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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 : October 28, 2021
Sponsor:
Collaborator:
Vaxxinity, Inc.
Information provided by (Responsible Party):
United Biomedical Inc., Asia

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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: UB-612 Biological: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : January 30, 2021
Actual Primary Completion Date : June 27, 2021
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
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.
Biological: UB-612
Around 3850 adult subjects will be enrolled into core group, and 385 adolescents will be recruited for supplementary group.

Placebo Comparator: Placebo
0.9% sodium chloride
Biological: Placebo
Around 3850 adult subjects will be enrolled into core group, and 385 adolescents will be recruited for supplementary group.




Primary Outcome Measures :
  1. Geometric mean titer (GMT) of SARS-CoV-2 neutralizaing antibody [ Time Frame: Day 57 ]
    Evaluation of immunogenicity

  2. Seroconversion rate (SCR) of SARS-CoV-2 neutralizing antibody [ Time Frame: Day 57 ]
    Evaluation of immunogenicity

  3. 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

  4. Safety evaluation [ Time Frame: Day 1 to Day 365 ]
    MAAEs, SAEs, AESIs and ADEs from Day 1 to Day 365


Secondary Outcome Measures :
  1. SCR of anti-S1-RBD antibody [ Time Frame: Day 57 ]
    Evaluation of immunogenicity

  2. GMT of SARS-CoV-2 neutralizing antibody [ Time Frame: Day 197 and 365 ]
    Evaluation of immunogenicity

  3. GMT of anti-S1-RBD antibody [ Time Frame: Day 57, 197 and 365 ]
    Evaluation of immunogenicity

  4. Geometric mean fold increase in SARS-CoV-2 neutralizing antibody and antigen-specific antibody (Anti-S1-RBD) [ Time Frame: Day 57, 197 and 365 ]
    Evaluation of immunogenicity

  5. 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


Other Outcome Measures:
  1. T cell responses to UB-612 measured by ELISpot and flow cytometric assays [ Time Frame: Day 57 and 14 days post 3rd dose ]
    Evaluation of T cell function induced by UB-612 vaccine

  2. GMT of SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days post 3rd dose ]
    Evaluation of immunogenicity

  3. GMT of antigen-specific antibody (Anti-S1-RBD) [ Time Frame: 14 days post 3rd dose ]
    Evaluation of immunogenicity

  4. Geometric mean fold increase in SARS-CoV-2 neutralizing antibody and antigen-specific antibody (Anti-S1-RBD) [ Time Frame: 14 days post 3rd dose ]
    Evaluation of immunogenicity

  5. GMT of SARS-CoV-2 neutralizing antibody and antigen-specific antibody (Anti-S1-RBD) in adolescents [ Time Frame: Day 57, Day 197 and Day 365 ]
    Evaluation of immunogenicity

  6. SCR of SARS-CoV-2 neutralizing antibody in adolescents [ Time Frame: Day 57 ]
    Evaluation of immunogenicity

  7. Geometric mean fold increase in SARS-CoV-2 neutralizing antibody and antigen-specific antibody (Anti-S1-RBD) in adolescents [ Time Frame: Day 57, Day 197, and Day 365 ]
    Evaluation of immunogenicity

  8. 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

  9. Incidence of COVID-19 cases [ Time Frame: Day 1 to Day 365 ]
    COVID-19 incidence per 1000 person-years of follow-up

  10. To detect antibody against SARS-CoV-2 antigens derived from S2, N, and M protein [ Time Frame: Day 1 to Day 365 ]
    Evaluation of antibody against SARS-CoV-2 antigens



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04773067


Contacts
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Contact: Hope Liu, Ph.D. +886-3-657-8861 ext 5837 hope.liu@ubiasia.com.tw

Locations
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Taiwan
Changhua Christian Hospital Recruiting
Changhua, Taiwan
Contact: Chun-Eng Liu, M.D., Ph.D.         
Principal Investigator: Chun-Eng Liu, M.D., Ph.D.         
Chang-Geng Medical Foundation Kaoshiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan
Contact: Chen-Hsiang Lee, M.D.,M.S.         
Principal Investigator: Chen-Hsiang Lee, M.D.,M.S.         
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan
Contact: Po-Liang Lu, M.D., Ph.D.         
Principal Investigator: Po-Liang Lu, M.D., Ph.D.         
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan
Contact: Hung-Chin Tsai, M.D., Ph.D.         
Principal Investigator: Hung-Chin Tsai, M.D., Ph.D.         
Far Eastern Memorial Hospital Recruiting
New Taipei City, Taiwan
Contact: Chun-Hsing Liao, M.D.         
Principal Investigator: Chun-Hsing Liao, M.D.         
China Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Kao-Pin Hwang, M.D., Ph.D.         
Principal Investigator: Kao-Pin Hwang, M.D., Ph.D.         
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan
Contact: Zhi-Yuan Shi, M.D.         
Principal Investigator: Zhi-Yuan Shi, M.D.         
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan
Contact: Yi-Ching Yang, M.D., M.P.H.         
Principal Investigator: Yi-Ching Yang, M.D., M.P.H.         
Taipei Medical University Hospital Recruiting
Taipei, Taiwan
Contact: Yuam-Jang Lee, M.D.         
Principal Investigator: Yuam-Jang Lee, M.D.         
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan
Contact: Fu-Der Wang, M.D.         
Principal Investigator: Fu-Der Wang, M.D.         
Tri-Service General Hospital Recruiting
Taipei, Taiwan
Contact: Feng-Yee Chang, M.D., Ph.D.         
Principal Investigator: Feng-Yee Chang, M.D., Ph.D.         
Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital Recruiting
Taoyuan, Taiwan
Contact: Ching-Tai Huang, M.D., Ph.D.         
Principal Investigator: Ching-Tai Huang, M.D., Ph.D.         
Sponsors and Collaborators
United Biomedical Inc., Asia
Vaxxinity, Inc.
Investigators
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Study Chair: Chang-Yi Wang, Ph.D. United Biomedical
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Responsible Party: United Biomedical Inc., Asia
ClinicalTrials.gov Identifier: NCT04773067    
Other Study ID Numbers: V-205
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases