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Trial record 1 of 1 for:    NCT04545749
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A Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04545749
Recruitment Status : Completed
First Posted : September 11, 2020
Last Update Posted : June 7, 2021
Sponsor:
Collaborator:
Vaxxinity, Inc.
Information provided by (Responsible Party):
United Biomedical Inc., Asia

Tracking Information
First Submitted Date  ICMJE September 2, 2020
First Posted Date  ICMJE September 11, 2020
Last Update Posted Date June 7, 2021
Actual Study Start Date  ICMJE September 25, 2020
Actual Primary Completion Date January 18, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2020)
Safety of UB-612 vaccine [ Time Frame: 7 days following vaccination ]
  1. Occurrence of adverse reactions within 7 days after vaccination
  2. Percentage of subjects with ≥ Grade 3 adverse events within 7 days after vaccination
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2020)
  • Safety [ Time Frame: Day 0 to Day 56 ]
    1. Occurrence of adverse events (AEs) till Day 56
    2. Occurrence of serious adverse events (SAEs) till Day 56
  • Safety [ Time Frame: Day 29 to Day 196 ]
    Occurrence of serious adverse events during the whole follow-up period
  • Safety [ Time Frame: Day 0 to Day 196 ]
    Occurrence of adverse events of special interest during the study period
  • Immunogenicity [ Time Frame: Day 14, 28, 42, 56, 112, and 196 ]
    Geometric mean titer (GMT) of antigen-specific antibody (Anti-S1-RBD)
  • Immunogenicity [ Time Frame: Day 14, 28, 42, 56, 112, and 196 ]
    Seroconversion rate (SCR) of antigen-specific antibody (Anti-S1-RBD)
  • Immunogenicity [ Time Frame: Day 14, 28, 42, 56, 112, and 196 ]
    Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine
Official Title  ICMJE A Phase I, Open-label Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 Vaccine in Healthy Adult Volunteers
Brief 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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE Biological: UB-612
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 Arms  ICMJE
  • Experimental: Group A (Low dose)
    20 subjects will be enrolled to receive low dose of UB-612 vaccine.
    Intervention: Biological: UB-612
  • Experimental: Group B (Medium dose)
    20 subjects will be enrolled to receive medium dose of UB-612 vaccine.
    Intervention: Biological: UB-612
  • Experimental: Group C (High dose)
    20 subjects will be enrolled to receive high dose of UB-612 vaccine.
    Intervention: Biological: UB-612
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 24, 2021
Actual Primary Completion Date January 18, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy male or non-pregnant female between the age of 20 and 55 years at time of enrollment.
  2. Women of childbearing potential and men must agree to practice medically effective contraception from first vaccination until 3 months after the last vaccination.
  3. Able to understand the content and possible risks of informed consent and willing to sign the Informed Consent Form (ICF).
  4. Able to understand and agrees to comply with all study procedures and be available for all study visits.
  5. Negative serological test for Hepatitis B surface antigen (HBsAg), HCV RNA and HIV antibody screening.
  6. Negative in serum antibodies (IgG) against SARS-CoV-2 ELISA.
  7. Negative result of RT-PCR screening of nasopharyngeal or throat swabs for SARS-CoV-2.
  8. Ear temperature ≤ 38.0°C.
  9. The body mass index (BMI) of 18-30 kg/m2, inclusive, at screening.
  10. Indexes of blood routine, biochemistry and other laboratory tests are within the normal ranges, or not clinically significant as judged by investigators.
  11. 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.

Exclusion Criteria:

  1. History of anaphylaxis, urticarial, or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
  2. Female who is pregnant or positive in pregnancy test at screening or just prior to each vaccination administration.
  3. Female who is breast-feeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination.
  4. Any acute illness, as determined by the study investigator 3 days before first vaccination.
  5. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  6. Known history of SARS or MERS.
  7. Previous exposure to SARS-CoV-2 or receipt of an investigational vaccine product for the prevention of COVID-19, MERS or SARS.
  8. Subjects who take part in another clinical study within 12 weeks prior to the day of informed consent.
  9. With certain underlying medical conditions which are at increased risk for severe illness from COVID-19.
  10. Congenital or acquired angioedema.
  11. Immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease or immunosuppressive therapy.
  12. Platelet disorder or other bleeding disorder may cause injection contraindication.
  13. Prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before first vaccination.
  14. Prior administration of immunoglobulins and/or any blood products in last 4 months before first vaccination.
  15. 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.
  16. 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.
  17. Current anti-tuberculosis (TB) therapy or history of TB.
  18. Alcoholism or substance abuser.
  19. History of malignancy within 5 years prior to screening visit, except basal cell carcinoma of the skin and cervical carcinoma in situ.
  20. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04545749
Other Study ID Numbers  ICMJE V-122
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party United Biomedical Inc., Asia
Study Sponsor  ICMJE United Biomedical Inc., Asia
Collaborators  ICMJE Vaxxinity, Inc.
Investigators  ICMJE
Study Chair: Chang-Yi Wang, Ph.D. United Biomedical
PRS Account United Biomedical Inc., Asia
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP