An Unblinded, Single Arm, Pilot Observational Study to Test the Safety, Tolerability, Immunogenicity and the Biological Effects of TRB-001 Vaccination.
7 de septiembre de 2026 actualizado por: 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
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
6
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Markus Mandler
- Número de teléfono: +43 699 11603817
- Correo electrónico: markus.mandler@tridem.at
Ubicaciones de estudio
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Vienna, Austria, 1180
- Reclutamiento
- PROSENEX Study Centre at the ATOMOS Klinik Währing
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Contacto:
- Dieter Volc, Dr.
- Número de teléfono: +43 (0)1 261660
- Correo electrónico: dieter@volc.at
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of local and systemic treatment-emergent adverse events (TEAEs)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Titers of vaccine-induced antibodies in blood and CSF
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Achim Schneeberger, Dr., Tridem Bioscience FlexCo
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
28 de julio de 2026
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de julio de 2027
Fechas de registro del estudio
Enviado por primera vez
17 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de agosto de 2026
Publicado por primera vez (Actual)
20 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TRB-Boost-001
- 2026-526294-42-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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