COVID-19
Conditions
Interventions
Test vaccine group:SYS6006
Control vaccine group:SARS-CoV-2 recombinant protein vaccine
Sponsors
The First Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Adults aged 18 years or more; 2.Had received 2 or 3 doses of licensed SARS-CoV-2 inactivated vaccine at least 6 months before enrollment; 3.Have negative SARS-CoV-2 antigen test on the day of enrollment; to be eligible for the immunogenicity subgroup, the participants should also be negative for SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) test within 48 hours before enrollment; 4.Comply with the requirements of the protocol and be able to complete 6-month follow-up; 5.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, no sexual life with a man or used an effective contraceptive method when having sex without contraception failure; consent to abstain from sex activity or use adequate contraceptive methods from enrollment in the study to the 6-month follow-up after the vaccination; 6.Being in good health at the discretion of investigators based on medical history inquiry and physical examination; for the participants having underlying disease (e.g., chronic disease such as diabetes/hypertension/hyperlipidemia), they should be controlled stably (no need for additional medical intervention or no major adjustment for treatment regimen) at least 3 months before enrollment; 7.Understand the informed consent form (ICF) and voluntarily sign the ICF.
Exclusion criteria
Exclusion criteria: A participant who has any of the following condition should be excluded from the study: 1. history of SARS-CoV-2 infection within 6 months. 2. 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]); 3. axillary temperature = 37.3°C on the day of enrollment or within 24 h before enrollment; 4. current epilepsy or convulsion, neurological disorders or mental diseases; 5. active malignant tumor, malignant tumor without adequate treatment, malignant tumor with a potential risk of recurrence during the study; 6. severe or uncontrolled cardiovascular, thrombotic, neurological, blood and lymphatic disorders, liver and kidney diseases, respiratory diseases, metabolic disease, musculoskeletal diseases, autoimmune diseases at enrollment; 7. congenital or functional splenia, or splenectomy for any reason; 8. receipt of immunosuppressive agents or other immunomodulatory drugs (e.g., corticosteroids, = 20 mg/d prednisone or equivalent; inhaled and topical steroids are allowed) for a long time (defined as more than 14 days) within 6 months before vaccination; 9. receipt of other inactivated vaccines or recombinant vaccines within 7 days, or live attenuated vaccines within 14 days before enrollment; 10.receipt of blood products and/or immunoglobulins within 3 months before enrollment, or planning to receive these products during the study; 11. history of blood donation or blood loss = 450 mL within 1 month before enrollment, or planning to donate blood during the study; 12. is participating in or planning to participate in other clinical studies during the study; 13. For female participant of childbearing potential: having positive urine pregnancy test before vaccination; being in pregnancy or lactation; planning to be pregnancy within 6 months after enrollment. For male participant having spouse of childbearing potential: his spouse is planning to be pregnancy within 6 months after enrollment; 14. history of contraindications to intramuscular injection, e.g., diagnosed thrombocytopenia, any coagulation disorders, or treatment with anticoagulants, etc; 15. inappropriate for the study at the discretion of the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Solicited (local and systemic) adverse events (14 days after vaccination);Unsolicited adverse events (28 days after vaccination);GMT of live virus neutralizing antibodies at D14; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious Adverse Events (SAEs) (6 months after vaccination);Adverse Events of Special Interest (AESI) (6 months after vaccination);Pregnancy Events;GMT of live virus neutralizing antibodies at D28;GMT of specific IgG antibodies at D14 and D28;GMFI and SCR of live virus neutralizing antibodies at D14 and D28;GMFI and SCR of specific IgG antibodies at D14 and D28;GMT, GMFI and SCR of live virus neutralizing antibodies at D90 and D180;GMT, GMFI and SCR of specific IgG antibodies at D90 and D180; | — |
Countries
China
Contacts
Public ContactZhou Chunhua
The First Hospital of Hebei Medical University
Outcome results
None listed