AzTrials
AzTrials

COVID-19Phase 1NCT04545749

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine

A Phase 1 study testing UB-612 in people with COVID-19, run by United Biomedical Inc., Asia at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a phase I, open-label, dose-escalation clinical study to evaluate the safety, tolerability and immunogenicity of 3 ascending doses of UB-612 COVID-19 vaccine in healthy adults, aged from 20 to 55 years old. 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
60 participants
Where
1 siteTaiwan
Study dates
25 Sep 2020to 24 May 2021
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 enrollment.
  • Women of childbearing potential and men must agree to practice medically effective contraception from first vaccination until 3 months after the last vaccination.
  • Able to understand the content and possible risks of informed consent and 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.
  • Negative serological test for Hepatitis B surface antigen (HBsAg), HCV RNA and HIV antibody screening.
  • Negative in serum antibodies (IgG) against SARS-CoV-2 ELISA.
Show all 11Show fewer
  • Negative result of RT-PCR screening of nasopharyngeal or throat swabs for SARS-CoV-2.
  • Ear temperature ≤ 38.0°C.
  • The body mass index (BMI) of 18-30 kg/m2, inclusive, at screening.
  • Indexes of blood routine, biochemistry and other laboratory tests are within the normal ranges, or not clinically significant as judged by investigators.
  • Judged to be healthy by the investigator on the basis of medical history, physical examination, 12-lead ECG, vital signs, and clinical laboratory tests performed at screening.

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 each vaccination administration.
  • Female who is breast-feeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination.
  • Any acute illness, as determined by the study investigator 3 days before first vaccination.
  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • Known history of SARS or MERS.
Show all 20Show fewer
  • Previous exposure to SARS-CoV-2 or receipt of an investigational vaccine product for the prevention of COVID-19, MERS or SARS.
  • Subjects who take part in another clinical study within 12 weeks prior to the day of informed consent.
  • With certain underlying medical conditions which are at increased risk for severe illness from COVID-19.
  • Congenital or acquired angioedema.
  • Immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease or immunosuppressive therapy.
  • Platelet disorder or other bleeding disorder may cause injection contraindication.
  • Prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before first vaccination.
  • Prior administration of immunoglobulins and/or any blood products in last 4 months before first vaccination.
  • Prior administration of attenuated, nucleic acid (mRNA or DNA) or vectored vaccines in last 1 month before first vaccination or expectation of such vaccines in the month after the second vaccination.
  • Prior administration of subunit vaccine or inactivated vaccine in last 14 days before first vaccination or expectation of receipt of such vaccines in the 14 days after the second vaccination.
  • Current anti-tuberculosis (TB) therapy or history of TB.
  • Alcoholism or substance abuser.
  • History of malignancy within 5 years prior to screening visit, except basal cell carcinoma of the skin and cervical carcinoma in situ.
  • Any medical disease or condition that, in the opinion of the study investigator, may confound the results of the study or pose an additional risk to the subjects by their participation in the study.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • China Medical University Hospital

    Taichung, 404

Other trials in Taiwan

About this study

Official title: A Phase I, Open-label Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 Vaccine in Healthy Adult Volunteers

This is a phase I, open-label, dose-escalation clinical study to evaluate the safety, tolerability and immunogenicity of 3 ascending doses of UB-612 COVID-19 vaccine in healthy adults, aged from 20 to 55 years old.

Read the detailed description

This is a phase I, open-label, dose-escalation clinical study to evaluate the safety, tolerability and immunogenicity of 3 ascending doses of UB-612 COVID-19 vaccine in healthy adults. Up to 60 subjects (20 subjects per group) will be enrolled into this study. Subjects in each group will be enrolled to receive two doses of UB-612 vaccine at 28-day interval (Day 0 and Day 28).

Conditions
COVID-19
Being tested
UB-612
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 is a proprietary high-precision designer S1-RBD-protein based vaccine incorporating a Th/CTL epitope peptide pool which could bind to human MHC-I and MHC-II to activate T cells.

Study groups in NCT04545749
Study groupRoleWhat they receive
Group A (Low dose)Experimental20 subjects will be enrolled to receive low dose of UB-612 vaccine.
Receives: Biological: UB-612
Group B (Medium dose)Experimental20 subjects will be enrolled to receive medium dose of UB-612 vaccine.
Receives: Biological: UB-612
Group C (High dose)Experimental20 subjects will be enrolled to receive high dose of UB-612 vaccine.
Receives: Biological: UB-612

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of UB-612 vaccine

    1. Occurrence of adverse reactions within 7 days after vaccination
    2. Percentage of subjects with ≥ Grade 3 adverse events within 7 days after vaccination

    Measured: 7 days following vaccination

Secondary outcomes (6)

  1. Safety

    1. Occurrence of adverse events (AEs) till Day 56
    2. Occurrence of serious adverse events (SAEs) till Day 56

    Measured: Day 0 to Day 56

  2. Safety

    Occurrence of serious adverse events during the whole follow-up period

    Measured: Day 29 to Day 196

  3. Safety

    Occurrence of adverse events of special interest during the study period

    Measured: Day 0 to Day 196

  4. Immunogenicity

    Geometric mean titer (GMT) of antigen-specific antibody (Anti-S1-RBD)

    Measured: Day 14, 28, 42, 56, 112, and 196

  5. Immunogenicity

    Seroconversion rate (SCR) of antigen-specific antibody (Anti-S1-RBD)

    Measured: Day 14, 28, 42, 56, 112, and 196

  6. Immunogenicity

    Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)

    Measured: Day 14, 28, 42, 56, 112, and 196

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2020
  2. Study start25 Sep 2020
  3. Primary completion18 Jan 2021
  4. Study completion24 May 2021

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04545749
Sponsor's protocol ID
V-122
Status last verified
Feb 2022
First submitted
2 Sep 2020
Last updated
26 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang CY, Hwang KP, Kuo HK, Peng WJ, Shen YH, Kuo BS, Huang JH, Liu H, Ho YH, Lin F, Ding S, Liu Z, Wu HT, Huang CT, Lee YJ, Liu MC, Yang YC, Lu PL, Tsai HC, Lee CH, Shi ZY, Liu CE, Liao CH, Chang FY, Chen HC, Wang FD, Hou KL, Cheng J, Wang MS, Yang YT, Chiu HC, Jiang MH, Shih HY, Shen HY, Chang PY, Lan YR, Chen CT, Lin YL, Liang JJ, Liao CC, Chou YC, Morris MK, Hanson CV, Guirakhoo F, Hellerstein M, Yu HJ, King CC, Kemp T, Heppner DG, Monath TP. A multitope SARS-CoV-2 vaccine provides long-lasting B cell and T cell immunity against Delta and Omicron variants. J Clin Invest. 2022 May 16;132(10):e157707. doi: 10.1172/JCI157707.

    PubMed 35316221

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 at 1 site in Taiwan.

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 20 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: finished, 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.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 of UB-612 vaccine (time frame: 7 days following vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04545749, which also lists 1 linked publication.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in