COVID-19

Main test purpose -Assess the immune response and the durability of the immune response over time by the preventive UB-612 vaccine. -Assess the safety and tolerability of UB-612 vaccine after vaccination. Secondary test purpose -Assess the immune response to the new coronavirus during the trial. -Evaluate the consistency of batch immunization of three independent batches of vaccine. -Describe the hematological response of UB-612 vaccine in confirmed and/or severe cases of new coronavirus infection.

UB-612

S1-RBD-sFc融合蛋白與Th和CTL胜肽

Injection

200

1. Main evaluation indicators
1. Safety assessment indicators
(1) Adverse reactions within 7 days after each dose of vaccination).
(2) Systemic adverse events within 7 days after each dose of vaccination.
(3) Unexpected adverse events from the first dose of vaccine to the last 2 months after vaccination.
(4) Adverse events and serious adverse events during medical visits within 6 months from the first dose of vaccine to the last dose of vaccination.
(5) Special adverse events and antibody-dependent enhancement events within 6 months after the first dose of vaccine to the last dose of vaccine.

2. Immunogenicity evaluation index
(1) The seroconversion rate of specific antigen Anti-S1-RBD antibody and SARS-CoV-2 neutralizing antibody during the first and six months after the second dose of vaccination.
(2) The geometric mean titer of specific antigen Anti-S1-RBD antibody and SARS-CoV-2 neutralizing antibody at the first and sixth months after the second dose of vaccination.
(3) The geometric mean titer of specific antigen Anti-S1-RBD antibody and SARS-CoV-2 neutralizing antibody increased by multiples from the 1st and 6th month after the second dose of vaccination.

2. Secondary evaluation indicators
1. Safety assessment indicators
(1) Changes in laboratory values.

2. Immunogenicity evaluation index
(1) Compare the batch consistency measured by the geometric mean titers of SARS-CoV-2 neutralizing antibodies caused by three independent clinical vaccines of UB-612 vaccine on day 57. The 95% confidence interval between groups should be between 0.5 and 2.
(2) Described in cases of confirmed and/or severe infection with the new coronavirus, the Anti-S1-RBD immunoglobulin G concentration and SARS-CoV-2 neutralizing antibody titer triggered by the UB-612 vaccine.

(1) Healthy male or non-pregnant female subjects between the ages of 12-85 at the time of inclusion in the trial.
(2) Women and men of fertility should agree to effective contraception from the first vaccination to 3 months after the last vaccination. Acceptable and effective methods of contraception include:
a. Males or females are sterilized by surgical methods, implanted contraceptives, or uterine contraceptives.
b. Injectable contraception, contraceptive pills, contraceptive patch, contraceptive ring plus a barrier method of contraception*.
c. Combine two barrier contraceptive methods*.
* Effective barrier contraceptive methods are contraceptive diaphragms, male or female condoms, contraceptive sponges or spermicides (ointments or gels containing spermicidal chemicals).
(3) Able to understand the explanation and possible risks of the subject's consent form, and provide a signed subject's consent form.
(4) Able to understand and follow this test procedure and be able to participate in each visit.
(5) Ear temperature ≤ 38.0°C.
(6) According to the medical history, physical examination, and clinical judgment of the trial host, the subjects** who are healthy are eligible for inclusion in the trial. According to the trial host's judgment, even if the subject's medical history is stable or well-controlled, the risk of serious new coronavirus infection is increased with the deterioration of the condition.
** Healthy subjects with pre-existing stable disease can be included in the trial, which is defined as the disease that did not deteriorate to a significant change requiring treatment or hospitalization within 12 weeks before the trial was included and did not deteriorate to a significant change within 6 months of the included trial. Significant changes that require treatment or hospitalization.

(1) A history of anaphylactic shock, urticaria or other significant adverse reactions that require medical intervention after vaccination.
(2) Women who were pregnant or tested positive for pregnancy at the time of screening or before each dose of vaccine.
(3) Women who are breastfeeding, or women who plan to breastfeed from the first dose of vaccine to 60 days after the last dose of vaccine.
(4) Within 3 days before the first dose of vaccine, as judged by the test host, they have any acute disease (such subjects can be reassessed).
(5) It is known to be positive for human immunodeficiency virus antibodies.
(6) Known as active hepatitis B or hepatitis C. Active hepatitis is defined as a positive hepatitis B surface antigen test and a positive hepatitis C RNA test (the subject is positive for hepatitis C antibody and needs to be tested with hepatitis C RNA).
(7) Known to have been exposed to the new type of coronavirus, or have received trial products to prevent the new type of coronavirus, Middle East respiratory syndrome coronavirus, and severe acute respiratory syndrome.
(8) A history of Guillain-Barre syndrome.
(9) Participate in other clinical trials within 12 weeks before signing the subject's consent.
(10) Immune deficiency/disorders, whether caused by genetic defects, immunodeficiency or immunosuppressive therapy.
(11) Suffering from platelet abnormalities or other coagulation abnormalities may cause contraindications for injection.
(12) Long-term acceptance (≥ continuous use for 14 days) immunosuppressants, corticosteroids (equivalent to one day use of ≥ 20 mg prednisone) or cells 6 months before the first dose of vaccine Toxic treatment.
(13) Receiving immunoglobulin and/or any blood preparations 4 months before the first dose of vaccine.
(14) Inoculate any seasonal influenza vaccine or new influenza vaccine 14 days before the trial vaccine, or inoculate other non-test vaccines 28 days before.
(15) It is expected to receive any seasonal influenza vaccine or new influenza vaccine 14 days after the test vaccine, or other non-test vaccines 28 days later.
(16) Use short-term (<14 days use) systemic steroids. The trial vaccine should be used after stopping the use of systemic steroids for at least 28 days. Inhalation/spray, joint injection, intracapsular or topical (dermal or ophthalmic) steroids are permitted.
(17) Donate more than 500ml of blood in the 3 months before the screening period, or expect to donate blood or use blood preparations for blood transfusion during the trial period.
(18) As judged by the trial host, there are any medical diseases or conditions that may affect the results of the trial or participating in the trial may cause additional risks to the subjects.