An unblinded, single arm, pilot observational study to test the safety, tolerability, immunogenicity and the biological effects of TRB-001 vaccination in individuals who have previously undergone aSyn immunotherapy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
This is an unblinded, single arm, pilot observational study to test the safety, tolerability, immunogenicity and the biological effects of TRB-001 vaccination in individuals who have previously undergone aSyn immunotherapy. After the screening period, all participants who are enrolled in the study will receive a first intradermal TRB-001 immunization at a dose of 100μg. Patients antibody response will be assessed at week two (compared to baseline). Based on the safety and immunogenicity results, the PI, Medical Monitor, and Sponsor will decide on a potential second immunization with TRB-001. Regarding immunogenicity, a predefined cut-off will be used. The patient may be offered another injection to be applied 4-6 weeks after the first immunization with TRB-001. Participants will be evaluated at week 24. Assessments will include safety, immunogenicity, blood-/CS
PROSENEX Study Centre at the ATOMOS Klinik Währing
Vienna, Austria
RECRUITINGIncidence of local and systemic treatment-emergent adverse events (TEAEs)
Incidence of local and systemic treatment-emergent adverse events (TEAEs) (occurrence, intensity, duration, and relationship to IMP) over 6-months
Time frame: 6 months
Titers of vaccine-induced antibodies in blood and CSF
Titers of vaccine-induced antibodies (immunizing peptide, aSyn monomer; area under the curve for both parameters) in blood and CSF (peptide only) over 6 months compared to baseline
Time frame: 6 months
Change from baseline in total aSyn levels
Change from baseline in total aSyn levels as assessed by ELISA in blood and CSF
Time frame: 6 months
Change in levels of aggregated aSyn in blood and CSF
Change from baseline in levels of aggregated aSyn in blood and CSF
Time frame: 6 months
Change in GFAP and Neurofilament light chain in CSF
Change from baseline in GFAP and Neurofilament light chain in CSF
Time frame: 6 months
Avidity of antibodies induced for aggregated aSyn
Avidity of antibodies induced for aggregated aSyn as assessed after the vaccination with TRB-001 compared to baseline
Time frame: 6 months
Selectivity of antibodies induced by TRB-001
Selectivity of antibodies induced by TRB-001 for aggregated aSyn
Time frame: 6 months
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Change from baseline of the seed amplification assay signal (CSF)
Change from baseline of the seed amplification assay signal (CSF)
Time frame: 6 months
Correlation between measures of the antibody response
Correlation between measures of the antibody response (peptide titer, aSyn titer, avidity, titers x avidity, selectivity and biomarkers of the disease) (change from baseline in total aSyn levels, levels of aggregated aSyn in blood and CSF)
Time frame: 6 months
Change in MDS-UPDRS I, II, III, and IV
Change from baseline in MDS-UPDRS I, II, III, IV
Time frame: 6 months
Change from baseline in PD symptoms
Change from baseline in PD symptoms using the wearable device STAT-ON(TM)
Time frame: 6 months
Change in symptomatic PD medication
Change from baseline in symptomatic PD medication (Levodopa equivalent dose)
Time frame: 6 months
Change in levels of circulating extracellular vesicle (EV)-based biomarkers
Change from baseline in Levels of circulating extracellular vesicle (EV)-based biomarkers
Time frame: 6 months
Change in the number of vaccine specific B- and T cell clones
Change from baseline in the number of vaccine specific B- and T cell clones as assessed by B/T cell receptor sequencing
Time frame: 6 months
Incidence of local and systemic TEAEs
Incidence of local and systemic TEAEs over 12- months
Time frame: 12 months
Change from baseline in total aSyn levels
Change from baseline in total aSyn levels as assessed by ELISA in blood
Time frame: 12 months
Change from baseline in levels of aggregated aSyn in blood
Change from baseline in levels of aggregated aSyn in blood
Time frame: 12 months
Titers of vaccine-induced antibodies in blood
Titers of vaccine-induced antibodies (immunizing peptide, aSyn monomer; area under the curve for both parameters) in blood
Time frame: 12 months
Change from baseline in MDS-UPDRS I, II, III, IV at 12 month time period
Change from baseline in MDS-UPDRS I, II, III, IV
Time frame: 12 months
Change from baseline in PD symptoms at 12 month time period
Change from baseline in PD symptoms using the wearable device STAT-ONTM
Time frame: 12 months
Change from baseline in symptomatic PD medication at 12 month time period
Change from baseline in symptomatic PD medication (Levodopa equivalent dose) Change from baseline in the number of vaccine specific B- and T cell clones as assessed by B/T cell receptor sequencing
Time frame: 12 months