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COVID-19Phase 2NCT04773067

A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers

A Phase 2 study testing UB-612 in people with COVID-19, run by United Biomedical Inc., Asia at 12 sites in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a phase II, observer-blind, multiple-centre, randomized, placebo-controlled study to evaluate the immunogenicity, safety, tolerability and lot consistency of 2 doses of UB-612 vaccine in adolescent, younger and elderly adults. Read more about this study

Who is it for?
Ages 12 to 85 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?
Yes, some participants may receive a placebo
How many people
3,877 participants
Where
12 sitesTaiwan
Study dates
30 Jan 2021to 8 Mar 2022
Phase
Phase 2
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 12 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Healthy male or non-pregnant female between the age of 12 to 85 years at time of enrolment.
  • 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.
  • Ear temperature ≤ 38.0°C.
  • Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. In the investigator's clinical judgement, participant may have a stable and well-controlled comorbidity associated with an increased risk of progression to severe COVID-19.

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 (these subjects can be re-scheduled).
  • Any major surgery one month before first vaccination (these subjects can be -rescheduled).
  • Known HIV antibody positive.
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  • Known active hepatitis B and hepatitis C disease.
  • Previous exposure to SARS-CoV-2 or receipt of an investigational or licensed product for the prevention of COVID-19, MERS or SARS.
  • Have history of Guillain-Barre syndrome.
  • Subjects who take part in another clinical study within 12 weeks prior to the day of informed consent.
  • Immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease or immunosuppressive therapy.
  • Subjects who plan to or are undergoing anti-cancer 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.
  • Receipt of any seasonal or pandemic influenza vaccine within 14 days, or any other non-study vaccine within 28 days, before study intervention administration.
  • Anticipated receipt of any seasonal or pandemic influenza vaccine within 14 days, or any other nonstudy vaccine within 28 days, after study intervention administration.
  • Receipt of short-term (<14 days) 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.
  • 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.
  • 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.
  • Employees at the investigator's site, of the Sponsor or the contract research organization (CRO) who directly involved in the conduct of the study.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Taiwan12 sites

  • Changhua Christian Hospital

    Changhua

  • Chang-Geng Medical Foundation Kaoshiung Chang Gung Memorial Hospital

    Kaohsiung City

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • Kaohsiung Veterans General Hospital

    Kaohsiung City

  • Far Eastern Memorial Hospital

    New Taipei City

  • China Medical University Hospital

    Taichung

  • Taichung Veterans General Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan

  • Taipei Medical University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Tri-Service General Hospital

    Taipei

  • Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital

    Taoyuan

Other trials in Taiwan

About this study

Official title: A Phase II, Placebo-controlled, Randomized, Observer-blind Study to Evaluate the Immunogenicity, Safety, and Tolerability of UB-612 Vaccine Against COVID-19 in Adolescent, Younger and Elderly Adult Volunteers

This is a phase II, observer-blind, multiple-centre, randomized, placebo-controlled study to evaluate the immunogenicity, safety, tolerability and lot consistency of 2 doses of UB-612 vaccine in adolescent, younger and elderly adults. Around 3850 adult subjects will be randomized to be composed of the core group, while around 385 adolescents will be randomized to be the supplementary group. Subjects will be unblinded at Visit 5, and subjects in the vaccine group will be encouraged to have 3rd dose of vaccination.

Read the detailed description

This clinical study will be consisted of 7 clinical visits and one long-term follow-up visit. Subjects will also be unblinded at Visit 5, subjects in placebo group will withdraw from the study and subjects in vaccine group will be encouraged to have 3rd dose of vaccination (Day 197~Day 242) at Visit 6. Those who received 3rd dose will have Visit 7 (14 days after Visit 6) to check the booster effect. After Day 197, subjects will enter the long-term follow-up with a safety call bi-monthly.

Conditions
COVID-19
Being tested
UB-612, Placebo
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

    Around 3300 adult subjects and 330 adolescent subjects will receive 2 doses of 100 µg UB-612 vaccine. The subjects will be invited to have the 3rd dose after unblinded.

  • PlaceboBiological

    Around 550 adult subjects and 55 adolescent subjects will receive 2 doses of normal saline 0.9%.

Study groups in NCT04773067
Study groupRoleWhat they receive
UB-612ExperimentalA proprietary high-precision designer S1-RBD protein based vaccine incorporating Th/CTL peptides to activate T cells.
Receives: Biological: UB-612
PlaceboPlacebo comparatorNormal saline 0.9%.
Receives: Biological: Placebo

What is being measured

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

  1. Geometric mean titer (GMT) of SARS-CoV-2 neutralizaing antibody

    Immunogenicity evaluation

    Measured: Day 57

  2. Seroconversion rate (SCR) of SARS-CoV-2 neutralizing antibody

    Immunogenicity evaluation

    Measured: Day 57

  3. Local reactions and systemic events

    Safety evaluation

    Measured: Up to 7 days following each dose

  4. Unsolicited adverse events

    Safety evaluation

    Measured: Day 1 to Day 57

  5. Medically attend adverse events (MAAEs), serious adverse events (SAEs), adverse event of special interests (AESIs) and antibody dependent enhancements (ADEs)

    Safety evaluation

    Measured: Day 1 to Day 365

Secondary outcomes (5)

  1. SCR of anti-S1-RBD antibody

    Immunogenicity evaluation

    Measured: Day 57

  2. GMT of SARS-CoV-2 neutralizing antibody

    Immunogenicity evaluation

    Measured: Day 197 and 365

  3. GMT of anti-S1-RBD antibody

    Immunogenicity evaluation

    Measured: Day 57, 197 and 365

  4. Geometric mean fold increase in SARS-CoV-2 neutralizing antibody and antigen-specific antibody (Anti-S1-RBD)

    Immunogenicity evaluation

    Measured: Day 57, 197 and 365

  5. Lot consistency by comparisons of GMT of SARS-CoV-2 neutralizing antibody

    Evaluation of lot to lot consistency

    Measured: Day 57

Timeline

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

  1. First posted26 Feb 2021
  2. Study start30 Jan 2021
  3. Primary completion8 Mar 2022
  4. Study completion8 Mar 2022

Why it stopped: Under the limited resources, to re-plan the ongoing clinical trials of this product.

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3,877 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04773067
Sponsor's protocol ID
V-205
Status last verified
Jun 2022
First submitted
23 Feb 2021
Last updated
26 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang CY, Peng WJ, Kuo BS, Ho YH, Wang MS, Yang YT, Chang PY, Shen YH, Hwang KP. Toward a pan-SARS-CoV-2 vaccine targeting conserved epitopes on spike and non-spike proteins for potent, broad and durable immune responses. PLoS Pathog. 2023 Apr 20;19(4):e1010870. doi: 10.1371/journal.ppat.1010870. eCollection 2023 Apr.

    PubMed 37079651

  • 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 2 study testing UB-612 in people with COVID-19, run by United Biomedical Inc., Asia at 12 sites 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 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: stopped early, 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 12 sites 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. 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 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.

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 stopped early (reason given: Under the limited resources, to re-plan the ongoing clinical trials of this product.). Results are not available in the source record.

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?

Geometric mean titer (GMT) of SARS-CoV-2 neutralizaing antibody (time frame: Day 57). 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?

On the ClinicalTrials.gov record for NCT04773067, which also lists 2 linked publications.

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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