Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centre for Human Drug Research, Netherlands | OTHER |
| Worldwide Clinical Trials | OTHER |
| Vaxxinity, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is a 44-week, randomized, placebo-controlled, double-blind, single-center, phase 1 clinical trial consisting of a dose-escalation Part A study in healthy participants, followed by a Part B in participants with Parkinson's disease with a selected doses from Part A.
This is a first-in-human Phase 1 study to determine the safety, tolerability, and immunogenicity of UB-312 in healthy participants and in participants with Parkinson's disease (PD). UB-312 is a UBITh®-enhanced synthetic peptide-based vaccine and may provide an active immunotherapy option for treating synucleinopathies including the most prevalent form, PD.
The study consists of two parts. Part A of the study with healthy participants will consist of dose escalation and cohort staggering for up to seven planned dose levels or placebo. Part B of the study will consist of two cohorts of participants with Parkinson's disease (PD). Dosing for Part B will be based on safety, tolerability and immunogenicity from Part A. All eligible participants will be enrolled in a 44-week study consisting of 20 weeks of treatment and 24 weeks of follow-up.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: UB-312 40 mcg | Experimental | UB-312 40 mcg by intramuscular injection at Weeks 1, 5 and 13 |
|
| Part A: UB-312 100 mcg | Experimental | UB-312 100 mcg by intramuscular injection at Weeks 1, 5 and 13 |
|
| Part A: UB-312 40/300 mcg | Experimental | UB-312 40 mcg at Week 1 and 300 mcg at Weeks 5 and 13 by intramuscular injection |
|
| Part A: UB-312 300 mcg | Experimental | UB-312 300 mcg by intramuscular injection at Weeks 1, 5 and 13 |
|
| Part A: UB-312 40/1000 mcg | Experimental | UB-312 40 mcg at Week 1 and 1000 mcg at Weeks 5 and 13 by intramuscular injection |
|
| Part A: UB-312 1000 mcg | Experimental | UB-312 1000 mcg by intramuscular injection at Weeks 1, 5 and 13 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UB-312 | Biological | A synthetic peptide-based vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events | Number of AEs will be assessed | 44 weeks |
| Immunogenicity of UB-312 as Determined by Anti-aSyn Antibodies in Blood | Number of Participants with Anti-aSyn Antibodies in Blood from Weeks 1 through 45. | 44 weeks |
| Immunogenicity of UB-312 as Determined by Anti-aSyn Antibodies in CSF | Number of Participants with Anti-aSyn Antibodies in CSF from Weeks 1 through 45. | 44 weeks |
Not provided
Not provided
Inclusion Criteria:
For Part B only:
Exclusion Criteria:
For Part B only:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Vaxxinity, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Human Drug Research | Leiden | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15755569 | Background | Wang CY, Walfield AM. Site-specific peptide vaccines for immunotherapy and immunization against chronic diseases, cancer, infectious diseases, and for veterinary applications. Vaccine. 2005 Mar 18;23(17-18):2049-56. doi: 10.1016/j.vaccine.2005.01.007. | |
| 17287052 | Background | Wang CY, Finstad CL, Walfield AM, Sia C, Sokoll KK, Chang TY, Fang XD, Hung CH, Hutter-Paier B, Windisch M. Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease. Vaccine. 2007 Apr 20;25(16):3041-52. doi: 10.1016/j.vaccine.2007.01.031. Epub 2007 Jan 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part A: UB-312 40 mcg | UB-312 40 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine |
| FG001 | Part A: UB-312 100 mcg | UB-312 100 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine |
| FG002 | Part A: UB-312 40/300 mcg | UB-312 40 mcg at Week 1 and 300 mcg at Weeks 5 and 13 by intramuscular injection UB-312: A synthetic peptide-based vaccine |
| FG003 | Part A: UB-312 300 mcg | UB-312 300 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine |
| FG004 | Part A: UB-312 40/1000 mcg | UB-312 40 mcg at Week 1 and 1000 mcg at Weeks 5 and 13 by intramuscular injection UB-312: A synthetic peptide-based vaccine |
| FG005 | Part A: UB-312 1000 mcg | UB-312 1000 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine |
| FG006 | Part A: UB-312 2000 mcg | UB-312 2000 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine |
| FG007 | Part A: Placebo | Placebo by intramuscular injection at Weeks 1, 5 and 13 Placebo: Matching placebo |
| FG008 | Part B: UB-312 300/100 mcg | UB-312 300 mcg at Week 1 and 100 mcg at Weeks 5 and 13 by intramuscular injection UB-312: A synthetic peptide-based vaccine |
| FG009 | Part B: UB-312 300 mcg | UB-312 300 mcg at Weeks 1, 5 and 13 by intramuscular injection UB-312: A synthetic peptide-based vaccine |
| FG010 | Part B: Placebo | Placebo by intramuscular injection at Weeks 1, 5 and 13 Placebo: Matching placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A: UB-312 40 mcg | UB-312 40 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine |
| BG001 | Part A: UB-312 100 mcg | UB-312 100 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Adverse Events | Number of AEs will be assessed | Posted | Number | TEAEs | 44 weeks |
|
Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.
