Covid-19Phase 2/3NCT04683224
A Study to Evaluate the Safety, Immunogenicity, and Efficacy of UB-612 COVID-19 Vaccine
A Phase 2/3 study testing UB-612 in people with Covid-19 and SARS-CoV-2, run by Vaxxinity, Inc..
Trial summary
This is a Phase 2/3, randomized, multicenter, double-blind, dose-response study to evaluate the safety, immunogenicity, and efficacy of UB 612 in 2 age groups, adults 18 to 59 and ≥60 years of age with or without comorbidities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid-19, SARS-CoV-2, Coronavirus
- What is being tested?
- UB-612
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 22 Mar 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Understands and agrees to comply with the study procedures and provides written informed consent.
- Passes written comprehension test outlining study procedures.
- Male or female, aged 18 to 59 years or aged >60 years at randomization.
- Canadian Frailty Scale score of 0 to 6 (see Appendix 1).
- Women of childbearing potential (WOCBP) and men must agree to practice medically effective contraception from 28 days before the first vaccination until 1 month after the last vaccination (i.e., a 3-month period). The acceptable effective contraception methods include the following:
- Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide
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- Intrauterine device
- Prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or IM route
- Sterilization of a female participant's monogamous male partner prior to entry into the study
- Abstinence
- For WOCBP, serum pregnancy test must be negative at screening; urine pregnancy test must be negative within 24 hours before vaccination.
- Lactating female participants must agree not to breastfeed or store breast milk for 3 days after each vaccination. A substituted formula is recommended during these periods.
- Negative serum antibodies (IgG) against SARS-CoV-2 N protein at screening except for 300 subjects in the seropositive cohort (Phase 3 only).
- Negative result for RT-PCR screening of saliva or nasal mid-turbinate sample for SARS-CoV-2 within 2 days before vaccination.
- At high risk of SARS-CoV-2 exposure due to occupation (e.g., health care providers, first responders, service industry workers, etc.), residence (multi-generational home, long-term care facilities, etc.), or environment with high incidence (e.g., public transportation), including geographic area.
- Judged to be healthy or stable with pre-existing medical condition that did not require significant change in medication or hospitalization in 3 months before enrollment or who, in the judgement of the investigator are unlikely to require a significant change in therapy or hospitalization for worsening disease in the 3 months after enrollment.
- Must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) system.
- Plans to reside within study area for the duration of the study.
- Able to comply with study procedures, in the opinion of the investigator.
Who cannot join
- Positive for SARS-CoV-2 shedding or self-reported history of prior infection with SARS CoV-2.
- Seropositive for SARS-CoV-2, except for 300 subjects in the seropositive cohort in Phase 3 only.
- Moderate or severe illness and/or fever >100.4°F/38°C within 1 week before vaccination. Screening and/or study vaccination may be rescheduled at the discretion of the investigator.
- Canadian Frailty Scale score of ≥7 (see Appendix 1).
- History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions.
- Coronavirus vaccines: Previous receipt of SARS-CoV-2 vaccine or other investigational coronavirus vaccine (SARS-CoV, MERS-CoV) at any time.
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- Investigational non-coronavirus vaccines: Previous receipt of an investigational vaccine (non-coronavirus) within 1 year before the planned administration of the first dose of study vaccine.
- Licensed vaccines: Participant received or plans to receive: (a) licensed live attenuated vaccines or licensed adjuvanted (non-aluminum compound) vaccine within 28 days before or after planned administration of study vaccine, and (b) other licensed (not noted above) vaccines within 14 days before or after planned administration of study vaccine.
- Immunosuppressive or immunodeficient state, autoimmune diseases, chronic kidney disease (with dialysis), asplenia, recurrent severe infections.
- Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or planned receipt throughout the study.
- Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥20 mg/day of prednisone equivalent).
- Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening.
- Has donated ≥450 mL of blood products within 28 days prior to screening.
- Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days. However, participants who received specific anti-SARS-CoV-2 monoclonal antibody products (e.g., REGN-COV2) at any time are permanently excluded, even if such product was given as part of a normal volunteer study.
- Currently enrolled or plans to participate in another investigational study (drug, vaccine, or device) during this study.
- Pregnant.
