An Unblinded, Single Arm, Pilot Observational Study to Test the Safety, Tolerability, Immunogenicity and the Biological Effects of TRB-001 Vaccination.
7 de setembro de 2026 atualizado 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
Visão geral do estudo
Tipo de estudo
Intervencional
Inscrição (Estimado)
6
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Markus Mandler
- Número de telefone: +43 699 11603817
- E-mail: markus.mandler@tridem.at
Locais de estudo
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Vienna, Áustria, 1180
- Recrutamento
- PROSENEX Study Centre at the ATOMOS Klinik Währing
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Contato:
- Dieter Volc, Dr.
- Número de telefone: +43 (0)1 261660
- E-mail: dieter@volc.at
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Incidence of local and systemic treatment-emergent adverse events (TEAEs)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Titers of vaccine-induced antibodies in blood and CSF
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Achim Schneeberger, Dr., Tridem Bioscience FlexCo
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
28 de julho de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2026
Conclusão do estudo (Estimado)
1 de julho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
17 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de agosto de 2026
Primeira postagem (Real)
20 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TRB-Boost-001
- 2026-526294-42-00 (Ctis)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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