Definition does not differ.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: UB-312 40 mcg | UB-312 40 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital Acquired Pneumonia (HAP) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Disorders | Eye disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Director, Clinical Development | Vaxxinity, Inc. | 254-244-5739 | info@vaxxinity.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 14, 2022 | Feb 13, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2023 | Feb 13, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020734 | Parkinsonian Disorders |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Part A: UB-312 2000 mcg | Experimental | UB-312 2000 mcg by intramuscular injection at Weeks 1, 5 and 13 |
|
| Part A: Placebo | Placebo Comparator | Placebo by intramuscular injection at Weeks 1, 5 and 13 |
|
| Part B: UB-312 300/100 mcg | Experimental | UB-312 300 mcg at Week 1 and 100 mcg at Weeks 5 and 13 by intramuscular injection |
|
| Part B: UB-312 300 mcg | Experimental | UB-312 300 mcg at Weeks 1, 5 and 13 by intramuscular injection |
|
| Part B: Placebo | Placebo Comparator | Placebo by intramuscular injection at Weeks 1, 5 and 13 |
|
| Placebo | Biological | Matching placebo |
|
| 29067332 | Background | Wang CY, Wang PN, Chiu MJ, Finstad CL, Lin F, Lynn S, Tai YH, De Fang X, Zhao K, Hung CH, Tseng Y, Peng WJ, Wang J, Yu CC, Kuo BS, Frohna PA. UB-311, a novel UBITh(R) amyloid beta peptide vaccine for mild Alzheimer's disease. Alzheimers Dement (N Y). 2017 Apr 14;3(2):262-272. doi: 10.1016/j.trci.2017.03.005. eCollection 2017 Jun. |
| 38902546 | Result | Eijsvogel P, Misra P, Concha-Marambio L, Boyd JD, Ding S, Fedor L, Hsieh YT, Sun YS, Vroom MM, Farris CM, Ma Y, de Kam ML, Radanovic I, Vissers MFJM, Mirski D, Shareghi G, Shahnawaz M, Singer W, Kremer P, Groeneveld GJ, Yu HJ, Dodart JC. Target engagement and immunogenicity of an active immunotherapeutic targeting pathological alpha-synuclein: a phase 1 placebo-controlled trial. Nat Med. 2024 Sep;30(9):2631-2640. doi: 10.1038/s41591-024-03101-8. Epub 2024 Jun 20. |
| 35426173 | Result | Yu HJ, Thijssen E, van Brummelen E, van der Plas JL, Radanovic I, Moerland M, Hsieh E, Groeneveld GJ, Dodart JC. A Randomized First-in-Human Study With UB-312, a UBITh(R) alpha-Synuclein Peptide Vaccine. Mov Disord. 2022 Jul;37(7):1416-1424. doi: 10.1002/mds.29016. Epub 2022 Apr 15. |
| BG002 | Part A: UB-312 40/300 mcg | UB-312 40 mcg at Week 1 and 300 mcg at Weeks 5 and 13 by intramuscular injection UB-312: A synthetic peptide-based vaccine |
| BG003 | Part A: UB-312 300 mcg | UB-312 300 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine |
| BG004 | Part A: UB-312 40/1000 mcg | UB-312 40 mcg at Week 1 and 1000 mcg at Weeks 5 and 13 by intramuscular injection UB-312: A synthetic peptide-based vaccine |
| BG005 | Part A: UB-312 1000 mcg | UB-312 1000 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine |
| BG006 | Part A: UB-312 2000 mcg | UB-312 2000 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine |
| BG007 | Part A: Placebo | Placebo by intramuscular injection at Weeks 1, 5 and 13 Placebo: Matching placebo |
| BG008 | Part B: UB-312 300/100 mcg | UB-312 300 mcg at Week 1 and 100 mcg at Weeks 5 and 13 by intramuscular injection UB-312: A synthetic peptide-based vaccine |
| BG009 | Part B: UB-312 300 mcg | UB-312 300 mcg at Weeks 1, 5 and 13 by intramuscular injection UB-312: A synthetic peptide-based vaccine |
| BG010 | Part B: Placebo | Placebo by intramuscular injection at Weeks 1, 5 and 13 Placebo: Matching placebo |
| BG011 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Part A: UB-312 300 mcg | UB-312 300 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine |
| OG004 | Part A: UB-312 40/1000 mcg | UB-312 40 mcg at Week 1 and 1000 mcg at Weeks 5 and 13 by intramuscular injection UB-312: A synthetic peptide-based vaccine |
| OG005 | Part A: UB-312 1000 mcg | UB-312 1000 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine |
| OG006 | Part A: UB-312 2000 mcg | UB-312 2000 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine |
