Study AFF011 is a randomized controlled parallel Group phase I study to investigate the safety and tolerability of two doses of the vaccine AFFITOPE® PD03A given to patients with early Parkinson's disease. In total 36 patients will be enrolled in 3 independent groups (2 treatment groups, 1 Placebo group), each consisting of 12 patients. The patients will be randomized to either receive 15µg or 75µg AFFITOPE® PD03A formulated with adjuvant or the reference substance without active component (Placebo). Over a study duration of 52 weeks, the study participants receive 4 injections as basic immunization in a 4-weekly interval and 1 boost immunization 36 weeks after the first injection. Male and female patients aged 45 to 70 years can participate in the trial. 2 study sites in Austria (Innsbruck and Vienna) will be involved. AFF011 is part of a project SYMPATH funded by the European Commission (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
s.c. injection
s.c. injection
s.c. injection
Medical University Innsbruck, Department of Neurology
Innsbruck, Austria
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität -Privatklinik Josefstadt
Vienna, Austria
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 Adverse Events and Serious Adverse Events
Evaluation of Adverse Events and Serious Adverse Events in regards to autoimmune reactions
Time frame: 12 months
New findings or Change in pre-existing findings assessed in physical and neurological examinations over time (study period)
Time frame: 12 months
Change in vital signs and Body mass over time (study period)
The Evaluation of vital signs includes the changes in blood pressure, heart rate, respiratory rate and Body temperature over time (measured at each visit).
Time frame: 12 months
Safety related Evaluation of MRI results of patients' brain after visit 5 and visit 8 compared to baseline
MRI safety measures will e.g. include the occurrence of inflammatory reactions (meningoencephalitis), new/changed hemorrhages and lacunar infarcts.
Time frame: 12 months
Clinical significance/changes in laboratory parameters over time (study period)
Laboratory assessment includes hematology, biochemistry, coagulation, serology and urinanalysis.
Time frame: 12 months
Immunological activity of AFFITOPE® vaccine PD03A
Titer of vaccination induced antibodies directed towards vaccine components, alpha- and beta synuclein
Time frame: 12 months
Change in motor symptoms at visit 8 and visit 11 compared to baseline
Change in motor symptoms: MDS Unified Parkinson's Disease Rating Scale (UPDRS) II and III
Time frame: 12 months
Change in non-motor symptoms at visit 8 and visit 11 compared to baseline
Change in non-motor symptoms: PDQ-39 (Parkinson's Disease Quality of Life-39)/PD non-motor symptom score, MDS UPDRS I (Movement Disorder Society Unified Parkinson's Disease Rating scale), cognitive test battery, HAM-D (Hamilton Depression Rating Scale)
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.