Phase I Clinical Study of Recombinant Novel Coronavirus Vaccine

Inclusion Criteria:

- Comply with the observation age of this clinical trial: 18-59 years old (both
included) adults.

- The subjects themselves voluntarily agreed to participate in the study, and signed an
informed consent form, and can provide legal identification; understand and abide by
the requirements of the trial protocol; can participate in a half-year follow-up.

- Body temperature under armpit <37.3 ℃.

- Body mass index (BMI) at 18-28kg / m² (inclusive).

- Female and male subjects of childbearing age took effective contraception during the
study.

Exclusion Criteria:

- The vital signs, physical examination and laboratory test indicators of the population
specified in the plan are abnormal and have clinical significance as determined by the
clinician;

- Have a history of severe allergies to any component of the research vaccine, including
aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic
purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction); or any
previous History of serious side effects of vaccines or drugs, such as allergies,
urticaria, skin eczema, dyspnea, angioedema, etc .

- Those with a history of SARS and COVID-19, meet any of the following:

1. previous history of SARS-CoV and SARS-CoV-2 infection or morbidity;

2. during the current SARS-CoV-2 epidemic, there is a diagnosis with the new crown
Patient / suspected patient contact history;

3. positive for SARS-CoV-2 IgM and / or IgG antibodies;

4. positive for real-time fluorescent RT-PCR nucleic acid.

- Have taken antipyretics or painkillers within 24 hours before the first dose of
vaccine.

- Inoculate subunit vaccine and inactivated vaccine within 14 days before the first dose
of vaccination, and inoculate live attenuated vaccine within 30 days.

- People with the following diseases:

1. Acute febrile illness;

2. Digestive system diseases (eg, diarrhea, abdominal pain, vomiting, etc.) in the
past 7 days;

3. Congenital malformations or developmental disorders, genetic defects, severe
malnutrition, etc .;

4. Congenital or acquired immunodeficiency or autoimmune disease history or within 6
months of receiving immunomodulator treatment, such as hormones; or monoclonal
antibodies; or thymosin; or interferon, etc .; but local medications (such as
ointment are allowed , Eye drops, inhalation or nasal spray), local
administration should not exceed the dosage recommended in the instructions or
have any signs of systemic exposure;

5. The chest imaging examination is clinically significant if the investigator
judges that the abnormality is clinically positive, or any positive of hepatitis
B surface antigen, hepatitis C virus antibody, human immunodeficiency virus HIV
antibody or syphilis specific antibody;

6. Neurological diseases or neurodevelopmental disorders (eg, migraine, epilepsy,
stroke, seizures in the last three years, encephalopathy, focal neurological
deficit, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis );
History of mental illness or family history;

7. Functional spleenlessness, and spleenlessness or splenectomy for any reason;

8. There are serious chronic diseases or conditions that cannot be controlled
smoothly in the advanced stage, such as diabetes and thyroid disease;

9. Severe liver and kidney diseases; respiratory diseases that currently require
daily medication (eg, chronic obstructive pulmonary disease [COPD], asthma) or
any treatment that exacerbates respiratory diseases (eg, exacerbated asthma)
within the last 5 years; suffers History of severe cardiovascular disease (such
as congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia,
conduction block, myocardial infarction, pulmonary heart disease) or myocarditis
or pericarditis;

10. have thrombocytopenia, any coagulopathy, or receive anticoagulant treatment, etc
.;

11. Cancer patients;

12. Have received blood or blood-related products, including immunoglobulin within 3
months; or plan to use it during the study.

- Lactating women or pregnant women (including blood or urine pregnancy test positive).

- Any research or unregistered product (medicine, vaccine, biological product or device)
other than the research product was used within 3 months before the application of the
test drug / vaccine, or planned to be used during the study.

- People with halo and halo needles.

- The investigator believes that the presence of any disease or condition in the subject
may put the subject at an unacceptable risk; the subject cannot meet the protocol
requirements; and interfere with the assessment of vaccine response.