| OG007 | Part A: Placebo | Placebo by intramuscular injection at Weeks 1, 5 and 13 Placebo: Matching placebo |
| OG008 | Part B: UB-312 300/100 mcg | UB-312 300 mcg at Week 1 and 100 mcg at Weeks 5 and 13 by intramuscular injection UB-312: A synthetic peptide-based vaccine |
| OG009 | Part B: UB-312 300 mcg | UB-312 300 mcg at Weeks 1, 5 and 13 by intramuscular injection UB-312: A synthetic peptide-based vaccine |
| OG010 | Part B: Placebo | Placebo by intramuscular injection at Weeks 1, 5 and 13 Placebo: Matching placebo |
|
|
| Primary | Immunogenicity of UB-312 as Determined by Anti-aSyn Antibodies in Blood | Number of Participants with Anti-aSyn Antibodies in Blood from Weeks 1 through 45. | Per protocol population | Posted | Count of Participants | Participants | 44 weeks |
|
|
|
| Primary | Immunogenicity of UB-312 as Determined by Anti-aSyn Antibodies in CSF | Number of Participants with Anti-aSyn Antibodies in CSF from Weeks 1 through 45. | per protocol population | Posted | Count of Participants | Participants | 44 weeks |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | Part A: UB-312 100 mcg | UB-312 100 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine | 0 | 6 | 0 | 6 | 6 | 6 |
| EG002 | Part A: UB-312 40/300 mcg | UB-312 40 mcg at Week 1 and 300 mcg at Weeks 5 and 13 by intramuscular injection UB-312: A synthetic peptide-based vaccine | 0 | 6 | 0 | 6 | 5 | 6 |
| EG003 | Part A: UB-312 300 mcg | UB-312 300 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine | 0 | 6 | 0 | 6 | 6 | 6 |
| EG004 | Part A: UB-312 40/1000 mcg | UB-312 40 mcg at Week 1 and 1000 mcg at Weeks 5 and 13 by intramuscular injection UB-312: A synthetic peptide-based vaccine | 0 | 6 | 0 | 6 | 6 | 6 |
| EG005 | Part A: UB-312 1000 mcg | UB-312 1000 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine | 0 | 6 | 0 | 6 | 6 | 6 |
| EG006 | Part A: UB-312 2000 mcg | UB-312 2000 mcg by intramuscular injection at Weeks 1, 5 and 13 UB-312: A synthetic peptide-based vaccine | 0 | 6 | 0 | 6 | 5 | 6 |
| EG007 | Part A: Placebo | Placebo by intramuscular injection at Weeks 1, 5 and 13 Placebo: Matching placebo | 0 | 8 | 0 | 8 | 8 | 8 |
| EG008 | Part B: UB-312 300/100 mcg | UB-312 300 mcg at Week 1 and 100 mcg at Weeks 5 and 13 by intramuscular injection UB-312: A synthetic peptide-based vaccine | 0 | 7 | 3 | 7 | 7 | 7 |
| EG009 | Part B: UB-312 300 mcg | UB-312 300 mcg at Weeks 1, 5 and 13 by intramuscular injection UB-312: A synthetic peptide-based vaccine | 0 | 7 | 0 | 7 | 7 | 7 |
| EG010 | Part B: Placebo | Placebo by intramuscular injection at Weeks 1, 5 and 13 Placebo: Matching placebo | 0 | 6 | 0 | 6 | 5 | 6 |
| Unprovoked Deep Venous Thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Urosepsis | Renal and urinary disorders | Non-systematic Assessment |
|
| Gastrointestinal Disorders | Gastrointestinal disorders | Systematic Assessment |
|
| General Disorders and Administration Site Conditions | General disorders | Systematic Assessment |
|
| Immune System Disorders | Immune system disorders | Systematic Assessment |
|
| Infections and Infestations | Immune system disorders | Systematic Assessment |
|
| Injury, Poisoning and Procedural Complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Muscoloskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nervous System Disorders | Nervous system disorders | Systematic Assessment |
|
| Psychiatric Disorders | Psychiatric disorders | Systematic Assessment |
|
| Renal and Urinary Disorders | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory, Thoracic and Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin and Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Surgical and Medical Procedures | Surgical and medical procedures | Systematic Assessment |
|
| Cardiac Disorders | Cardiac disorders | Systematic Assessment |
|
| Investigations | Investigations | Systematic Assessment |
|
| Metabolism and Nutrition Disorders | Metabolism and nutrition disorders | Systematic Assessment |
|
| Vascular Disorders | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |