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
調査の概要
研究の種類
介入
入学 (推定)
6
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Markus Mandler
- 電話番号：+43 699 11603817
- メール：markus.mandler@tridem.at
研究場所
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Vienna、オーストリア、1180
- 募集
- PROSENEX Study Centre at the ATOMOS Klinik Währing
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コンタクト：
- Dieter Volc, Dr.
- 電話番号：+43 (0)1 261660
- メール：dieter@volc.at
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of local and systemic treatment-emergent adverse events (TEAEs)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Titers of vaccine-induced antibodies in blood and CSF
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Achim Schneeberger, Dr.、Tridem Bioscience FlexCo
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年7月28日
一次修了 (推定)
2026年12月1日
研究の完了 (推定)
2027年7月1日
試験登録日
最初に提出
2026年8月17日
QC基準を満たした最初の提出物
2026年8月17日
最初の投稿 (実際)
2026年8月20日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月10日
QC基準を満たした最後の更新が送信されました
2026年9月7日
最終確認日
2026年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。