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

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ClinicalTrials.gov Identifier: NCT04773067
Recruitment Status : Recruiting
First Posted : February 26, 2021
Last Update Posted : September 29, 2021
Sponsor:
Collaborator:
Vaxxinity, Inc.
Information provided by (Responsible Party):
United Biomedical Inc., Asia

Tracking Information
First Submitted Date  ICMJE February 23, 2021
First Posted Date  ICMJE February 26, 2021
Last Update Posted Date September 29, 2021
Actual Study Start Date  ICMJE January 30, 2021
Actual Primary Completion Date June 27, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2021)
  • Geometric mean titer (GMT) of SARS-CoV-2 neutralizaing antibody [ Time Frame: Day 57 ]
    Evaluation of immunogenicity
  • Seroconversion rate (SCR) of SARS-CoV-2 neutralizing antibody [ Time Frame: Day 57 ]
    Evaluation of immunogenicity
  • Safety evaluation [ Time Frame: Day 1 to Day 197 ]
    1. Local reactions and systemic events for up to 7 days following each dose
    2. Unsolicited adverse events from Day 1 to Day 57
    3. MAAEs, SAEs, AESIs and ADEs from Day 1 to Day 197
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2021)
  • SCR of anti-S1-RBD antibody [ Time Frame: Day 57 ]
    Evaluation of immunogenicity
  • GMT of SARS-CoV-2 neutralizing antibody [ Time Frame: Day 197 and 365 ]
    Evaluation of immunogenicity
  • GMT of anti-S1-RBD antibody [ Time Frame: Day 57, 197 and 365 ]
    Evaluation of immunogenicity
  • Geometric mean fold increase in anti-S1-RBD and SARS-CoV-2 neutralizing antibodies [ Time Frame: Day 57, 197 and 365 ]
    Evaluation of immunogenicity
  • Evaluation of lot to lot consistency [ Time Frame: Day 57 ]
    As assessed by the comparisons of the GMT of SARS-CoV-2 neutralizing antibody induced by 3 independent clinical materials
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 24, 2021)
  • GMT of SARS-CoV-2 neutralizing antibody in adolescents [ Time Frame: Day 57 ]
    Evaluation of immunogenicity
  • SCR of SARS-CoV-2 neutralizing antibody in adolescents [ Time Frame: Day 57 ]
    Evaluation of immunogenicity
  • Safety evaluation in adolescents [ Time Frame: Day 1 to Day 365 ]
    1. Local reactions and systemic events for up to 7 days following each dose
    2. Unsolicited AEs from Day 1 to Day 57
    3. MAAEs, SAEs, AESIs and ADEs from Day 1 to Day 365
  • Incidence of COVID-19 cases [ Time Frame: Day 1 to Day 365 ]
    COVID-19 incidence per 1000 person-years of follow-up
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: UB-612
    Around 3850 adult subjects will be enrolled into core group, and 385 adolescents will be recruited for supplementary group.
  • Biological: Placebo
    Around 3850 adult subjects will be enrolled into core group, and 385 adolescents will be recruited for supplementary group.
Study Arms  ICMJE
  • Experimental: UB-612
    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.
    Intervention: Biological: UB-612
  • Placebo Comparator: Placebo
    0.9% sodium chloride
    Intervention: Biological: Placebo
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 24, 2021)
3850
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Actual Primary Completion Date June 27, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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) directly involved in the conduct of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 85 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Hope Liu, Ph.D. +886-3-657-8861 ext 5837 hope.liu@ubiasia.com.tw
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04773067
Other Study ID Numbers  ICMJE V-205
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 September 2021

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