SARS-CoV-2 (COVID-19)
Conditions
Interventions
Investigational vaccine group:a bivalent SARS-CoV-2 mRNA vaccine
Control vaccine group:SARS-CoV-2 mRNA vaccine
Sponsors
Sir Run Run Hospital, Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The participant must meet all of the following inclusion criteria: 1. Adults aged 18 years or more; 2. Have completed primary vaccination with SARS-CoV-2 vaccines (1 dose of recombinant adenovirus vector vaccine, 2 doses of inactivated vaccine or 3 doses of recombinant protein vaccine), regardless of a booster dose; with an interval of at least 6 months since the last dose; and not received SARS-CoV-2 mRNA vaccine previously; 3. Negative for SARS-CoV-2 antigen test on the day of enrollment, and negative for SARS-CoV-2 nucleic acid test (RT-PCR method) within 48 hours; 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, had no sexual activity with a man, or had sexual activity with a man but used an effective contraceptive measure and without contraception failure; consent to abstain from sex activity or use effective contraceptive measures from enrollment into the study through 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 chronic underlying disease (e.g., diabetes/hypertension/hyperlipidemia, etc), they should be under stable control (i.e., no need for additional medical intervention or no major adjustment for treatment regimen) for at least 3 months before enrollment; 7. Have independent judgment and participate voluntarily; able to read and write, understand the content of the informed consent form and voluntarily sign the informed consent form.
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 5 months. 2. History of allergy to any component of the investigational vaccine or history of severe allergic reaction to vaccines or drugs (including but not limited to anaphylaxis, allergic laryngeal edema, Henoch-Schonlein 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 uncontrollable cardiocerebrovascular, thrombotic, neurological, blood and lymphatic disorders, liver and kidney diseases, respiratory diseases, metabolic diseases, musculoskeletal diseases, autoimmune diseases at enrollment; 7. Congenital or functional asplenia, or splenectomy for any reason; 8.Within 6 months before vaccination, receipt of immunosuppressive agents or other immunomodulatory drugs (e.g., corticosteroids, = 20 mg/d prednisone or equivalent) for a long time (defined as more than 14 days); inhaled and topical steroids are allowed; 9. Within 3 months before enrollment, receipt of blood products and/or immunoglobulins; or planning to receive these products during the study; 10. Within 1 month before enrollment, blood donation or blood loss = 450 mL or planning to donate blood during the study; 11. Receipt of other inactivated vaccines or recombinant vaccines within 7 days, or live attenuated vaccines within 14 days before enrollment; 12. Is participating in or planning to participate in other clinical studies during the study; 13. For female participant of childbearing potential: has positive urine pregnancy test before vaccination; being in pregnancy or lactation; plans 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. Is inappropriate for the study at the discretion of the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean titer (GMT) of SARS-CoV-2 live virus neutralizing antibodies ;Seroconversion rate (SCR) of SARS-CoV-2 live virus neutralizing antibodies;Solicited (local and systemic) adverse events (AEs) ;Unsolicited AEs; | — |
Secondary
| Measure | Time frame |
|---|---|
| GMT of SARS-CoV-2 live virus neutralizing antibodies ;SCR of SARS-CoV-2 live virus neutralizing antibodies ;Geometric mean fold increase (GMFI) of SARS-CoV-2 live virus neutralizing antibodies ;GMT, GMFI and SCR of SARS-CoV-2 live virus neutralizing antibodies ;GMT, GMFI and SCR of SARS-CoV-2 pseudovirus neutralizing antibodies ;GMT, GMFI and SCR of SARS-CoV-2 pseudovirus neutralizing antibodies ;Serious adverse events (SAEs);Adverse events of special interest (AESIs);Pregnancy event; | — |
Countries
China
Contacts
Public ContactXiang Lu/Yuwen Su
Sir Run Run Hospital, Nanjing Medical University
Outcome results
None listed