A Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine

Study Overview
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Brief Summary
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This is a phase I, open-label, dose-escalation clinical study to evaluate the safety, tolerability and immunogenicity of 3 ascending doses of UB-612 COVID-19 vaccine in healthy adults, aged from 20 to 55 years old.

Detailed Description
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This is a phase I, open-label, dose-escalation clinical study to evaluate the safety, tolerability and immunogenicity of 3 ascending doses of UB-612 COVID-19 vaccine in healthy adults. Up to 60 subjects (20 subjects per group) will be enrolled into this study. Subjects in each group will be enrolled to receive two doses of UB-612 vaccine at 28-day interval (Day 0 and Day 28).

Official Title
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A Phase I, Open-label Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 Vaccine in Healthy Adult Volunteers

Conditions
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COVID-19

Intervention / Treatment
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* Biological: UB-612


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or non-pregnant female between the age of 20 and 55 years at time of enrollment. 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. Negative serological test for Hepatitis B surface antigen (HBsAg), HCV RNA and HIV antibody screening. Negative in serum antibodies (IgG) against SARS-CoV-2 ELISA. Negative result of RT-PCR screening of nasopharyngeal or throat swabs for SARS-CoV-2. Ear temperature ≤ 38.0°C. The body mass index (BMI) of 18-30 kg/m2, inclusive, at screening. Indexes of blood routine, biochemistry and other laboratory tests are within the normal ranges, or not clinically significant as judged by investigators. Judged to be healthy by the investigator on the basis of medical history, physical examination, 12-lead ECG, vital signs, and clinical laboratory tests performed at screening. 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. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. Known history of SARS or MERS. Previous exposure to SARS-CoV-2 or receipt of an investigational vaccine product for the prevention of COVID-19, MERS or SARS. Subjects who take part in another clinical study within 12 weeks prior to the day of informed consent. With certain underlying medical conditions which are at increased risk for severe illness from COVID-19. Congenital or acquired angioedema. Immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease or immunosuppressive 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. Prior administration of attenuated, nucleic acid (mRNA or DNA) or vectored vaccines in last 1 month before first vaccination or expectation of such vaccines in the month after the second vaccination. Prior administration of subunit vaccine or inactivated vaccine in last 14 days before first vaccination or expectation of receipt of such vaccines in the 14 days after the second vaccination. Current anti-tuberculosis (TB) therapy or history of TB. Alcoholism or substance abuser. History of malignancy within 5 years prior to screening visit, except basal cell carcinoma of the skin and cervical carcinoma in situ. 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (Low dose)<br>20 subjects will be enrolled to receive low dose of UB-612 vaccine. | Biological: UB-612<br>* UB-612 is 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.<br>|
| Experimental: Group B (Medium dose)<br>20 subjects will be enrolled to receive medium dose of UB-612 vaccine. | Biological: UB-612<br>* UB-612 is 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.<br>|
| Experimental: Group C (High dose)<br>20 subjects will be enrolled to receive high dose of UB-612 vaccine. | Biological: UB-612<br>* UB-612 is 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of UB-612 vaccine | Occurrence of adverse reactions within 7 days after vaccination Percentage of subjects with ≥ Grade 3 adverse events within 7 days after vaccination | 7 days following vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Occurrence of adverse events (AEs) till Day 56 Occurrence of serious adverse events (SAEs) till Day 56 | Day 0 to Day 56 | 
| Safety | Occurrence of serious adverse events during the whole follow-up period | Day 29 to Day 196 | 
| Safety | Occurrence of adverse events of special interest during the study period | Day 0 to Day 196 | 
| Immunogenicity | Geometric mean titer (GMT) of antigen-specific antibody (Anti-S1-RBD) | Day 14, 28, 42, 56, 112, and 196 | 
| Immunogenicity | Seroconversion rate (SCR) of antigen-specific antibody (Anti-S1-RBD) | Day 14, 28, 42, 56, 112, and 196 | 
| Immunogenicity | Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD) | Day 14, 28, 42, 56, 112, and 196 |