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Parkinson's DiseasePhase 1NCT07777484

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

A Phase 1 study testing TRB-001 in people with Parkinson's Disease, run by Tridem Bioscience FlexCo at 1 site in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson's Disease
What is being tested?
TRB-001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteAustria
Study dates
28 Jul 2026to Jul 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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))
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Markus Mandler contact

+43 699 11603817

markus.mandler@tridem.at

Austria1 site, 1 recruiting

  • PROSENEX Study Centre at the ATOMOS Klinik Währing

    Vienna, 1180

    Dieter Volc, Dr., +43 (0)1 261660, dieter@volc.at

    Recruiting

Other trials in Austria

About this study

Official 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

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

Being tested
TRB-001
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRB-001Biological

    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

Study groups in NCT07777484
Study groupRoleWhat they receive
Verum ArmExperimentalEach 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.
Receives: Biological: TRB-001

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (20)

  1. Titers of vaccine-induced antibodies in blood and CSF

    Titers of vaccine-induced antibodies (immunizing peptide, aSyn monomer; area under the curve for both parameters) in blood and CSF (peptide only) over 6 months compared to baseline

    Measured: 6 months

  2. Change from baseline in total aSyn levels

    Change from baseline in total aSyn levels as assessed by ELISA in blood and CSF

    Measured: 6 months

  3. Change in levels of aggregated aSyn in blood and CSF

    Change from baseline in levels of aggregated aSyn in blood and CSF

    Measured: 6 months

  4. Change in GFAP and Neurofilament light chain in CSF

    Change from baseline in GFAP and Neurofilament light chain in CSF

    Measured: 6 months

  5. Avidity of antibodies induced for aggregated aSyn

    Avidity of antibodies induced for aggregated aSyn as assessed after the vaccination with TRB-001 compared to baseline

    Measured: 6 months

  6. Selectivity of antibodies induced by TRB-001

    Selectivity of antibodies induced by TRB-001 for aggregated aSyn

    Measured: 6 months

  7. Change from baseline of the seed amplification assay signal (CSF)

    Change from baseline of the seed amplification assay signal (CSF)

    Measured: 6 months

  8. Correlation between measures of the antibody response

    Correlation between measures of the antibody response (peptide titer, aSyn titer, avidity, titers x avidity, selectivity and biomarkers of the disease) (change from baseline in total aSyn levels, levels of aggregated aSyn in blood and CSF)

    Measured: 6 months

  9. Change in MDS-UPDRS I, II, III, and IV

    Change from baseline in MDS-UPDRS I, II, III, IV

    Measured: 6 months

  10. Change from baseline in PD symptoms

    Change from baseline in PD symptoms using the wearable device STAT-ON(TM)

    Measured: 6 months

  11. Change in symptomatic PD medication

    Change from baseline in symptomatic PD medication (Levodopa equivalent dose)

    Measured: 6 months

  12. Change in levels of circulating extracellular vesicle (EV)-based biomarkers

    Change from baseline in Levels of circulating extracellular vesicle (EV)-based biomarkers

    Measured: 6 months

  13. Change in the number of vaccine specific B- and T cell clones

    Change from baseline in the number of vaccine specific B- and T cell clones as assessed by B/T cell receptor sequencing

    Measured: 6 months

  14. Incidence of local and systemic TEAEs

    Incidence of local and systemic TEAEs over 12- months

    Measured: 12 months

  15. Change from baseline in total aSyn levels

    Change from baseline in total aSyn levels as assessed by ELISA in blood

    Measured: 12 months

  16. Change from baseline in levels of aggregated aSyn in blood

    Change from baseline in levels of aggregated aSyn in blood

    Measured: 12 months

  17. Titers of vaccine-induced antibodies in blood

    Titers of vaccine-induced antibodies (immunizing peptide, aSyn monomer; area under the curve for both parameters) in blood

    Measured: 12 months

  18. Change from baseline in MDS-UPDRS I, II, III, IV at 12 month time period

    Change from baseline in MDS-UPDRS I, II, III, IV

    Measured: 12 months

  19. Change from baseline in PD symptoms at 12 month time period

    Change from baseline in PD symptoms using the wearable device STAT-ONTM

    Measured: 12 months

  20. Change from baseline in symptomatic PD medication at 12 month time period

    Change from baseline in symptomatic PD medication (Levodopa equivalent dose) Change from baseline in the number of vaccine specific B- and T cell clones as assessed by B/T cell receptor sequencing

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2026
  2. Study start28 Jul 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07777484
Sponsor's protocol ID
TRB-Boost-001
Other IDs
2026-526294-42-00
Status last verified
Sep 2026
First submitted
17 Aug 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TRB-001 in people with Parkinson's Disease, run by Tridem Bioscience FlexCo at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Markus Mandler (+43 699 11603817, markus.mandler@tridem.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of local and systemic treatment-emergent adverse events (TEAEs) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07777484.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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