COVID-19Phase 1NCT05167253
A Study to Evaluate the Ability of UB-612 COVID-19 Vaccine to Boost Immunity of Heterologous COVID-19 Vaccines.
A Phase 1 study testing UB-612 in people with COVID-19, run by United Biomedical Inc., Asia.
Trial summary
This is a study to evaluate the ability of UB-612 vaccine to boost immunity of subjects who previously received two doses of AstraZeneca COVID-19 vaccine (ChAdOx1-S) with an 8-16 week interval between first and second doses. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- UB-612
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2022to 31 Oct 2022
- Phase
- Phase 1
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or non-pregnant female between the age of 20 and 55 years at time of enrolment.
- Fully vaccinated with two injections of AstraZeneca COVID-19 vaccine (ChAdOx1-S) with an 8-16 week interval between first and second doses. The second dose of AstraZeneca COVID-19 vaccine (ChAdOx1-S) must have been administered more than six (6) months from study Day 1. The CDC COVID-19 Vaccination Record Card or appropriate documentation (e.g., medical records) will be required for documentation.
- Women of childbearing potential and men must agree to practice medically effective contraception from vaccination until 30 days after the vaccination.
- Participant or the participant's legal representative must understand the procedures of the study and is willing to sign the Informed Consent Form (ICF).
- Able to understand and agrees to comply with all study procedures and be available for all study visits.
- Must be able to read, understand, and complete the protocol-required questionnaires and/or diary.
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- Negative serological test for Hepatitis B surface antigen (HBsAg), HCV RNA and HIV antibody
- Negative results of SARS-CoV-2 N protein IgG ELISA
- Negative result of RT-PCR screening of nasopharyngeal or throat swabs for SARS-CoV-2.
- Ear temperature ≤ 38.0°C.
- Indexes of hematology, biochemistry and immunology laboratory tests are within the normal ranges, or not clinically significant as judged by investigators
Who cannot join
- History of anaphylaxis, urticarial, or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
- Female who is pregnant or positive in pregnancy test at screening or just prior to vaccination administration or plans to become pregnant from the time of study vaccination through 30 days after the administration of the study vaccine.
- Female who is breast-feeding or plans to breastfeed from the time of the study vaccination through 30 days after the administration of the study vaccine.
- Investigational non-coronavirus vaccines: previous receipt of an investigational vaccine (non-coronavirus) within 1 year before the planned administration of study vaccine.
- Prior administration of attenuated, nucleic acid (mRNA or DNA) or vectored vaccines in last 1 month before the study vaccine or expectation of such vaccines in the month after the study vaccine.
- Prior administration of subunit vaccine or inactivated vaccine in last 14 days before the study vaccine or expectation of receipt of such vaccines in the 14 days after the study vaccine.
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- Judged by the investigator on the basis of evidence or medical history, immunosuppressive or immunodeficient state, autoimmune diseases, chronic kidney disease (with dialysis), asplenia, or recurrent severe infections.
- Prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before the study vaccination.
- Receipt of short-term systemic corticosteroids. Study intervention administration should be delayed until systemic corticosteroid use has been discontinued for at least 28 days. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
- Has received systemic immunoglobulins or blood products within 4 months prior to enrollment.
- Loss or donation of blood over 500 mL within 3 months prior to screening visit or intention to donate blood or blood products for transfusion during the study.
- Participants who received specific anti-SARS-CoV-2 monoclonal antibody products at any time.
- Subjects who take part in another clinical study and are currently receiving or received any investigational intervention within 12 weeks prior to the day of informed consent.
- Platelet disorder or other bleeding disorder may cause injection contraindication.
- Any acute illness, as determined by the study investigator 3 days before vaccination.
- Judged by the investigator on the basis of evidence or medical history, participants with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies) will be excluded.
- History of malignancy within 5 years prior to screening visit, except basal cell carcinoma of the skin and cervical carcinoma in situ.
- Known history of SARS, MERS or SARS-CoV-2 infection.
- Alcoholism or substance abuser.
- Behavioral, cognitive, or psychiatric disease that, in the opinion of investigators, affects the participant's ability to understand and cooperate with all study protocol requirements.
- Employees at the investigator's site, of the Sponsor or the contract research organization (CRO) directly involved in the conduct of the study.
About this study
Official title: A Phase I, Open-label Study to Evaluate the Ability of UB-612 Vaccine to Boost Immunity of Heterologous COVID-19 Vaccines
This is a study to evaluate the ability of UB-612 vaccine to boost immunity of subjects who previously received two doses of AstraZeneca COVID-19 vaccine (ChAdOx1-S) with an 8-16 week interval between first and second doses.
Read the detailed description
This is a phase I, open-label clinical study to evaluate the ability of UB-612 vaccine to boost immunity of subjects who previously received two doses of AstraZeneca COVID-19 vaccine (ChAdOx1-S) with an 8-16 week interval between first and second doses.
This study will enroll approximately 30 subjects aged 20 to 55 years. The previous COVID-19 vaccine series will have been completed at least six months before study enrollment. Both sexes should be evenly distributed in subjects.
Subjects will be enrolled to receive one dose of 100 μg UB-612 vaccine at Day 1. The subjects will come to the clinics at Visit 1 (screening, Day -28 to -1), Visit 2 (Day 1, vaccination), Visit 3 (Day 15, 14 days after vaccination), Visit 4 (Day 29, 28 days after vaccination), Visit 5 (Day 169, 6 months after vaccination) and will receive phone calls at 7 days after vaccination for safety check.
- Conditions
- COVID-19
- Being tested
- UB-612
- Keywords
- SARS-CoV-2; COVID-19 Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-612Biological
UB-612 includes a designer S1-RBD-sFc fusion protein formulated with designer Th and CTL epitope peptides selected from immunodominant M, S2 and N regions known to bind to human MHC I and II.
| Study group | Role | What they receive |
|---|---|---|
| UB-612 100 μg, 0.5 mL | Experimental | All subjects will be enrolled to receive one dose of 100 μg UB-612 vaccine Receives: Biological: UB-612 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
- Local solicited adverse events
- Systemic solicited adverse events
- Skin allergic reactions
Measured: within 7 days after vaccination
Safety and tolerability
- Unsolicited adverse events
Measured: 28 days after vaccination
Immunogenicity
- Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild type
Measured: 14 days after vaccination
Immunogenicity
- Seroconversion rate (SCR) of neutralizing antibody against SARS-CoV-2 wild type
Measured: 14 days after vaccination
Immunogenicity
- Geometric mean fold increase (GMFI) of neutralizing antibody against SARS-CoV-2 wild type
Measured: 14 days after vaccination
Secondary outcomes (24)
Safety
- Adverse events)
- AE of special interest
- Vaccine-associated enhanced disease
- Serious adverse events
- Medically attended adverse events
Measured: Day 1
Safety
- Adverse events)
- AE of special interest
- Vaccine-associated enhanced disease
- Serious adverse events
- Medically attended adverse events
Measured: 14 days after vaccination
Safety
- Adverse events)
- AE of special interest
- Vaccine-associated enhanced disease
- Serious adverse events
- Medically attended adverse events
Measured: 28 days after vaccination
Safety
- Adverse events)
- AE of special interest
- Vaccine-associated enhanced disease
- Serious adverse events
- Medically attended adverse events
Measured: 6 months after vaccination
Evaluation of safety of hematology and biochemistry
Change of safety laboratory measurement from pre-vaccination
Measured: Pre-vaccination
Immunogenicity
- GMT of neutralizing antibody against SARS-CoV-2 wild type, antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Measured: 14 days after vaccination
Immunogenicity
- SCR of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Measured: 14 days after vaccination
Immunogenicity
- GMFI of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Measured: 14 days after vaccination
Immunogenicity
- GMT of neutralizing antibody against SARS-CoV-2 wild type, antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Measured: 28 days after vaccination
Immunogenicity
