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
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|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Biological: UB-612 Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3877 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 :||March 8, 2022|
|Actual Study Completion Date :||March 8, 2022|
A proprietary high-precision designer S1-RBD protein based vaccine incorporating Th/CTL peptides to activate T cells.
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.
Placebo Comparator: Placebo
Normal saline 0.9%.
Around 550 adult subjects and 55 adolescent subjects will receive 2 doses of normal saline 0.9%.
- 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
- 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
- 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 ]
- Local reactions and systemic events for up to 7 days following each dose
- Unsolicited AEs from Day 1 to Day 57
- 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.
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.
|Ages Eligible for Study:||12 Years to 85 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
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
|Changhua Christian Hospital|
|Chang-Geng Medical Foundation Kaoshiung Chang Gung Memorial Hospital|
|Kaohsiung Medical University Chung-Ho Memorial Hospital|
|Kaohsiung Veterans General Hospital|
|Far Eastern Memorial Hospital|
|New Taipei City, Taiwan|
|China Medical University Hospital|
|Taichung Veterans General Hospital|
|National Cheng Kung University Hospital|
|Taipei Medical University Hospital|
|Taipei Veterans General Hospital|
|Tri-Service General Hospital|
|Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital|
|Study Chair:||Chang-Yi Wang, Ph.D.||United Biomedical Inc., Asia|
|Responsible Party:||United Biomedical Inc., Asia|
|Other Study ID Numbers:||
|First Posted:||February 26, 2021 Key Record Dates|
|Last Update Posted:||August 26, 2022|
|Last Verified:||June 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases