This is a randomized controlled parallel Group phase I study to investigate the safety and immunological/ therapeutic activity of two new vaccines, AFFITOPE® PD01A and AFFITOPE® PD03A, given to patients with early Multiple System Atrophy (MSA). In total 30 patients are planned to be enrolled in the study: 12 patients in each treatment arm who will receive either 75µg AFFITOPE® PD01A (with adjuvant) or 75µg AFFITOPE® PD03A (with adjuvant) and 6 patients in the control group who will receive the reference substance (Placebo). Over a study duration of 52 weeks, the study participants will 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 30 to 75 years can participate in the trial. 2 study sites in France (Bordeaux and Toulouse) will be involved. AFF009 is part of the 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
30
s.c. injection
s.c. injection
s.c. injection
University Hospital Bordeaux (Pellegrin Hospital)
Bordeaux, France
University Hospital Toulouse
Toulouse, France
Number of patients who withdraw due to Adverse Events (AEs)
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
Physical Examination
New findings or change in pre-existing findings assessed in physical examinations over time (study period)
Time frame: 12 months
Vital signs
Change in vital signs. The Evaluation 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
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
Body mass
Change of Body mass over time (study period)
Time frame: 12 months
Neurological Examination
New findings or change in pre-existing findings assessed in neurological examinations over time (study period)
Time frame: 12 months
Immunological activity of AFFITOPE® vaccines PD01A and PD03A.
Titer of vaccination induced antibodies directed towards vaccine components, alpha- and beta synuclein
Time frame: 12 months
Change in motor symptoms at Visit 5 and Visit 8 compared to baseline
Change in Motor symptoms: UMSARS II (Unified Multiple System Atrophy Rating Scale), CGI (Clinical Global Impression Improvement scale)
Time frame: 12 months
Change in non-motor symptoms at Visit 5 and Visit 8 compared to baseline
Change in non-motor symptoms: UMSARS I and IV, GDS (Geriatric Depression Scale), COMPASS 31 (Composite Autonomic Symptom Score), MSA-QoL (MSA- Quality of life scale), MOCA (Montreal cognitive assessment), autonomic testing of cardiovascular function
Time frame: 12 months
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