- SCR of neutralizing antibody against SARS-CoV-2 wild type, antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Measured: 28 days after vaccination
Immunogenicity
- GMFI of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Measured: 28 days after vaccination
Immunogenicity
- GMT of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Measured: 6 months after vaccination
Immunogenicity
- SCR of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Measured: 6 months after vaccination
Immunogenicity
- GMFI of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Measured: 6 months after vaccination
Immunogenicity
- GMT of neutralizing antibody titers against SARS-CoV-2 variant
Measured: 14 days after vaccination
Immunogenicity
- SCR of neutralizing antibody titers against SARS-CoV-2 variant
Measured: 14 days after vaccination
Immunogenicity
- GMFI of neutralizing antibody titers against SARS-CoV-2 variant
Measured: 14 days after vaccination
Immunogenicity
- Reduction fold of GMT compared with neutralizing antibody titers against SARS-CoV-2 wild type
Measured: 14 days after vaccination
Immunogenicity
- GMT of neutralizing antibody titers against SARS-CoV-2 variant
Measured: 28 days after vaccination
Immunogenicity
- SCR of neutralizing antibody titers against SARS-CoV-2 variant
Measured: 28 days after vaccination
Immunogenicity
- GMFI of neutralizing antibody titers against SARS-CoV-2 variant
Measured: 28 days after vaccination
Immunogenicity
- Reduction fold of GMT compared with neutralizing antibody titers against SARS-CoV-2 wild type
Measured: 28 days after vaccination
Immunogenicity
- T cell responses
Measured: Day 1
Immunogenicity
- T cell responses
Measured: 14 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start15 Feb 2022 (estimated)
- Primary completion15 Apr 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Why it stopped: Regulatory issues raised by the regulatory authority in Taiwan.
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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Biomedical Inc., Asia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chang-Yi Wang, Ph.D., Study chair, United Biomedical Inc., Asia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167253
- Sponsor's protocol ID
- V-125
- Status last verified
- Feb 2022
- First submitted
- 16 Dec 2021
- Last updated
- 26 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Study to Evaluate the Ability of UB-612 Vaccine to Boost Immunity of Heterologous COVID-19 Vaccines
- ClinicalTrials.gov ID
- NCT05167253
- Acronym / sponsor ID
- V-125
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2; COVID-19 Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Regulatory issues raised by the regulatory authority in Taiwan.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United Biomedical Inc., AsiaIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (estimated)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 22 Dec 2021 (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 study to evaluate the ability of UB-612 vaccine to boost immunity of subjects who previously received two doses of AstraZeneca COVID-19 vaccine (ChAdOx1-S) with an 8-16 week interval between first and second doses.
Detailed description
This is a phase I, open-label clinical study to evaluate the ability of UB-612 vaccine to boost immunity of subjects who previously received two doses of AstraZeneca COVID-19 vaccine (ChAdOx1-S) with an 8-16 week interval between first and second doses.
This study will enroll approximately 30 subjects aged 20 to 55 years. The previous COVID-19 vaccine series will have been completed at least six months before study enrollment. Both sexes should be evenly distributed in subjects.
Subjects will be enrolled to receive one dose of 100 μg UB-612 vaccine at Day 1. The subjects will come to the clinics at Visit 1 (screening, Day -28 to -1), Visit 2 (Day 1, vaccination), Visit 3 (Day 15, 14 days after vaccination), Visit 4 (Day 29, 28 days after vaccination), Visit 5 (Day 169, 6 months after vaccination) and will receive phone calls at 7 days after vaccination for safety check.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UB-612 100 μg, 0.5 mL | Experimental | Biological: UB-612All subjects will be enrolled to receive one dose of 100 μg UB-612 vaccine |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy male or non-pregnant female between the age of 20 and 55 years at time of enrolment.