- Lactating women who are unwilling or unable to withhold breastfeeding and storing milk for 3 days after each vaccination.
- Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
- Tattoos or scars at the deltoid sites of IM injection that would obscure injection site reactions.
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the Principal Investigator or his or her representative physician, affects the participant's ability to understand and cooperate with all study protocol requirements.
- Any alcohol or drug abuse over the 12 months prior to enrollment in the study that has caused medical, professional or family problems, indicated by clinical history.
- Any other condition that, in the opinion of the Principal Investigator or his/her representative physician, could put the safety/rights of potential participants at risk or prevent them from complying with the study protocol.
About this study
Official title: A Phase 2/3 Randomized, Multicenter, Double-Blind, Placebo Controlled, Dose-Response Study to Evaluate the Safety, Immunogenicity, and Efficacy of UB-612 Vaccine in Adults
This is a Phase 2/3, randomized, multicenter, double-blind, dose-response study to evaluate the safety, immunogenicity, and efficacy of UB 612 in 2 age groups, adults 18 to 59 and ≥60 years of age with or without comorbidities.
Read the detailed description
This Phase 2/3 trial will enroll a total of 7320 male and female subjects randomized in a double-blind manner to receive either UB-612 or placebo. Assignment will be stratified by age (18 to 59 years and ≥60 years) and by presence/absence of comorbidities.
All subjects will receive 2 doses of the study vaccine, separated by 28 days, as an intramuscular (IM) injection.
Phase 2 and Phase 3 will start simultaneously; Phase 2 will enroll all Strata #1 to #4; Phase 3 will enroll Stratum #1 until the Data and Safety Monitoring Board (DSMB) has reviewed Phase 2 data through Day 43 and endorsed enrolment of Strata #2 to #4. All subjects in Phase 2 and Phase 3 will be followed for safety and efficacy.
This Phase 2/3 study also contains a Safety and Immunogenicity Cohort (N=1300) consisting of 1000 SARS-CoV-2 seronegative subjects (320 subjects enrolled in Phase 2 and 680 subjects enrolled in Phase 3) and 300 SARS-CoV-2 seropositive subjects enrolled in Phase 3.
- Conditions
- Covid-19, SARS-CoV-2, Coronavirus
- Being tested
- UB-612, Placebo
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-612Biological
100 µg [microgram] of an experimental study vaccine
PlaceboOther
Placebo is a 0.9% sodium chloride (normal saline) injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo Stratum 1: 18 to 59 age group without comorbidities | Placebo comparator | Placebo by intramuscular injection at Day 1 and 29 Receives: Other: Placebo |
| UB-612 Stratum 1: 18 to 59 age group without comorbidities | Experimental | UB-612 by intramuscular injection at Day 1 and 29 Receives: Biological: UB-612 |
| Placebo Stratum 2: ≥60 age group without comorbidities | Placebo comparator | Placebo by intramuscular injection at Day 1 and 29 Receives: Other: Placebo |
| UB-612 Stratum 2: ≥60 age group without comorbidities | Experimental | UB-612 by intramuscular injection at Day 1 and 29 Receives: Biological: UB-612 |
| Placebo Stratum 3: 18 to 59 age group with comorbidities | Placebo comparator | Placebo by intramuscular injection at Day 1 and 29 Receives: Other: Placebo |
| UB-612 Stratum 3: 18 to 59 age group with comorbidities | Experimental | UB-612 by intramuscular injection at Day 1 and 29 Receives: Biological: UB-612 |
| Placebo Stratum 4: ≥60 age group with comorbidities | Placebo comparator | Placebo by intramuscular injection at Day 1 and 29 Receives: Other: Placebo |
| UB-612 Stratum 4: ≥60 age group with comorbidities | Experimental | UB-612 by intramuscular injection at Day 1 and 29 Receives: Biological: UB-612 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of local reactions, solicited systemic events, AEs, MAAEs, SAEs and AESIs
Safety and Tolerability
Measured: Day 1 to 24 months
Change in safety chemistry blood lab values for assessment of risk in Phase 3
Percentage of subjects with changes in lab values at different time points
Measured: Phase 2 -Day 1 to Day 36
Change in safety hematology blood lab values for assessment of risk in Phase 3
Percentage of subjects with changes in lab values at different time points
Measured: Phase 2 -Day 1 to Day 36
Prevention of SARS-CoV-2 infection in adults
SARS-CoV-2 incidence based on qPCR nasopharyngeal swab
Measured: Day 29 to 24 Month
Change after second dose through the end of study in antibody titers
Immunogenicity of UB-612 vaccine
