NCT04075318

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

August 29, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 6, 2025

Completed
Last Updated

March 6, 2025

Status Verified

February 1, 2025

Enrollment Period

3.5 years

First QC Date

August 5, 2019

Results QC Date

July 10, 2024

Last Update Submit

February 28, 2025

Conditions

Parkinson's DiseaseParkinsonism

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (11)

Part A: UB-312 40 mcg

EXPERIMENTAL

UB-312 40 mcg by intramuscular injection at Weeks 1, 5 and 13

Biological: UB-312

Part A: UB-312 100 mcg

EXPERIMENTAL

UB-312 100 mcg by intramuscular injection at Weeks 1, 5 and 13

Biological: UB-312

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

Biological: UB-312

Part A: UB-312 300 mcg

EXPERIMENTAL

UB-312 300 mcg by intramuscular injection at Weeks 1, 5 and 13

Biological: UB-312

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

Biological: UB-312

Part A: UB-312 1000 mcg

EXPERIMENTAL

UB-312 1000 mcg by intramuscular injection at Weeks 1, 5 and 13

Biological: UB-312

Part A: UB-312 2000 mcg

EXPERIMENTAL

UB-312 2000 mcg by intramuscular injection at Weeks 1, 5 and 13

Biological: UB-312

Part A: Placebo

PLACEBO COMPARATOR

Placebo by intramuscular injection at Weeks 1, 5 and 13

Biological: Placebo

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

Biological: UB-312

Part B: UB-312 300 mcg

EXPERIMENTAL

UB-312 300 mcg at Weeks 1, 5 and 13 by intramuscular injection

Biological: UB-312

Part B: Placebo

PLACEBO COMPARATOR

Placebo by intramuscular injection at Weeks 1, 5 and 13

Biological: Placebo

Interventions

UB-312BIOLOGICAL

A synthetic peptide-based vaccine

Part A: UB-312 100 mcgPart A: UB-312 1000 mcgPart A: UB-312 2000 mcgPart A: UB-312 300 mcgPart A: UB-312 40 mcgPart A: UB-312 40/1000 mcgPart A: UB-312 40/300 mcgPart B: UB-312 300 mcgPart B: UB-312 300/100 mcg
PlaceboBIOLOGICAL

Matching placebo

Part A: PlaceboPart B: Placebo

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 40 to 85 years old, inclusive at screening
  • Expected to be able to undergo all study procedures
  • For Part B only:
  • A diagnosis of PD, confirmed by a neurologist
  • Hoehn \&Yahr Stage ≤ III at Screening
  • Stable treatment of permitted antiparkinsonian medications from 30 days prior to first study drug administration or 60 days for MAO-B inhibitors, and expected to remain stable throughout the study

You may not qualify if:

  • Clinically significant abnormalities, as judged by the investigator
  • History of medical, neurological or psychiatric conditions which in the opinion of the investigator may compromise participant's safety or scientific value of the study
  • Acute or chronic infection as judged by the investigator, for positive human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV)
  • History or evidence of an autoimmune disorder
  • History of anergy.
  • Participated/participating in any clinical trial with monoclonal antibodies or vaccines directed at aSyn
  • For Part B only:
  • Other known or suspected cause of Parkinsonism other than idiopathic PD
  • History or evidence at Screening of PD-related freezing episodes, falls, or orthostatic hypotension
  • Dopamine transporter single-photon emission computerized tomography scan (DaTscan) inconsistent with dopamine transporter deficit.
  • Clinically significant neurological disease other than PD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Human Drug Research

Leiden, Netherlands

Location

Related Publications (5)

  • 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.

    PMID: 15755569BACKGROUND

  • 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.

    PMID: 17287052BACKGROUND

  • 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.

    PMID: 29067332BACKGROUND

  • 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.

    PMID: 38902546RESULT

  • 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.

    PMID: 35426173RESULT

MeSH Terms

Conditions

Parkinson DiseaseParkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Executive Director, Clinical Development
Organization
Vaxxinity, Inc.
info@vaxxinity.com
254-244-5739

Study Officials

  • Medical Director, MD

    Vaxxinity, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 30, 2019

Study Start

August 29, 2019

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

March 6, 2025

Results First Posted

March 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)