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
At least 18-years of age
Female or male with previous treatment with active aSyn immunotherapy
Parkinson's disease diagnosis (any stage)
Understands and agrees to comply with the study procedures and provides written informed consent
Women of childbearing potential without use of contraception
Women who are pregnant or lactating
Contraindication for MRI or lumbar puncture
Known or suspected allergy, or history of anaphylaxis, to vaccines or their excipients, if considered relevant by the investigator
Single group
TRB-001
Biological/VaccineThis 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
Incidence 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
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
Change from baseline in total aSyn levels
Change from baseline in total aSyn levels as assessed by ELISA in blood and CSF
Change in levels of aggregated aSyn in blood and CSF
Change from baseline in levels of aggregated aSyn in blood and CSF
Change in GFAP and Neurofilament light chain in CSF
Change from baseline in GFAP and Neurofilament light chain in CSF
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