: 12 month
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