Measured: Month 1, 6, 12 and 24 following Dose 2
Secondary outcomes (5)
Prevention of COVID-19 in adults
COVID-19 incidence confirmed by qPCR nasopharyngeal swab
Measured: Day 42 to 24 Month
Reduction in severity of COVID-19 in adults
Efficacy of UB-612 vaccine
Measured: Day 42 to 24 Month
Prevention of COVID-19 death in adults
Efficacy of UB-612 vaccine
Measured: Day 42 to 24 Month
Change in SARS CoV-2 shedding
Measured by comparing the SARS-CoV-2 shedding in vaccine and placebo subjects
Measured: Day 42 to 24 Month
Immunogenicity of UB-612 vaccine in young and older adults, with or without comorbidities, and no serological or virological evidence of past infection with SARS-CoV-2
Number of cytokine secreting spots
Measured: baseline, 7 days, 6, 12, and 24 months after Dose 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Feb 2021 (estimated)
- Primary completion22 Mar 2023 (estimated)
- Study completion22 Mar 2023 (estimated)
Why it stopped: Study was withdrawn due to redesign of the protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaxxinity, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Diagnósticos da América S/A (DASA)
- Responsible party
- Sponsor
- Investigators
- Gray Heppner, Study chair, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683224
- Sponsor's protocol ID
- UB-612-301
- Status last verified
- Mar 2022
- First submitted
- 10 Dec 2020
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3 Randomized, Multicenter, Double-Blind, Placebo Controlled, Dose-Response Study to Evaluate the Safety, Immunogenicity, and Efficacy of UB-612 Vaccine in Adults
- ClinicalTrials.gov ID
- NCT04683224
- Acronym / sponsor ID
- UB-612-301
- Conditions
- Covid-19, SARS-CoV-2, Coronavirus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn due to redesign of the protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vaxxinity, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Diagnósticos da América S/A (DASA)
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 22 Mar 2023 (estimated)
- Study completion
- 22 Mar 2023 (estimated)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2/3, randomized, multicenter, double-blind, dose-response study to evaluate the safety, immunogenicity, and efficacy of UB 612 in 2 age groups, adults 18 to 59 and ≥60 years of age with or without comorbidities.
Detailed description
This Phase 2/3 trial will enroll a total of 7320 male and female subjects randomized in a double-blind manner to receive either UB-612 or placebo. Assignment will be stratified by age (18 to 59 years and ≥60 years) and by presence/absence of comorbidities.
All subjects will receive 2 doses of the study vaccine, separated by 28 days, as an intramuscular (IM) injection.
Phase 2 and Phase 3 will start simultaneously; Phase 2 will enroll all Strata #1 to #4; Phase 3 will enroll Stratum #1 until the Data and Safety Monitoring Board (DSMB) has reviewed Phase 2 data through Day 43 and endorsed enrolment of Strata #2 to #4. All subjects in Phase 2 and Phase 3 will be followed for safety and efficacy.
This Phase 2/3 study also contains a Safety and Immunogenicity Cohort (N=1300) consisting of 1000 SARS-CoV-2 seronegative subjects (320 subjects enrolled in Phase 2 and 680 subjects enrolled in Phase 3) and 300 SARS-CoV-2 seropositive subjects enrolled in Phase 3.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Placebo Stratum 1: 18 to 59 age group without comorbidities | Placebo comparator | Other: PlaceboPlacebo by intramuscular injection at Day 1 and 29 |
| UB-612 Stratum 1: 18 to 59 age group without comorbidities | Experimental | Biological: UB-612UB-612 by intramuscular injection at Day 1 and 29 |
| Placebo Stratum 2: ≥60 age group without comorbidities | Placebo comparator | Other: PlaceboPlacebo by intramuscular injection at Day 1 and 29 |
| UB-612 Stratum 2: ≥60 age group without comorbidities | Experimental | Biological: UB-612UB-612 by intramuscular injection at Day 1 and 29 |
| Placebo Stratum 3: 18 to 59 age group with comorbidities | Placebo comparator | Other: PlaceboPlacebo by intramuscular injection at Day 1 and 29 |
| UB-612 Stratum 3: 18 to 59 age group with comorbidities | Experimental | Biological: UB-612UB-612 by intramuscular injection at Day 1 and 29 |
| Placebo Stratum 4: ≥60 age group with comorbidities | Placebo comparator | Other: PlaceboPlacebo by intramuscular injection at Day 1 and 29 |
| UB-612 Stratum 4: ≥60 age group with comorbidities | Experimental | Biological: UB-612UB-612 by intramuscular injection at Day 1 and 29 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Understands and agrees to comply with the study procedures and provides written informed consent.
