An Unblinded, Single Arm, Pilot Observational Study to Test the Safety, Tolerability, Immunogenicity and the Biological Effects of TRB-001 Vaccination.

Ki vehet részt

• 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

Ki nem vehet részt

• Any relevant systemic illness. This includes cardiovascular, hepatic, gastroenterological, respiratory, endocrinological, hematologic disease, or any other condition that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study, unless patient has been on stable doses of medication for any of these concurrent illnesses for at least 3 months prior to study entry
• Unstable psychiatric illness, including psychosis, suicidal ideation, untreated major depression, schizophrenia, or bipolar affective disorder within 90 days before Visit 1, as determined by the investigator
• Participation in the active treatment phase of any non-PD clinical trial within 30 days prior to Visit 1
• Dose limiting toxicity to previous immunization with aSyn-based PD vaccine
• Current immunosuppressive therapy
• Known or suspected allergy, or history of anaphylaxis, to vaccines or their excipients, if considered relevant by the investigator
• Presence or history of autoimmune disease or immunodeficiency, if considered relevant by the investigator
• Presence of active infectious disease (hepatitis B, hepatitis C, or human immunodeficiency virus (HIV))
• Significant cognitive impairment or clinical dementia, or a Montreal Cognitive Assessment (MoCA) score <26
• High suspicion of other parkinsonian syndromes, such as multiple system atrophy, progressive supranuclear palsy, drug-induced Parkinsonism and post-encephalitic Parkinsonism
• History of drug or alcohol abuse within the past 5 years
• Birthmarks, tattoos, wounds, or skin conditions that may obscure the assessment of injection site reactions
• Recent history (≤2 years) of cancer (exceptions; basal cell carcinoma, intraepithelial cervical neoplasia)
• Women of childbearing potential without use of contraception
• Women who are pregnant or lactating
• Contraindication for MRI or lumbar puncture
• Employee at the study site, spouse/partner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse) or relationship to sponsor