TRB-001 vaccination in Parkinson's disease: safety and biological effects in a small, single-arm study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an unblinded, single-arm, phase 1 pilot study designed to assess the safety and tolerability of the TRB-001 vaccine in people with Parkinson's disease who have prior exposure to active aSyn immunotherapy. The study will also evaluate immunogenicity and potential biological effects of the vaccine. Participants must be adults with PD and a history of aSyn immunotherapy, and will undergo procedures including MRI and possibly lumbar puncture, with informed consent required. The trial design does not include a control group and aims to generate early safety and mechanistic signals to inform future development.

Why it matters

Who can join: the full rules

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

Where it's running

• PROSENEX Study Centre at the ATOMOS Klinik Währing
  Vienna, Austria Recruiting

Study contacts

• Study coordinator: Markus Mandler
• Email: markus.mandler@tridem.at
• Phone: +43 699 11603817

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.