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Virus Vaccine

UB-612 for Coronavirus Vaccines

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

Study Summary

This trial is testing a new COVID-19 vaccine (UB-612) against other existing COVID-19 vaccines to see if it is safe and effective.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 15 and 29, and months 6 and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

Secondary outcome measures

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 more

Other outcome measures

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 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vaxxinity, Inc.Lead Sponsor

7 Previous Clinical Trials

4,161 Total Patients Enrolled

Syneos HealthOTHER

172 Previous Clinical Trials

67,510 Total Patients Enrolled

Coalition for Epidemic Preparedness InnovationsOTHER

35 Previous Clinical Trials

74,404 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for willing test subjects?

"Unfortunately, this particular clinical trial is not currently recruiting patients. The study was initially posted on March 16th but has not been updated since October 11th of this year. There are 1,127 other trials that are still enrolling patients though."

Answered by AI

What are the objectives of this research?

"The primary outcome for this study, which will be evaluated 387 days after participants receive the experimental vaccine, is the presence of local or systemic reactions not detailed in the trial information. Additionally, this clinical trial will also assess secondary outcomes on day 29 including the proportion of subjects that respond to both Omicron and Wuhan strains with a 4-fold or greater increase in antibody titer as well as the kinetics and duration of the antibody response."

Answered by AI

Is UB-612 a reliable medication with few side effects?

"UB-612 has received a score of 3 for safety. This is based on the fact that it is a Phase 3 trial, which suggests that not only does some data support efficacy, but multiple rounds of data also support safety."

Answered by AI

Recent research and studies

VaccinesJournal

Safety and Immunogenicity of the Third Booster Dose with Inactivated, Viral Vector, and Mrna COVID-19 Vaccines in Fully Immunized Healthy Adults with Inactivated Vaccine

Kanokudom, Sitthichai, Suvichada Assawakosri, Nungruthai Suntronwong, Chompoonut Auphimai, Pornjarim Nilyanimit, Preeyaporn Vichaiwattana, Thanunrat Thongmee, et al.. 2022. “Safety and Immunogenicity of the Third Booster Dose with Inactivated, Viral Vector, and Mrna COVID-19 Vaccines in Fully Immunized Healthy Adults with Inactivated Vaccine”. Vaccines. MDPI AG. doi:10.3390/vaccines10010086.

The LancetJournal

A Novel Coronavirus Outbreak of Global Health Concern

Wang, Chen, Peter W Horby, Frederick G Hayden, and George F Gao. 2020. “A Novel Coronavirus Outbreak of Global Health Concern”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(20)30185-9.

The LancetJournal

Reactogenicity and Immunogenicity After a Late Second Dose or a Third Dose of Chadox1 Ncov-19 in the UK: A Substudy of Two Randomised Controlled Trials (COV001 and COV002)

Flaxman, Amy, Natalie G Marchevsky, Daniel Jenkin, Jeremy Aboagye, Parvinder K Aley, Brian Angus, Sandra Belij-Rammerstorfer, et al.. 2021. “Reactogenicity and Immunogenicity After a Late Second Dose or a Third Dose of Chadox1 Ncov-19 in the UK: A Substudy of Two Randomised Controlled Trials (COV001 and COV002)”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(21)01699-8.

Clinical Microbiology and InfectionJournal