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COVID-19Phase 1NCT04967742

A Extension 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
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Trial summary

This is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612 vaccine 10, 30, and 100 μg in V-122 study. 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
50 participants
Where
1 siteTaiwan
Study dates
5 Aug 2021to 31 Oct 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

  • Male or non-pregnant female who previously participated in and completed two vaccinations in the V-122 Study.
  • Women of childbearing potential and men must agree to practice medically effective contraception during study period.
  • 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.
  • Ear temperature ≤ 38.0°C.
  • At screening visit, at least 6 months after first vaccination in the V-122 study.

Who cannot join

  • Female who is pregnant or positive in pregnancy test at screening visit.
  • Female who is breast-feeding or plans to breastfeed within 90 days after booster vaccination.
  • Any acute illness, as determined by the study investigator 3 days before booster vaccination.
  • Prior administration of attenuated, nucleic acid (mRNA or DNA) or vectored vaccines in last 1 month before booster vaccination or expectation of such vaccines in the month after booster vaccination.
  • Prior administration of subunit vaccine or inactivated vaccine in last 14 days before booster vaccination or expectation of receipt of such vaccines in the 14 days after booster vaccination.
  • 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.
Show all 10Show fewer
  • Previous exposure to SARS-CoV-2 or receipt of an investigational or EUA vaccine product for the prevention of COVID-19, MERS or SARS except UB-612.
  • Subjects who take part in another clinical study, other than V-122 study, within 12 weeks prior to the day of informed consent.
  • Prior administration of immunoglobulins and/or any blood products in last 4 months before booster vaccination.
  • Prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before first vaccination.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • China Medical University Hospital

    Taichung

Other trials in Taiwan

About this study

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

This is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612 vaccine 10, 30, and 100 μg in V-122 study.

Read the detailed description

This is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612 vaccine 10, 30, and 100 μg in V-122 study. 60 subjects will receive one booster dose of UB-612 vaccines 100 μg with the same dose which was offered in Phase II study, at least 6 months after first vaccination. In this study, there will be 3 clinical visits. Subjects will come to the clinics at Day 1, Day 15, and Day 85.

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 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 groups in NCT04967742
Study groupRoleWhat they receive
A group: 1 booster dose of UB-612 vaccine 100 μgExperimental1 booster dose for subjects at UB-612 vaccine 10 μg in V-122 study.
Receives: Biological: UB-612
B group: 1 booster dose of UB-612 vaccine 100 μgExperimental1 booster dose for subjects at UB-612 vaccine 30 μg in V-122 study.
Receives: Biological: UB-612
C group: 1 booster dose of UB-612 vaccine 100 μgExperimental1 booster dose for subjects at UB-612 vaccine 100 μg in V-122 study.
Receives: Biological: UB-612

What is being measured

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

  1. GMT of neutralizing antibody against SARS-CoV-2

    Evaluation of Immunogenicity

    Measured: Day 1

  2. GMT of neutralizing antibody against SARS-CoV-2

    Evaluation of Immunogenicity

    Measured: Day 15

  3. GMT of neutralizing antibody against SARS-CoV-2

    Evaluation of Immunogenicity

    Measured: Day 85

  4. Geometric mean fold increase of neutralizing antibody against SARS-CoV-2

    Evaluation of Immunogenicity

    Measured: Day 15

  5. Geometric mean fold increase of neutralizing antibody against SARS-CoV-2

    Evaluation of Immunogenicity

    Measured: Day 85

  6. Occurrence of adverse reactions and the percentage of subjects with ≥ Grade 3 adverse events

    Evaluation of Safety

    Measured: Within 7 days after vaccination

Secondary outcomes (7)

  1. GMT of antigen-specific antibody (Anti-S1-RBD)

    Evaluation of Immunogenicity

    Measured: Day 1

  2. GMT of antigen-specific antibody (Anti-S1-RBD)

    Evaluation of Immunogenicity

    Measured: Day 15

  3. GMT of antigen-specific antibody (Anti-S1-RBD)

    Evaluation of Immunogenicity

    Measured: Day 85

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

    Evaluation of Immunogenicity

    Measured: Day 15

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

    Evaluation of Immunogenicity

    Measured: Day 85

  6. Correlation between the immune response detected by ELISA and live virus neutralization test

    Evaluation of Immunogenicity

    Measured: During the study period

  7. Occurrence of SAEs, AESIs, MAAEs and SAEs

    Evaluation of Safety

    Measured: During the study period

Timeline

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

  1. First posted20 Jul 2021
  2. Study start5 Aug 2021
  3. Primary completion22 Aug 2021
  4. Study completion31 Oct 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
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04967742
Sponsor's protocol ID
V-123
Status last verified
Feb 2022
First submitted
12 Jul 2021
Last updated
26 Aug 2022
Results posted
No
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 6 inclusion and 10 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?

GMT of neutralizing antibody against SARS-CoV-2 (time frame: Day 1). The study lists 6 primary outcomes in all. 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 NCT04967742, 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.

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