Overview

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

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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
• 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
• History of drug or alcohol abuse within the past 5 years
• Recent history (≤2 years) of cancer (exceptions; basal cell carcinoma, intraepithelial cervical neoplasia)
• Birthmarks, tattoos, wounds, or skin conditions that may obscure the assessment of injection site reactions
• 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
• 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