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

2026年9月7日更新者：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

研究概览

地位

招聘中

条件

帕金森病

干预/治疗

生物：TRB-001

研究类型

介入性

注册 (估计的)

阶段

阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Markus Mandler
电话号码：+43 699 11603817
邮箱：markus.mandler@tridem.at

学习地点

奥地利
- - Vienna、奥地利、1180
    - 招聘中
    - PROSENEX Study Centre at the ATOMOS Klinik Währing
    - 接触：
      
      Dieter Volc, Dr.
      
      电话号码：+43 (0)1 261660
      
      邮箱：dieter@volc.at

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：不适用
介入模型：单组作业
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：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.	生物：TRB-001 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

参与者组/臂

干预/治疗

实验性的：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.

生物：TRB-001

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

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Incidence of local and systemic treatment-emergent adverse events (TEAEs) 大体时间：6 months	Incidence of local and systemic treatment-emergent adverse events (TEAEs) (occurrence, intensity, duration, and relationship to IMP) over 6-months	6 months

次要结果测量

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Tridem Bioscience FlexCo

调查人员

研究主任：Achim Schneeberger, Dr.、Tridem Bioscience FlexCo

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月28日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2027年7月1日

研究注册日期

首次提交

2026年8月17日

首先提交符合 QC 标准的

2026年8月17日

首次发布 (实际的)

2026年8月20日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月7日

最后验证

2026年9月1日

结果测量	措施说明	大体时间
Titers of vaccine-induced antibodies in blood and CSF 大体时间：6 months	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	6 months
Change from baseline in total aSyn levels 大体时间：6 months	Change from baseline in total aSyn levels as assessed by ELISA in blood and CSF	6 months
Change in levels of aggregated aSyn in blood and CSF 大体时间：6 months	Change from baseline in levels of aggregated aSyn in blood and CSF	6 months
Change in GFAP and Neurofilament light chain in CSF 大体时间：6 months	Change from baseline in GFAP and Neurofilament light chain in CSF	6 months
Avidity of antibodies induced for aggregated aSyn 大体时间：6 months	Avidity of antibodies induced for aggregated aSyn as assessed after the vaccination with TRB-001 compared to baseline	6 months
Selectivity of antibodies induced by TRB-001 大体时间：6 months	Selectivity of antibodies induced by TRB-001 for aggregated aSyn	6 months
Change from baseline of the seed amplification assay signal (CSF) 大体时间：6 months	Change from baseline of the seed amplification assay signal (CSF)	6 months
Correlation between measures of the antibody response 大体时间：6 months	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)	6 months
Change in MDS-UPDRS I, II, III, and IV 大体时间：6 months	Change from baseline in MDS-UPDRS I, II, III, IV	6 months
Change from baseline in PD symptoms 大体时间：6 months	Change from baseline in PD symptoms using the wearable device STAT-ON(TM)	6 months
Change in symptomatic PD medication 大体时间：6 months	Change from baseline in symptomatic PD medication (Levodopa equivalent dose)	6 months
Change in levels of circulating extracellular vesicle (EV)-based biomarkers 大体时间：6 months	Change from baseline in Levels of circulating extracellular vesicle (EV)-based biomarkers	6 months
Change in the number of vaccine specific B- and T cell clones 大体时间：6 months	Change from baseline in the number of vaccine specific B- and T cell clones as assessed by B/T cell receptor sequencing	6 months
Incidence of local and systemic TEAEs 大体时间：12 months	Incidence of local and systemic TEAEs over 12- months	12 months
Change from baseline in total aSyn levels 大体时间：12 months	Change from baseline in total aSyn levels as assessed by ELISA in blood	12 months
Change from baseline in levels of aggregated aSyn in blood 大体时间：12 months	Change from baseline in levels of aggregated aSyn in blood	12 months
Titers of vaccine-induced antibodies in blood 大体时间：12 months	Titers of vaccine-induced antibodies (immunizing peptide, aSyn monomer; area under the curve for both parameters) in blood	12 months
Change from baseline in MDS-UPDRS I, II, III, IV at 12 month time period 大体时间：12 months	Change from baseline in MDS-UPDRS I, II, III, IV	12 months
Change from baseline in PD symptoms at 12 month time period 大体时间：12 months	Change from baseline in PD symptoms using the wearable device STAT-ONTM	12 months
Change from baseline in symptomatic PD medication at 12 month time period 大体时间：12 months	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	12 months

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