| Eligibility |
Inclusion Criteria:
1. Adults aged 18 years and older, Body Mass Index (BMI) is between 18-30, able to
provide legal proof of identity
2. Participants voluntarily agreed to participate in the study and signed an informed
consent form
3. The subject has the ability to understand the study process and is willing and able to
comply with all study proposals and other requirements of the study
4. Be willing and able to comply with protocol and complete 12-month study follow-up
5. Have received 2 doses of inactivated SARS-CoV-2 vaccine for 6 months and less than 12
months before enrollment
6. Male and female subjects of childbearing age agree to use effective contraception from
screening period until 12 months after vaccination; female subjects of childbearing
age have taken effective contraceptive measures 1 month before enrollment
7. Female subjects of childbearing age are not at pregnant period (negative result of
pregnancy test) or lactation period
8. Male and female subjects of child-bearing age agree that do not donate eggs (eggs,
oocytes) for assisted reproduction (female subjects of reproductive age) or avoid
sperm donation (male subjects) from screening period until 12 months after vaccination
Exclusion Criteria:
1. Have received any SARS-CoV-2 vaccines other than 2 doses of the inactivated vaccine
2. History of Severe Acute Respiratory Syndrome (SARS), Coronavirus disease 2019
(COVID-19), Middle East Respiratory Syndrome (MERS) and other human coronavirus
infections or disease
3. Positive SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) test
4. The vital signs or physical examination are clinically significant abnormal as
determined by the investigators in screening
5. Fever (axillary temperature=37.3°C) on the day of the vaccination
6. A history of severe allergy (including drugs, vaccines, and foods) or to any component
of the experimental vaccine, e.g., allergic shock, laryngeal edema, anaphylactoid
purpura, dyspnea, and angioedema, etc.
7. Subjects have contraindications to intramuscular injection, such as having been
diagnosed with thrombocytopenia, any blood clotting disorder, or receiving
anticoagulant therapy
8. Subjects have been diagnosed with a serious disease, congenital malformation or
chronic disease (including but not limited to respiratory disease or bronchitis such
as asthma, serious cardiovascular disease, serious cerebrovascular disease, kidney
disease, serious or uncontrollable diabetes, autoimmune disease, thrombocytopenic
purpura, thalassemia, malignant tumor, hereditary allergic constitution, etc.) that
may interfere with the conduct or completion of the study
9. Diagnosed with diseases may affect immune system function, including malignant tumor,
congenital or acquired immune deficiency or suppression (e.g., tuberculosis, human
immunodeficiency virus (HIV)), Hepatitis B, hepatitis C, syphilis infection,
uncontrollable autoimmune disease, no spleen or spleen dysfunction
10. History or family history of central nervous system disease, convulsions or tics,
epilepsy, meningitis, neurological disorders, mental disorders, cerebritis, myelitis,
Guillain-Barre syndrome, etc
11. Long-term use of immunopotentiator or immunosuppressant therapy within 6 months prior
to vaccination (continuous oral or injection for more than 14 days)
12. Use of any blood or blood-related products (e.g., blood transfusion, use of human
albumin, human immunoglobulin, etc.) or have received solid organ or bone marrow
transplantation within 3 months prior to vaccination
13. Lymph node - related diseases (such as lymphadenitis, lymph node adhesion, lymph node
tuberculosis, tumor metastasis, etc.) or skin scars and fistulas at the lymph node
site, or lymphadenopathy, tenderness, skin redness and swelling at the lymph node site
within 7 days prior to vaccination
14. Within 3 days prior to vaccination, an acute illness or attack of a chronic disease,
or the use of antipyretic analgesic or anti - allergic drugs
15. Other vaccines have been administered within 4 weeks prior to the trial vaccination or
other vaccination schedule (except for emergency vaccinations such as Rabies vaccine
and Tetanus vaccine) between the screening period and 28 days after the vaccination
16. Participating in or planning to participate in other clinical trials (drugs or
vaccines) within 3 months prior to participating in this study
17. Any blood loss >400 mL (e.g., donation of blood or blood components or injury) within
28 days prior to the screening visit, or plans to donate blood or blood components
between the screening visit and 28 days post-vaccination
18. Any abnormal or permanent body art (such as tattoos) at the site of the vaccination,
which the researchers think to interfere with observing local reactions at the site of
the vaccination
19. Other circumstances considered by the investigator as inappropriate to participate in
the study
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