TRB-001 Vaccine in People With Parkinson's Disease Who Had Earlier Immunotherapy
Tests the TRB-001 vaccine in adults with Parkinson's disease treated before.
Plain-language title generated from the registry record
Registry title: An Unblinded, Single Arm, Pilot Observational Study to Test the Safety, Tolerability, Immunogenicity and the Biological Effects of TRB-001 Vaccination.
Key facts
- Where
- Vienna, AustriaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Has a doctor told you that you have a different condition with similar signs, such as multiple system atrophy or progressive supranuclear palsy?
- Do you have dementia, or serious problems with memory and thinking?
- Are you pregnant, breastfeeding, or planning a pregnancy?
- Do you have an ongoing infection with hepatitis B, hepatitis C or HIV?
Source: NCT07777484, who can take part
Where in Austria
- Prosenex Ambulatorium BetriebsgmbHVienna, AustriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tridem Bioscience FlexCo
- Trial code
- NCT07777484EU 2026-526294-42-00
- Record updated
- 10 September 2026
- Original description
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 immunotherapyRead full original descriptionShow less
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
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
Inclusion: 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: 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.