- Fully vaccinated with two injections of AstraZeneca COVID-19 vaccine (ChAdOx1-S) with an 8-16 week interval between first and second doses. The second dose of AstraZeneca COVID-19 vaccine (ChAdOx1-S) must have been administered more than six (6) months from study Day 1. The CDC COVID-19 Vaccination Record Card or appropriate documentation (e.g., medical records) will be required for documentation.
- Women of childbearing potential and men must agree to practice medically effective contraception from vaccination until 30 days after the vaccination.
- Participant or the participant's legal representative must understand the procedures of the study and is willing to sign the Informed Consent Form (ICF).
- Able to understand and agrees to comply with all study procedures and be available for all study visits.
Key exclusion criteria (21 listed)
- History of anaphylaxis, urticarial, or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
- Female who is pregnant or positive in pregnancy test at screening or just prior to vaccination administration or plans to become pregnant from the time of study vaccination through 30 days after the administration of the study vaccine.
- Female who is breast-feeding or plans to breastfeed from the time of the study vaccination through 30 days after the administration of the study vaccine.
- Investigational non-coronavirus vaccines: previous receipt of an investigational vaccine (non-coronavirus) within 1 year before the planned administration of study vaccine.
- Prior administration of attenuated, nucleic acid (mRNA or DNA) or vectored vaccines in last 1 month before the study vaccine or expectation of such vaccines in the month after the study vaccine.
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-612UB-612 includes a designer S1-RBD-sFc fusion protein formulated with designer Th and CTL epitope peptides selected from immunodominant M, S2 and N regions known to bind to human MHC I and II. | Biological | UB-612 100 μg, 0.5 mL |
Primary outcome
Safety and tolerability
Time frame: within 7 days after vaccination
* Local solicited adverse events * Systemic solicited adverse events * Skin allergic reactions
Safety and tolerability
Time frame: 28 days after vaccination
• Unsolicited adverse events
Immunogenicity
Time frame: 14 days after vaccination
• Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild type
Immunogenicity
Time frame: 14 days after vaccination
• Seroconversion rate (SCR) of neutralizing antibody against SARS-CoV-2 wild type
Immunogenicity
Time frame: 14 days after vaccination
• Geometric mean fold increase (GMFI) of neutralizing antibody against SARS-CoV-2 wild type
24 secondary outcomes
Safety
Time frame: Day 1
Safety
Time frame: 14 days after vaccination
Safety
Time frame: 28 days after vaccination
Safety
Time frame: 6 months after vaccination
Evaluation of safety of hematology and biochemistry
Time frame: Pre-vaccination
Immunogenicity
Time frame: 14 days after vaccination
Immunogenicity
Time frame: 14 days after vaccination
Immunogenicity
Time frame: 14 days after vaccination
Immunogenicity
Time frame: 28 days after vaccination
Immunogenicity
Time frame: 28 days after vaccination
Immunogenicity
Time frame: 28 days after vaccination
Immunogenicity
Time frame: 6 months after vaccination
Immunogenicity
Time frame: 6 months after vaccination
Immunogenicity
Time frame: 6 months after vaccination
Immunogenicity
Time frame: 14 days after vaccination
Immunogenicity
Time frame: 14 days after vaccination
Immunogenicity
Time frame: 14 days after vaccination
Immunogenicity
Time frame: 14 days after vaccination
Immunogenicity
Time frame: 28 days after vaccination
Immunogenicity
Time frame: 28 days after vaccination
Immunogenicity
Time frame: 28 days after vaccination
Immunogenicity
Time frame: 28 days after vaccination
Immunogenicity
Time frame: Day 1
Immunogenicity
Time frame: 14 days after vaccination
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 26 Aug 2022.
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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.
Chang-Yi Wang, Ph.D. study chair
United Biomedical Inc., Asia
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UB-612 in people with COVID-19, run by United Biomedical Inc., Asia.
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 11 inclusion and 21 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 26 Aug 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety and tolerability (time frame: within 7 days after vaccination). 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 26 Aug 2022.