The purpose of this study is to evaluate the immunogenicity and safety of the recombinant novel coronavirus vaccine (CHO cells) after the booster immunization. It is planned to screen 300 subjects of 18 years old and above who have completed the basic immunization of recombinant novel coronavirus vaccine (CHO cells), to evaluate the immunogenicity and safety of the booster immunization of 12 months (window period ± 3 months) after the basic immunization. Investigate the geometric mean titer (GMT), GMI and 4 times growth rate of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody 14 days, 30 days, and 6 months after booster vaccination; the incidence of all AEs within 1 month after the booster vaccination, the incidence of all serious adverse events (SAE) within 6 months after the booster vaccination.
This study adopts an open experimental design. It is planned to screen 300 subjects of 18 years old and above who have completed the basic immunization of recombinant novel coronavirus vaccine (CHO cells), to evaluate the immunogenicity and safety of the booster immunization of 12 months (window period ± 3 months) after the basic immunization. Immunogenicity observation: the geometric mean titer (GMT), GMI and 4 times growth rate of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody 14 days, 30 days, and 6 months after booster vaccination. Safety observation: All adverse events (AE) were collected within 30 minutes after the booster immunization, all AEs (including both solicited and unsolicited AEs) 0-7 days after the booster immunization, and all AEs (unsolicited AEs) 8-30 days after the booster immunization. Solicited AE (the following events occurring within 7 days of vaccination) : Adverse events at the inoculation site (local) : pain, pruritus, redness, swelling, rash, induration; Non-inoculated site (systemic) adverse events: fever, headache, fatigue, diarrhea, nausea, vomiting, muscle pain (non-inoculated site), acute allergic reactions, cough. All SAEs were collected within 6 months after the booster immunization.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
300
At 12 months after the basic immunization (window period ± 3 months), 1 dose of recombinant novel coronavirus vaccine (CHO cells) is vaccinated.
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China
Immunogenicity endpoint
Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody
Time frame: 14 days after booster vaccination
Immunogenicity endpoint
Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody
Time frame: 30 days after booster vaccination
Immunogenicity endpoint
Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody
Time frame: 6 months after booster vaccination
Immunogenicity endpoint
GMI and 4 times growth rate of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody
Time frame: 14 days, 30 days, and 6 months after booster vaccination
Safety endpoint
Incidence of all AEs
Time frame: Within 1 month after booster vaccination
Safety endpoint
Incidence of all SAEs
Time frame: Within 6 months after booster vaccination
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