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Under the limited resources, to re-plan the ongoing clinical trials of this product.
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| Name | Class |
|---|---|
| Vaxxinity, Inc. | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UB-612 | Experimental | A proprietary high-precision designer S1-RBD protein based vaccine incorporating Th/CTL peptides to activate T cells. |
|
| Placebo | Placebo Comparator | Normal saline 0.9%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UB-612 | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer (GMT) of SARS-CoV-2 neutralizaing antibody | Immunogenicity evaluation | Day 57 |
| Seroconversion rate (SCR) of SARS-CoV-2 neutralizing antibody | Immunogenicity evaluation | Day 57 |
| Local reactions and systemic events | Safety evaluation | Up to 7 days following each dose |
| Unsolicited adverse events | Safety evaluation | Day 1 to Day 57 |
| Medically attend adverse events (MAAEs), serious adverse events (SAEs), adverse event of special interests (AESIs) and antibody dependent enhancements (ADEs) | Safety evaluation | Day 1 to Day 365 |
| Measure | Description | Time Frame |
|---|---|---|
| SCR of anti-S1-RBD antibody | Immunogenicity evaluation | Day 57 |
| GMT of SARS-CoV-2 neutralizing antibody | Immunogenicity evaluation | Day 197 and 365 |
| Measure | Description | Time Frame |
|---|---|---|
| Antigen-specific interferon-gamma (IFN-γ) and IL-4 production measured by ELISpot | Evaluation of T cell function induced by UB-612 | Day 57 and 14 days post 3rd dose |
| CD4+ and CD8+ T cell responses measured by flow cytometric assays |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chang-Yi Wang, Ph.D. | United Biomedical Inc., Asia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhua Christian Hospital | Changhua | Taiwan | ||||
| Chang-Geng Medical Foundation Kaoshiung Chang Gung Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37079651 | Derived | Wang CY, Peng WJ, Kuo BS, Ho YH, Wang MS, Yang YT, Chang PY, Shen YH, Hwang KP. Toward a pan-SARS-CoV-2 vaccine targeting conserved epitopes on spike and non-spike proteins for potent, broad and durable immune responses. PLoS Pathog. 2023 Apr 20;19(4):e1010870. doi: 10.1371/journal.ppat.1010870. eCollection 2023 Apr. | |
| 35316221 | Derived |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000722335 | UB-612 COVID-19 vaccine |
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| Placebo | Biological | Around 550 adult subjects and 55 adolescent subjects will receive 2 doses of normal saline 0.9%. |
|
| GMT of anti-S1-RBD antibody | Immunogenicity evaluation | Day 57, 197 and 365 |
| Geometric mean fold increase in SARS-CoV-2 neutralizing antibody and antigen-specific antibody (Anti-S1-RBD) | Immunogenicity evaluation | Day 57, 197 and 365 |
| Lot consistency by comparisons of GMT of SARS-CoV-2 neutralizing antibody | Evaluation of lot to lot consistency | Day 57 |
Evaluation of T cell function induced by UB-612
| Day 57 and 14 days post 3rd dose |
| GMT of SARS-CoV-2 neutralizing antibody | Immunogenicity evaluation | 14 days post 3rd dose |
| GMT of anti-S1-RBD antibody | Immunogenicity evaluation | 14 days post 3rd dose |
| Geometric mean fold increase in SARS-CoV-2 neutralizing antibody and anti-S1-RBD antibody | Immunogenicity evaluation | 14 days post 3rd dose |
| GMT of SARS-CoV-2 neutralizing antibody and anti-S1-RBD antibody in adolescents | Immunogenicity evaluation | Day 57, Day 197 and Day 365 |
| SCR of SARS-CoV-2 neutralizing antibody and anti-S1-RBD antibody in adolescents | Immunogenicity evaluation | Day 57 |
| Geometric mean fold increase in SARS-CoV-2 neutralizing antibody and anti-S1-RBD antibody in adolescents | Immunogenicity evaluation | Day 57, Day 197, and Day 365 |
| Safety evaluation in adolescents |
| Day 1 to Day 365 |
| Incidence of COVID-19 cases | COVID-19 incidence per 1000 person-years of follow-up | Day 1 to Day 365 |
| Antibody against SARS-CoV-2 antigens measured by ELISA | Antigens derived from S2, N and M protein. | Day 1 to Day 365 |
| Kaohsiung City |
| Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | Taiwan |
| Far Eastern Memorial Hospital | New Taipei City | Taiwan |
| China Medical University Hospital | Taichung | Taiwan |
| Taichung Veterans General Hospital | Taichung | Taiwan |
| National Cheng Kung University Hospital | Tainan | Taiwan |
| Taipei Medical University Hospital | Taipei | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Tri-Service General Hospital | Taipei | Taiwan |
| Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital | Taoyuan | Taiwan |
| 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |