Prevent COVID-19 infection

Primary Objective: To evaluate the safety and tolerability of the UB-612 vaccine in healthy adults. Secondary Objective: To evaluate the immunogenicity of the UB-612 vaccine in healthy adults

UB-612

Vial

20 μg/ml、60 μg/ml、200 μg/ml

Primary Endpoint(s):
 Occurrence of adverse reactions within 7 days after vaccination
 The percentage of subjects with ≥ Grade 3 adverse events within 7 days after vaccination
Secondary Endpoint(s):
 Occurrence of adverse events (AE) till Day 56
 Occurrence of serious adverse events (SAE) till Day 56
 Occurrence of serious adverse events during the whole follow-up period (6 months)
 Occurrence of adverse events of special interest during the study period
 Changes of safety laboratory measures
 Geometric mean titer (GMT) of antigen-specific antibody (Anti-S1-RBD) on Day 14, 28, 35, 56, 112, and
196.
 Seroconversion rate (SCR) of antigen-specific antibody on Day 14, 28, 35, 56, 112, and 196.
 Geometric mean fold increase of antigen-specific antibody on Day 14, 28, 35, 56, 112, and 196.
Exploratory Endpoint(s):
 GMT of neutralizing antibody against SARS-CoV-2 on Day 14, 28, 35, 56, and 196
 SCR of neutralizing antibody against SARS-CoV-2 on Day 14, 28, 35, 56, and 196
 Geometric mean fold increase of neutralizing antibody against SARS-CoV-2 on Day 14, 28, 35, 56, and 196
 Correlation between the immune response detected by ELISA and live virus neutralization test
 Positive rate and level of antigen-specific interferon-gamma (IFN-γ)/IL-4 measured by ELISpot on Day 7,
28, 35, and 196.
 CD4+
and CD8+ T cell responses using intracellular cytokine staining and flow cytometry on Day 7, 28, 35,
and 196.

1. Healthy male or non-pregnant female between the age of 20 and 55 years at time of enrolment.
2. Women of childbearing potential and men must agree to practice medically effective contraception from first
vaccination until 3 months after the last vaccination. The acceptable effective contraception methods
include male or female sterilization, implant, intrauterine device, injectable, pill, patch, or ring.
3. Able to understand the content and possible risks of informed consent and willing to sign the Informed
Consent Form (ICF).
4. Able to understand and agrees to comply with all study procedures and be available for all study visits.
5. Negative serological test for Hepatitis B surface antigen (HBsAg), HCV RNA and HIV antibody screening.
6. Negative in serum antibodies (IgG) against SARS-CoV-2.
7. Negative result of RT-PCR (Reverse Transcriptase PCR) screening of nasopharyngeal or throat swabs for
SARS-CoV-2.
8. Ear temperature ≤ 38.0°C.
9. The body mass index (BMI) of 18-30 kg/m2
, inclusive, at screening.
10. Indexes of blood routine, biochemistry and other laboratory tests* are within the normal ranges, or not
clinically significant as judged by investigators.
11. Judged to be healthy by the investigator on the basis of medical history, physical examination, 12-lead
ECG, vital signs (systolic/diastolic blood pressure, pulse rate, body temperature, respiratory rate), and
clinical laboratory tests (blood biochemistry, routine) performed at screening.

1. History of anaphylaxis, urticarial, or other significant adverse reaction requiring medical intervention after
receipt of a vaccine.
2. Female who is pregnant or positive in pregnancy test at screening or just prior to each vaccination
administration.
3. Female who is breast-feeding or plans to breastfeed from the time of the first vaccination through 60 days
after the last vaccination.
4. Any acute illness, as determined by the study investigator 3 days before first vaccination.
5. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary,
gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug
allergies).
6. Known history of SARS or MERS.
7. Previous exposure to SARS-CoV-2 or receipt of an investigational vaccine product for the prevention of
COVID-19, MERS or SARS.
8. Subjects who take part in another clinical study within 12 weeks prior to the day of informed consent.
9. With certain underlying medical conditions which are at increased risk for severe illness from COVID-19,
such as chronic kidney disease, COPD (Chronic Obstruction Pulmonary Disease), serious heart conditions
(e.g., heart failure, coronary heart disease, or cardiomyopathies), or with major chronic illness, such as asthma,
diabetes, or thyroid disease, and other not well-controlled.
10. Congenital or acquired angioedema.
11. Immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease or
immunosuppressive therapy.
12. Platelet disorder or other bleeding disorder may cause injection contraindication.
13. Prior chronic administration (defined as ≥ 14 day of continuous use) of immunosuppressant or corticosteroids
(equivalent to ≥ 20 mg daily of prednisone), cytotoxic treatment in last 6 months before first vaccination.
14. Prior administration of immunoglobulins and/or any blood products in last 4 months before first vaccination.
15. 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.
16. 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.
17. Current anti-tuberculosis(TB) therapy or history of TB.
18. Alcoholism or substance abuser.
19. History of malignancy within 5 years prior to screening visit, except basal cell carcinoma of the skin and
cervical carcinoma in situ.
20. 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.