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Virus Vaccine
Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost With UB-612 Vaccine
Phase 3
Waitlist Available
Research Sponsored by Vaxxinity, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 15 and 29, and months 6 and 12
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests a new COVID-19 vaccine called UB-612 as a booster shot for people who were vaccinated with a different COVID-19 vaccine some time ago. The goal is to see if this booster can improve their immune response.
Eligible Conditions
- Coronavirus Vaccines
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1, 15 and 29, and months 6 and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 15 and 29, and months 6 and 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Boost in neutralizing antibody titers against Wuhan strain at Day 29
Presence of adverse events of special interest
Presence of medically attended adverse events
+3 moreSecondary study objectives
Boost in neutralizing antibody titers against Omicron strain at Day 29
Kinetics and duration of antibody response - AUC via binding to S1-RBD
Kinetics and duration of antibody response - AUC via neutralizing antibodies
+10 moreOther study objectives
Ability to boost cellular immunity
Ability to boost humoral immunity (neutralizing) against additional variant - GMFI via neutralizing antibodies
Ability to boost humoral immunity (neutralizing) against additional variant - GMR via neutralizing antibodies
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: open-label UB-612 boost of BNT162b2Experimental Treatment1 Intervention
A single injection of UB-612 on Day 1 in an open-label fashion in subjects who completed the primary immunization series with BNT162b2.
Group II: double-blind UB-612 boost of Sinopharm BIBPExperimental Treatment1 Intervention
A single injection of UB-612 on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with Sinopharm BIBP.
Group III: double-blind UB-612 boost of ChAdOx1-SExperimental Treatment1 Intervention
A single injection of UB-612 on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with ChAdOx1-S.
Group IV: double-blind UB-612 boost of BNT162b2Experimental Treatment1 Intervention
A single injection of UB-612 on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with BNT162b2
Group V: open-label BNT162b2 boostActive Control1 Intervention
A single injection of BNT162b2 on Day 1 in an open-label fashion in subjects who completed the primary immunization series with BNT162b2.
Group VI: double-blind ChAdOx1-S boostActive Control1 Intervention
A single injection of ChAdOx1-S on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with ChAdOx1-S.
Group VII: double-blind BNT162b2 boostActive Control1 Intervention
A single injection of BNT162b2 on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with BNT162b2.
Group VIII: double-blind Sinopharm BIBPActive Control1 Intervention
A single injection of Sinopharm BIBP on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with Sinopharm BIBP.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
UB-612
2020
Completed Phase 1
~110
Find a Location
Who is running the clinical trial?
Vaxxinity, Inc.Lead Sponsor
7 Previous Clinical Trials
4,161 Total Patients Enrolled
Syneos HealthOTHER
176 Previous Clinical Trials
67,711 Total Patients Enrolled
Coalition for Epidemic Preparedness InnovationsOTHER
36 Previous Clinical Trials
75,007 Total Patients Enrolled