COVID-19
Conditions
Interventions
Experimental vaccine group:SYS6006.32
Sponsors
Sir Run Run Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or more; 2. Have completed the basic immunization program of SARS-CoV-2 vaccines, regardless of whether the booster immunization has been vaccinated; and at least 3 months apart from the last dose before enrollment; Have not received SARS-CoV-2 mRNA vaccine; 3. Comply with the requirements of the protocol and be able to complete 12-month follow-up; 4. For female participants of childbearing potential, or the spouse of childbearing potential of male participant: from the first day of the last menstrual cycle to the day of enrollment, there has been no sexual activity with a male, or effective contraceptive measures have been used during sexual activity with a male, and no contraceptive failure has occurred; Agree to abstain from sexual activity or use effective contraceptive methods during the 6-month follow-up period from enrollment in this study to vaccination; 5. Being in good health at the discretion of investigators based on medical history inquiry, physical examination and laboratory examination; For subjects with chronic underlying diseases, if their condition is stably controlled within at least 3 months before enrollment in this study, they can be enrolled; If there are laboratory test results that exceed the normal range before enrollment, but are within the level 1 (inclusive) standard range specified in the Guiding Principles for the Classification of Adverse Events in Clinical Trials of Preventive Vaccines (2019) issued by the National Medical Products Administration or other applicable adverse event classification standards referenced in this plan, enrollment is allowed; 6. Have independent judgment ability and voluntarily participate; Have the ability to read and write, understand the informed consent form (ICF) and voluntarily sign the ICF.
Exclusion criteria
Exclusion criteria: 1. History of SARS-CoV-2 infection within 3 months. 2. Have positive SARS-CoV-2 antigen test within 48 hours before enrollment; 3. Have positive SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) test within 48 hours before enrollment; 4. Have positive SARS-CoV-2 IgM test within 48 hours before enrollment; 5. History of allergy to any component of the investigational vaccine or history of severe allergic reaction to the vaccine or drug (including but not limited to anaphylaxis, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenia purpura or local allergic necrosis [Arthus reaction]); 6. Axillary temperature = 37.3°C on the day of enrollment or within 24 h before enrollment; 7. Current epilepsy or convulsion, neurological disorders or mental diseases; 8. History of contraindications to intramuscular injection; 9. Active malignant tumor, malignant tumor without adequate treatment, malignant tumor with a potential risk of recurrence during the study; 10. Serious or uncontrollable cardiovascular and cerebrovascular diseases, thrombotic diseases, neurological diseases, blood and lymphatic system diseases, liver and kidney diseases, respiratory system diseases, metabolic, musculoskeletal, immune system diseases, etc; 11. Diagnosis of immune impairment or low function before enrollment; Congenital or functional absence of spleen or splenectomy; 12. Receipt of immunosuppressive agents, immune enhancers or other immunomodulatory drugs, except for inhaled and topical steroids; Or plan to receive these products during the study; 13. Receipt of whole blood, plasma or immunoglobulins within 3 months before enrollment, or planning to receive these products during the study; 14. History of blood donation or blood loss = 450 mL within 1 month before enrollment, or planning to donate blood during the study; 15. Receipt of other inactivated vaccines or recombinant vaccines within 7 days, or live attenuated vaccines within 14 days before enrollment; 16. Is participating in or planning to participate in other clinical studies during the study; 17. Having positive urine pregnancy test for female participant of childbearing potential before vaccination; being in pregnancy or lactation; or having pregnancy plans within 6 months after enrollment. Male subjects with spouses of childbearing age: their spouses have pregnancy plans within 6 months of enrollment; 18. Participants that cannot comply with study procedures and conventions, or other conditions that were inappropriate for the study at the discretion of the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Solicited (local and systemic) adverse events;Unsolicited adverse events;Geometric Mean Ttiter (GMT), Geometric Mean Fold Increase (GMFI) and Seroconversion rate (SCR) of live-virus neutralizing antibodies;GMT, GMFI and SCR of pseudoviral neutralizing antibodies; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious Adverse Events (SAE);Adverse Events of Special Interest (AESI);Adverse Events associated with laboratory tests;Pregnancy event;GMT, GMFI and SCR of live-virus neutralizing antibodies;GMT, GMFI and SCR of pseudoviral neutralizing antibodies; | — |
Countries
China
Contacts
Public ContactLu Xiang, Su Yuwen
Sir Run Run Hospital of Nanjing Medical University
Outcome results
None listed