An Unblinded, Single Arm, Pilot Observational Study to Test the Safety, Tolerability, Immunogenicity and the Biological Effects of TRB-001 Vaccination.
7 settembre 2026 aggiornato da: Tridem Bioscience FlexCo
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
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Stimato)
6
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Markus Mandler
- Numero di telefono: +43 699 11603817
- Email: markus.mandler@tridem.at
Luoghi di studio
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Vienna, Austria, 1180
- Reclutamento
- PROSENEX Study Centre at the ATOMOS Klinik Währing
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Contatto:
- Dieter Volc, Dr.
- Numero di telefono: +43 (0)1 261660
- Email: dieter@volc.at
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Verum Arm
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.
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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
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Incidence of local and systemic treatment-emergent adverse events (TEAEs)
Lasso di tempo: 6 months
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Incidence of local and systemic treatment-emergent adverse events (TEAEs) (occurrence, intensity, duration, and relationship to IMP) over 6-months
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6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Titers of vaccine-induced antibodies in blood and CSF
Lasso di tempo: 6 months
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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
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6 months
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Change from baseline in total aSyn levels
Lasso di tempo: 6 months
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Change from baseline in total aSyn levels as assessed by ELISA in blood and CSF
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6 months
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Change in levels of aggregated aSyn in blood and CSF
Lasso di tempo: 6 months
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Change from baseline in levels of aggregated aSyn in blood and CSF
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6 months
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Change in GFAP and Neurofilament light chain in CSF
Lasso di tempo: 6 months
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Change from baseline in GFAP and Neurofilament light chain in CSF
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6 months
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Avidity of antibodies induced for aggregated aSyn
Lasso di tempo: 6 months
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Avidity of antibodies induced for aggregated aSyn as assessed after the vaccination with TRB-001 compared to baseline
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6 months
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Selectivity of antibodies induced by TRB-001
Lasso di tempo: 6 months
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Selectivity of antibodies induced by TRB-001 for aggregated aSyn
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6 months
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Change from baseline of the seed amplification assay signal (CSF)
Lasso di tempo: 6 months
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Change from baseline of the seed amplification assay signal (CSF)
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6 months
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Correlation between measures of the antibody response
Lasso di tempo: 6 months
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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)
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6 months
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Change in MDS-UPDRS I, II, III, and IV
Lasso di tempo: 6 months
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Change from baseline in MDS-UPDRS I, II, III, IV
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6 months
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Change from baseline in PD symptoms
Lasso di tempo: 6 months
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Change from baseline in PD symptoms using the wearable device STAT-ON(TM)
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6 months
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Change in symptomatic PD medication
Lasso di tempo: 6 months
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Change from baseline in symptomatic PD medication (Levodopa equivalent dose)
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6 months
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Change in levels of circulating extracellular vesicle (EV)-based biomarkers
Lasso di tempo: 6 months
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Change from baseline in Levels of circulating extracellular vesicle (EV)-based biomarkers
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6 months
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Change in the number of vaccine specific B- and T cell clones
Lasso di tempo: 6 months
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Change from baseline in the number of vaccine specific B- and T cell clones as assessed by B/T cell receptor sequencing
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6 months
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Incidence of local and systemic TEAEs
Lasso di tempo: 12 months
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Incidence of local and systemic TEAEs over 12- months
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12 months
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Change from baseline in total aSyn levels
Lasso di tempo: 12 months
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Change from baseline in total aSyn levels as assessed by ELISA in blood
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12 months
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Change from baseline in levels of aggregated aSyn in blood
Lasso di tempo: 12 months
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Change from baseline in levels of aggregated aSyn in blood
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12 months
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Titers of vaccine-induced antibodies in blood
Lasso di tempo: 12 months
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Titers of vaccine-induced antibodies (immunizing peptide, aSyn monomer; area under the curve for both parameters) in blood
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12 months
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Change from baseline in MDS-UPDRS I, II, III, IV at 12 month time period
Lasso di tempo: 12 months
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Change from baseline in MDS-UPDRS I, II, III, IV
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12 months
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Change from baseline in PD symptoms at 12 month time period
Lasso di tempo: 12 months
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Change from baseline in PD symptoms using the wearable device STAT-ONTM
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12 months
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Change from baseline in symptomatic PD medication at 12 month time period
Lasso di tempo: 12 months
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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
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12 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Achim Schneeberger, Dr., Tridem Bioscience FlexCo
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
28 luglio 2026
Completamento primario (Stimato)
1 dicembre 2026
Completamento dello studio (Stimato)
1 luglio 2027
Date di iscrizione allo studio
Primo inviato
17 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
17 agosto 2026
Primo Inserito (Effettivo)
20 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TRB-Boost-001
- 2026-526294-42-00 (Ctis)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .