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

NCT07777484 | Recruiting Phase 1

• 2 other identifiers: TRB-Boost-0012026-526294-42-00
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of local and systemic treatment-emergent adverse events (TEAEs)

  Incidence of local and systemic treatment-emergent adverse events (TEAEs) (occurrence, intensity, duration, and relationship to IMP) over 6-months

  6 months

Secondary Outcomes (20)

• Titers of vaccine-induced antibodies in blood and CSF

  6 months

• Change from baseline in total aSyn levels

  6 months

• Change in levels of aggregated aSyn in blood and CSF

  6 months

• Change in GFAP and Neurofilament light chain in CSF

  6 months

• Avidity of antibodies induced for aggregated aSyn

  6 months

Study Arms (1)

Verum Arm

EXPERIMENTAL

Each participant will receive 1 immunization with Vaccine at week 0. Participants may also receive a 2nd immunization at week 4-6, pending safety and immunogenicity results and decision from PI, Sponsor, and Medical Monitor.

Biological: TRB-001

Interventions

TRB-001 BIOLOGICAL

This is 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. After the screening period, all participants who are enrolled in the study will receive a first intradermal TRB-001 immunization at a dose of 100μg. Patients antibody response will be assessed at week two (compared to baseline). Based on the safety and immunogenicity results, the PI, Medical Monitor, and Sponsor will decide on a potential second immunization with TRB-001. Regarding immunogenicity, a predefined cut-off will be used. The patient may be offered another injection to be applied 4-6 weeks after the first immunization with TRB-001. Participants will be evaluated at week 24. Assessments will include safety, immunogenicity, blood-/CS

Verum Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tridem Bioscience FlexCo: lead

Study Sites (1)

PROSENEX Study Centre at the ATOMOS Klinik Währing

Vienna, 1180, Austria

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Achim Schneeberger, Dr.

  Tridem Bioscience FlexCo

  STUDY DIRECTOR

Central Study Contacts

Markus Mandler

CONTACT

+43 699 11603817; markus.mandler@tridem.at

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

AU (1)