An Unblinded, Single Arm, Pilot Observational Study to Test the Safety, Tolerability, Immunogenicity and the Biological Effects of TRB-001 Vaccination.
7 septembre 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
6
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Markus Mandler
- Numéro de téléphone: +43 699 11603817
- E-mail: markus.mandler@tridem.at
Lieux d'étude
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Vienna, L'Autriche, 1180
- Recrutement
- PROSENEX Study Centre at the ATOMOS Klinik Währing
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Contact:
- Dieter Volc, Dr.
- Numéro de téléphone: +43 (0)1 261660
- E-mail: dieter@volc.at
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Incidence of local and systemic treatment-emergent adverse events (TEAEs)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Titers of vaccine-induced antibodies in blood and CSF
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Achim Schneeberger, Dr., Tridem Bioscience FlexCo
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
28 juillet 2026
Achèvement primaire (Estimé)
1 décembre 2026
Achèvement de l'étude (Estimé)
1 juillet 2027
Dates d'inscription aux études
Première soumission
17 août 2026
Première soumission répondant aux critères de contrôle qualité
17 août 2026
Première publication (Réel)
20 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TRB-Boost-001
- 2026-526294-42-00 (Ctis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .