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UB-312 Vaccine for Parkinson's & Multiple System Atrophy
Phase 1 & 2
Recruiting
Led By Horacio Kaufmann, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female aged 40 to 75 years old, inclusive, at screening.
A diagnosis of PD or MSA, confirmed by the PI, as per the current Movement Disorders Society's criteria (Postuma 2015, Wenning 2022).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, week 133
Awards & highlights
Study Summary
This trial will test the safety of a potential vaccine for Parkinson's and Multiple System Atrophy.
Who is the study for?
This trial is for adults aged 40-75 with Parkinson's Disease or Multiple System Atrophy, confirmed by specific criteria. Participants must have a certain cognitive score, be within a specified weight range, and agree to use contraception if of childbearing potential. They should not have had recent investigational drug use, significant allergies, autoimmune disorders, or conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial tests UB-312 Injection against a placebo in patients with synucleinopathies like Parkinson's Disease and Multiple System Atrophy. UB-312 is an experimental vaccine aimed at providing active immunotherapy for these conditions. The study will assess safety, tolerability, and immune response.See study design
What are the potential side effects?
As this is an early-phase trial primarily assessing safety and tolerability of UB-312 Injection (a synthetic peptide-based vaccine), detailed side effects are being determined but may include typical vaccine reactions such as soreness at injection site, fever, fatigue or allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 75 years old.
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I have been diagnosed with Parkinson's disease or Multiple System Atrophy.
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My BMI is between 18 and 32, and I weigh at least 50 kg.
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I am a male willing to use contraception during the study and for 90 days after, and will not donate sperm.
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My mental function score is above 21.
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I am fully vaccinated and boosted for COVID-19 as per local guidelines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, week 133
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, week 133
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in CSF Levels of anti-aSyn Antibodies from First Injection
Change in Serum Levels of anti-aSyn Antibodies from First Injection
Trial Design
4Treatment groups
Experimental Treatment
Group I: Treatment First - PDExperimental Treatment2 Interventions
Includes participants with PD only.
Patients in the treatment-first arm will receive active treatment at weeks 1, 5, 13, 25, 37, 49, 73, and 97; and placebo doses at weeks 17, 61, 85, and 109. Participants will be followed up for 24 weeks after their last dose.
All participants will receive three priming doses of UB-312 300 µg, followed by 5 booster doses of UB-312 300 µg. To keep the blind, both treatment arms will receive active treatment and placebo injections for a total of 12 injections (8 active treatment injections + 4 placebo injections).
Group II: Treatment First - MSAExperimental Treatment2 Interventions
Includes participants with MSA only.
Patients in the treatment-first arm will receive active treatment at weeks 1, 5, 13, 25, 37, 49, 73, and 97; and placebo doses at weeks 17, 61, 85, and 109. Participants will be followed up for 24 weeks after their last dose.
All participants will receive three priming doses of UB-312 300 µg, followed by 5 booster doses of UB-312 300 µg. To keep the blind, both treatment arms will receive active treatment and placebo injections for a total of 12 injections (8 active treatment injections + 4 placebo injections).
Group III: Delayed Start - PDExperimental Treatment2 Interventions
Includes participants with PD only.
Patients in the delayed-start arm will receive placebo injections at weeks 1, 5, 73, and 97; and active treatment at weeks 13, 17, 25, 37, 49, 61, 85, and 109. Participants will be followed up for 24 weeks after their last dose.
All participants will receive three priming doses of UB-312 300 µg, followed by 5 booster doses of UB-312 300 µg. To keep the blind, both treatment arms will receive active treatment and placebo injections for a total of 12 injections (8 active treatment injections + 4 placebo injections).
Group IV: Delayed Start - MSAExperimental Treatment2 Interventions
Includes participants with MSA only
Patients in the delayed-start arm will receive placebo injections at weeks 1, 5, 73, and 97; and active treatment at weeks 13, 17, 25, 37, 49, 61, 85, and 109. Participants will be followed up for 24 weeks after their last dose.
All participants will receive three priming doses of UB-312 300 µg, followed by 5 booster doses of UB-312 300 µg. To keep the blind, both treatment arms will receive active treatment and placebo injections for a total of 12 injections (8 active treatment injections + 4 placebo injections).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo Injection
2017
Completed Phase 4
~3710
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,372 Previous Clinical Trials
841,102 Total Patients Enrolled
5 Trials studying Multiple System Atrophy
1,082 Patients Enrolled for Multiple System Atrophy
Horacio Kaufmann, MDPrincipal InvestigatorNYU Langone Health
9 Previous Clinical Trials
1,051 Total Patients Enrolled
1 Trials studying Multiple System Atrophy
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 40 and 75 years old.I have been diagnosed with Parkinson's disease or Multiple System Atrophy.You have had problems with drug or alcohol addiction in the past 2 years.You have had severe allergic reactions to medication or vaccines, or have multiple drug allergies.I have received a blood transfusion or blood products within the last 3 months.You have a history of certain autoimmune disorders that could make participating in the study risky for you.My Parkinson's symptoms are not caused by drugs, toxins, or other conditions like essential tremor.My BMI is between 18 and 32, and I weigh at least 50 kg.Your test results for liver, kidney, blood, and other health indicators are not within normal range, unless the doctor thinks it's not a big concern. If the results are uncertain, they may be rechecked before you can join the study.I haven't been vaccinated within 2 weeks before my screening, and I will discuss future vaccinations with my doctor.I do not have HIV, hepatitis B or C, or any condition that weakens my immune system.I am either not able to have children, use birth control, or am postmenopausal.I have been in a trial for treatments targeting aSyn with antibodies or vaccines.I am a male willing to use contraception during the study and for 90 days after, and will not donate sperm.My mental function score is above 21.I do not have metal implants or fragments that prevent me from having an MRI.I haven't taken any forbidden medications recently and no long-term immune system drugs in the last 6 months.History of lack of immune response.You have tested positive for COVID-19 within the 2 weeks before starting the study.I haven't lost or donated more than 500 mL of blood in the last 3 months.I have not had brain surgery, device implantation in the brain, or stem cell studies.My only cancers in the past 5 years were skin cancers that were removed.My Parkinson's medication has been stable for at least 30 days, or 60 days for MAO-B inhibitors.You are pregnant, as confirmed by a positive pregnancy test.I am fully vaccinated and boosted for COVID-19 as per local guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment First - PD
- Group 2: Delayed Start - PD
- Group 3: Delayed Start - MSA
- Group 4: Treatment First - MSA
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor include individuals who are aged 35 or older?
"Patients aged between 40 and 75 are eligible for this research protocol."
Answered by AI
What are the qualifications for participation in this clinical experiment?
"To be included in this clinical trial, applicants must have been diagnosed with Parkinson's disease and fall into the age range of 40 to 75 years old. A maximum 8 patients are being accepted."
Answered by AI
Are there any vacancies for participants in this research endeavor?
"Clinicaltrials.gov data indicates that this trial is not recruiting patients at present, despite being posted on December 15th 2022 and edited as recently as November 23rd 2022. Nevertheless, 509 additional clinical trials are actively enrolling participants right now."
Answered by AI
Who else is applying?
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I'm in hopes for a cure and I am willing to help find it. My medication sometimes works well and sometimes doesn't. I hope something like this vaccine can slow the deterioration.
PatientReceived no prior treatments
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