Recruiting · registry statusTesting a vaccine after earlier immune treatment
Researchers study the safety and immune effects of the TRB-001 vaccine in people who previously received treatment targeting a Parkinson’s-related protein.
Testing a treatment or activity · Study reference: NCT07777484
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
Open the official registry record ↗Who can join?
Age 18 years and over · Does not accept healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
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
Full study name & original research details
Official study title
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
Short title used by the registry
An Unblinded, Single Arm, Pilot Observational Study to Test the Safety, Tolerability, Immunogenicity and the Biological Effects of TRB-001 Vaccination.
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 immunotherapy
Conditions reported: Parkinson's Disease
- Study type
- Interventional
- Interventions
- TRB-001
- Phases
- PHASE1
- Sponsor
- Tridem Bioscience FlexCo
- Start date reported by registry
- 2026-07-28 (actual)
Registry updated: 2026-09-10 · Status last verified by the registry submitter: 2026-09
Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Markus Mandler · +43 699 11603817 · markus.mandler@tridem.at
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
PROSENEX Study Centre at the ATOMOS Klinik Währing
Vienna, Austria
RecruitingDieter Volc, Dr. · +43 (0)1 261660 · dieter@volc.at
The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.