- Passes written comprehension test outlining study procedures.
- Male or female, aged 18 to 59 years or aged >60 years at randomization.
- Canadian Frailty Scale score of 0 to 6 (see Appendix 1).
- Women of childbearing potential (WOCBP) and men must agree to practice medically effective contraception from 28 days before the first vaccination until 1 month after the last vaccination (i.e., a 3-month period). The acceptable effective contraception methods include the following:
Key exclusion criteria (22 listed)
- Positive for SARS-CoV-2 shedding or self-reported history of prior infection with SARS CoV-2.
- Seropositive for SARS-CoV-2, except for 300 subjects in the seropositive cohort in Phase 3 only.
- Moderate or severe illness and/or fever >100.4°F/38°C within 1 week before vaccination. Screening and/or study vaccination may be rescheduled at the discretion of the investigator.
- Canadian Frailty Scale score of ≥7 (see Appendix 1).
- History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UB-612100 µg [microgram] of an experimental study vaccine | Biological | UB-612 Stratum 1: 18 to 59 age group without comorbidities, UB-612 Stratum 2: ≥60 age group without comorbidities, UB-612 Stratum 3: 18 to 59 age group with comorbidities, UB-612 Stratum 4: ≥60 age group with comorbidities |
| PlaceboPlacebo is a 0.9% sodium chloride (normal saline) injection | Other | Placebo Stratum 1: 18 to 59 age group without comorbidities, Placebo Stratum 2: ≥60 age group without comorbidities, Placebo Stratum 3: 18 to 59 age group with comorbidities, Placebo Stratum 4: ≥60 age group with comorbidities |
Primary outcome
The incidence of local reactions, solicited systemic events, AEs, MAAEs, SAEs and AESIs
Time frame: Day 1 to 24 months
Safety and Tolerability
Change in safety chemistry blood lab values for assessment of risk in Phase 3
Time frame: Phase 2 -Day 1 to Day 36
Percentage of subjects with changes in lab values at different time points
Change in safety hematology blood lab values for assessment of risk in Phase 3
Time frame: Phase 2 -Day 1 to Day 36
Percentage of subjects with changes in lab values at different time points
Prevention of SARS-CoV-2 infection in adults
Time frame: Day 29 to 24 Month
SARS-CoV-2 incidence based on qPCR nasopharyngeal swab
Change after second dose through the end of study in antibody titers
Time frame: Month 1, 6, 12 and 24 following Dose 2
Immunogenicity of UB-612 vaccine
5 secondary outcomes
Prevention of COVID-19 in adults
Time frame: Day 42 to 24 Month
Reduction in severity of COVID-19 in adults
Time frame: Day 42 to 24 Month
Prevention of COVID-19 death in adults
Time frame: Day 42 to 24 Month
Change in SARS CoV-2 shedding
Time frame: Day 42 to 24 Month
Immunogenicity of UB-612 vaccine in young and older adults, with or without comorbidities, and no serological or virological evidence of past infection with SARS-CoV-2
Time frame: baseline, 7 days, 6, 12, and 24 months after Dose 2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gray Heppner study chair
Chief Medical Officer
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing UB-612 in people with Covid-19 and SARS-CoV-2, run by Vaxxinity, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of local reactions, solicited systemic events, AEs, MAAEs, SAEs and AESIs (time frame: Day 1 to 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.