An Unblinded, Single Arm, Pilot Observational Study to Test the Safety, Tolerability, Immunogenicity and the Biological Effects of TRB-001 Vaccination.
7 september 2026 uppdaterad av: 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
Studieöversikt
Studietyp
Interventionell
Inskrivning (Beräknad)
6
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Markus Mandler
- Telefonnummer: +43 699 11603817
- E-post: markus.mandler@tridem.at
Studieorter
-
-
-
Vienna, Österrike, 1180
- Rekrytering
- PROSENEX Study Centre at the ATOMOS Klinik Währing
-
Kontakt:
- Dieter Volc, Dr.
- Telefonnummer: +43 (0)1 261660
- E-post: dieter@volc.at
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of local and systemic treatment-emergent adverse events (TEAEs)
Tidsram: 6 months
|
Incidence of local and systemic treatment-emergent adverse events (TEAEs) (occurrence, intensity, duration, and relationship to IMP) over 6-months
|
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Titers of vaccine-induced antibodies in blood and CSF
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 6 months
|
Change from baseline in GFAP and Neurofilament light chain in CSF
|
6 months
|
|
Avidity of antibodies induced for aggregated aSyn
Tidsram: 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
Tidsram: 6 months
|
Selectivity of antibodies induced by TRB-001 for aggregated aSyn
|
6 months
|
|
Change from baseline of the seed amplification assay signal (CSF)
Tidsram: 6 months
|
Change from baseline of the seed amplification assay signal (CSF)
|
6 months
|
|
Correlation between measures of the antibody response
Tidsram: 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
Tidsram: 6 months
|
Change from baseline in MDS-UPDRS I, II, III, IV
|
6 months
|
|
Change from baseline in PD symptoms
Tidsram: 6 months
|
Change from baseline in PD symptoms using the wearable device STAT-ON(TM)
|
6 months
|
|
Change in symptomatic PD medication
Tidsram: 6 months
|
Change from baseline in symptomatic PD medication (Levodopa equivalent dose)
|
6 months
|
|
Change in levels of circulating extracellular vesicle (EV)-based biomarkers
Tidsram: 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
Tidsram: 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
Tidsram: 12 months
|
Incidence of local and systemic TEAEs over 12- months
|
12 months
|
|
Change from baseline in total aSyn levels
Tidsram: 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
Tidsram: 12 months
|
Change from baseline in levels of aggregated aSyn in blood
|
12 months
|
|
Titers of vaccine-induced antibodies in blood
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Achim Schneeberger, Dr., Tridem Bioscience FlexCo
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
28 juli 2026
Primärt slutförande (Beräknad)
1 december 2026
Avslutad studie (Beräknad)
1 juli 2027
Studieregistreringsdatum
Först inskickad
17 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
17 augusti 2026
Första postat (Faktisk)
20 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TRB-Boost-001
- 2026-526294-42-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .