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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 in Individuals Who Have Previously Undergone aSyn Immunotherapy

NCT07777484 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-08-20

No results posted yet for this study

Summary

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

Conditions

Interventions

BIOLOGICAL

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

Sponsors & Collaborators

  • Tridem Bioscience FlexCo

    lead INDUSTRY

Principal Investigators

  • Achim Schneeberger, Dr. · Tridem Bioscience FlexCo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-28
Primary Completion
2026-12-31
Completion
2027-07-31

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07777484 on ClinicalTrials.gov