A Phase Ⅲ Clinical Trial of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell) in Booster Vaccination

A Multicenter, Randomized, Double-Blind, Controlled, Phase Ⅲ Clinical Trial of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell) in Booster Vaccination to Evaluate Efficacy, Safety and Immunogenicity in Healthy Population Aged 18 Years Old and Above

Inclusion criteria

• Subjects aged 18 years and above, including those with underlying diseases and immunocompromised subjects.
• Basic or booster immunization with COVID-19 vaccine ≥6 months.
• ≥3 months of SARS-CoV-2 infection history, or never infected.
• Have the ability to understand research procedures, with informed consent, voluntarily sign informed consent, and be able to comply with the requirements of clinical research protocols.

Exclusion criteria

• Axillary temperature ≥37.3℃.
• SARS-CoV-2 antigen or nucleic acid screening positive within the last 48 hours.
• Anti-SARS-CoV-2 IgM antibody was positive during the screening period.
• It is in the advanced stage of malignant tumor and the disease control is unstable.
• Female pregnancy (pregnancy test results are positive), lactation period.
• Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, heart failure, severe hypertension, and can not be controlled by drugs.
• Have other serious chronic conditions such as uncontrolled asthma, diabetes, chronic obstructive pulmonary disease, pulmonary embolism, chronic kidney disease requiring dialysis, cirrhosis of the liver, convulsions, epilepsy and other neurological/psychiatric conditions.
• Have been diagnosed with congenital or acquired immunodeficiency, HIV infection.
• People who are allergic to any component of the investigational vaccine have a history of more severe allergies or allergic reactions to the vaccine in the past.
• Congenital or acquired angioedema/neuroedema.
• Asplenia or functional asplenia.
• Thrombocytopenia or other clotting disorders (which may cause intramuscular injection contraindications).
• Received another investigational drug within 1 month prior to receiving the investigational vaccine.
• Received subunit or inactivated vaccine within 14 days prior to receiving the investigational vaccine, or received live attenuated vaccine within 1 month.
• Fertile female subjects did not use effective contraception within 1 month prior to enrollment.
• Fertile female and male subjects have pregnancy plans and sperm/egg donation plans from the screening period to 3 months after immunization.
• Abnormal laboratory test results during the screening period, which were judged by the researcher to be unsuitable for the study vaccine.
• Medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's signing of informed consent.