[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652575":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":50,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":20,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Tridem Bioscience FlexCo","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Verum Arm","EXPERIMENTAL","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.",[13],"Biological: TRB-001",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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-\u002FCS",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Achim Schneeberger, Dr.","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Markus Mandler","CONTACT","+43 699 11603817","markus.mandler@tridem.at",[32],{"facility":33,"status":34,"city":35,"state":20,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"PROSENEX Study Centre at the ATOMOS Klinik Währing","RECRUITING","Vienna","1180","Austria","AT",{"type":40,"coordinates":41},"Point",[42,43],16.37208,48.20849,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":48,"phoneExt":20,"email":49},"Dieter Volc, Dr.","+43 (0)1 261660","dieter@volc.at",{"type":51,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100652575","phase-1-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-100652575",false,"NCT07777484","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","Inclusion Criteria:\n\n* At least 18-years of age\n* Female or male with previous treatment with active aSyn immunotherapy\n* Parkinson's disease diagnosis (any stage)\n* Understands and agrees to comply with the study procedures and provides written informed consent\n\nExclusion Criteria:\n\n* Women of childbearing potential without use of contraception\n* Women who are pregnant or lactating\n* Contraindication for MRI or lumbar puncture\n* Known or suspected allergy, or history of anaphylaxis, to vaccines or their excipients, if considered relevant by the investigator\n* Presence or history of autoimmune disease or immunodeficiency, if considered relevant by the investigator\n* Presence of active infectious disease (hepatitis B, hepatitis C, or human immunodeficiency virus (HIV))\n* Significant cognitive impairment or clinical dementia, or a Montreal Cognitive Assessment (MoCA) score \\\u003C26\n* High suspicion of other parkinsonian syndromes, such as multiple system atrophy, progressive supranuclear palsy, drug-induced Parkinsonism and post-encephalitic Parkinsonism\n* 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\n* 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\n* History of drug or alcohol abuse within the past 5 years\n* Recent history (≤2 years) of cancer (exceptions; basal cell carcinoma, intraepithelial cervical neoplasia)\n* Birthmarks, tattoos, wounds, or skin conditions that may obscure the assessment of injection site reactions\n* Participation in the active treatment phase of any non-PD clinical trial within 30 days prior to Visit 1\n* Dose limiting toxicity to previous immunization with aSyn-based PD vaccine\n* Current immunosuppressive therapy\n* Employee at the study site, spouse\u002Fpartner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse) or relationship to sponsor","ALL","18 Years",{"count":61,"type":62},6,"ESTIMATED","INTERVENTIONAL",[65],"PHASE1","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",[68],"Parkinson's Disease","2026-08-17",{"date":71,"type":72},"2026-08-20","ACTUAL",{"date":74,"type":72},"2026-07-28",{"date":76,"type":62},"2027-07",{"name":5,"class":6},1]