A Phase II/III Study of PIKA Recombinant SARS-CoV-2 Vaccine as a Booster Dose.

Inclusion Criteria:

Subject who met all of the following criteria may be enrolled.

1. Age more than or equal 18 years on Screening.

2. Judged by the investigator to be healthy based on medical history, physicalexamination and vital signs performed at screening.

3. Able to provide informed consent.

4. Able and willing to comply with all study procedures over follow up period ofapproximately 12 months.

5. Received 2 or more doses of inactivated COVID-19 vaccine as primary series withtheir last dose at least 3 months prior to enrollment.

6. Axillary body temperature ≤37.5℃.

7. SARS-COV-2 test was negative for nasopharyngeal swabs by RT PCR.

8. Non-pregnant and not lactating women.

9. For female subjects of childbearing potential: must agree to avoid pregnancy fromStudy Day 0 to Study Day 60 during the study. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses ifmenopausal) in sexual relationships with men must use an acceptable method ofavoiding pregnancy during this period. Acceptable methods of avoiding pregnancyinclude a sterile sexual partner, sexual abstinence (not engaging in sexualintercourse), hormonal contraceptives (oral, injection, transdermal patch, orimplant), vaginal ring, intrauterine device (IUD), or the combination of a condom ordiaphragm with spermicide.

10. Male subjects who are sexually active with a woman of childbearing potential andhave not had vasectomy must agree to practice a highly effective form ofcontraception with their female partners of childbearing potential during the trial,starting after screening until 60 days after receiving the last vaccination.

11. Men must be willing to refrain from sperm donation, starting after screening until 60 days after receiving the last vaccination.

Exclusion Criteria:

• Subject who met any of the following criteria may not be enrolled.

1. Abnormal vital signs or laboratory test results prior to D0 judged asclinically significant by investigator.

2. Known allergy, hypersensitivity, or intolerance to the test vaccine (includingany excipients and the antibiotics kanamycin and aminoglycosides).

3. History of severe allergies to any drugs, foods or vaccines, such asanaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergicpurpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthusreaction), etc.

4. Diagnosed with any serious disease, or congenital malformation, or uncontrolledchronic disease that may influence the compliance with the study including butnot limited to respiratory disease such as asthma or chronic bronchitis,serious cardiovascular disease, kidney disease, autoimmune disease,thalassemia, malignant tumor, hereditary allergy, etc.

5. History or family history of convulsions, seizures, encephalopathy, and mentalillness.

6. History of narcolepsy.

7. Known substance abuse and addiction within the past 2 years.

8. Uninterrupted use of systemic immunosuppressants or other immunomodulatorswithin 30 days prior to D0.

9. Use of blood or blood-related products (e.g., blood transfusion, human albumin,human immunoglobulin, etc.) within 30 days prior to D0.

10. Blood loss >400 mL within 28 days prior to D0 (e.g., donated blood or bloodproducts or injury), or planned to donate blood or plasma before D28 of thestudy.

11. Use of nonsteroidal anti-inflammatory drugs and/or antiallergic drugs within 3days prior to D0

12. Have symptoms of COVID-19, such as respiratory symptoms, fever, cough,shortness of breath and dyspnea.

13. Bleeding disorder, or receipt of anticoagulants in the past 21 days precedinginclusion, contraindicating IM vaccination based on Investigator's judgment.

14. Surgical removal of whole or part of spleen for any reason

15. Received any vaccines within 28 days prior to D0 or disagree to avoid receivingany vaccines before D28 of the study except the emergent vaccination such asrabies vaccine, tetanus vaccine.

16. Participating in or planning to participate in other clinical trials (drugs orvaccines) during the study period.

17. Any other conditions not eligible for participating in the study atinvestigator's discretion.