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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 : Terminated (Under the limited resources, to re-plan the ongoing clinical trials of this product.)
First Posted : February 26, 2021
Last Update Posted : August 26, 2022
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 August 26, 2022
Actual Study Start Date  ICMJE January 30, 2021
Actual Primary Completion Date March 8, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2022)
  • Geometric mean titer (GMT) of SARS-CoV-2 neutralizaing antibody [ Time Frame: Day 57 ]
    Immunogenicity evaluation
  • Seroconversion rate (SCR) of SARS-CoV-2 neutralizing antibody [ Time Frame: Day 57 ]
    Immunogenicity evaluation
  • Local reactions and systemic events [ Time Frame: Up to 7 days following each dose ]
    Safety evaluation
  • Unsolicited adverse events [ Time Frame: Day 1 to Day 57 ]
    Safety evaluation
  • Medically attend adverse events (MAAEs), serious adverse events (SAEs), adverse event of special interests (AESIs) and antibody dependent enhancements (ADEs) [ Time Frame: Day 1 to Day 365 ]
    Safety evaluation
Original 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2022)
  • SCR of anti-S1-RBD antibody [ Time Frame: Day 57 ]
    Immunogenicity evaluation
  • GMT of SARS-CoV-2 neutralizing antibody [ Time Frame: Day 197 and 365 ]
    Immunogenicity evaluation
  • GMT of anti-S1-RBD antibody [ Time Frame: Day 57, 197 and 365 ]
    Immunogenicity evaluation
  • Geometric mean fold increase in SARS-CoV-2 neutralizing antibody and antigen-specific antibody (Anti-S1-RBD) [ Time Frame: Day 57, 197 and 365 ]
    Immunogenicity evaluation
  • Lot consistency by comparisons of GMT of SARS-CoV-2 neutralizing antibody [ Time Frame: Day 57 ]
    Evaluation of lot to lot consistency
Original 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
Current Other Pre-specified Outcome Measures
 (submitted: March 7, 2022)
  • Antigen-specific interferon-gamma (IFN-γ) and IL-4 production measured by ELISpot [ Time Frame: Day 57 and 14 days post 3rd dose ]
    Evaluation of T cell function induced by UB-612
  • CD4+ and CD8+ T cell responses measured by flow cytometric assays [ Time Frame: Day 57 and 14 days post 3rd dose ]
    Evaluation of T cell function induced by UB-612
  • GMT of SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days post 3rd dose ]
    Immunogenicity evaluation
  • GMT of anti-S1-RBD antibody [ Time Frame: 14 days post 3rd dose ]
    Immunogenicity evaluation
  • Geometric mean fold increase in SARS-CoV-2 neutralizing antibody and anti-S1-RBD antibody [ Time Frame: 14 days post 3rd dose ]
    Immunogenicity evaluation
  • GMT of SARS-CoV-2 neutralizing antibody and anti-S1-RBD antibody in adolescents [ Time Frame: Day 57, Day 197 and Day 365 ]
    Immunogenicity evaluation
  • SCR of SARS-CoV-2 neutralizing antibody and anti-S1-RBD antibody in adolescents [ Time Frame: Day 57 ]
    Immunogenicity evaluation
  • Geometric mean fold increase in SARS-CoV-2 neutralizing antibody and anti-S1-RBD antibody in adolescents [ Time Frame: Day 57, Day 197, and Day 365 ]
    Immunogenicity evaluation
  • 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
  • Antibody against SARS-CoV-2 antigens measured by ELISA [ Time Frame: Day 1 to Day 365 ]
    Antigens derived from S2, N and M protein.
Original 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
 
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. 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.
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.
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 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.
  • Biological: Placebo
    Around 550 adult subjects and 55 adolescent subjects will receive 2 doses of normal saline 0.9%.
Study Arms  ICMJE
  • Experimental: UB-612
    A proprietary high-precision designer S1-RBD protein based vaccine incorporating Th/CTL peptides to activate T cells.
    Intervention: Biological: UB-612
  • Placebo Comparator: Placebo
    Normal saline 0.9%.
    Intervention: Biological: Placebo
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.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: March 7, 2022)
3877
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2021)
3850
Actual Study Completion Date  ICMJE March 8, 2022
Actual Primary Completion Date March 8, 2022   (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) who 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 information is only displayed when the study is recruiting subjects
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 Yes
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
Current Responsible Party United Biomedical Inc., Asia
Original Responsible Party Same as current
Current Study Sponsor  ICMJE United Biomedical Inc., Asia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Vaxxinity, Inc.
Investigators  ICMJE
Study Chair: Chang-Yi Wang, Ph.D. United Biomedical Inc., Asia
PRS Account United Biomedical Inc., Asia
Verification Date June 2022

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