A total of 1200 people aged 18 years and older who have completed two or three-dose inactivated COVID-19 vaccine for 6-18 months will be recruited in this study. Subjects will be received 1 dose at day 0 as a booster vaccination.Immunogenicity and safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 will be evaluated.
The study is a randomized, double-blind, positive control design and 1200 subjects are randomly assigned to LYB001 and positive control groups in a 1:1 ratio to evaluate the safety and immunogenicity as a booster vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,200
Intramuscular injection of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in the deltoid muscle of the upper arm at day 0. The inoculation dose is 0.5 mL.
Intramuscular injection of ZF2001 in the deltoid muscle of the upper arm at day 0. The inoculation dose is 0.5 mL.
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China
Geometric neutralizing titers (GMT) of neutralizing antibody against variants of concern(VOCs)
Geometric neutralizing titers (GMT) of neutralizing antibody against variants of concern(VOCs) at day 14 after booster vaccination in cohort 1.
Time frame: Day 14 after booster vaccination
Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs)
Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 14, day 28, month 6 after booster vaccination in cohort 1.
Time frame: Day 14 ,day 28 ,month 6 after vaccination
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 14, day 28, month 6 after booster vaccination in cohort 1.
Time frame: Day 14 ,day 28 ,month 6 after vaccination
Geometric neutralizing titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain
Geometric neutralizing titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain at day 14, day 28, month 6 after booster vaccination in cohort 1.
Time frame: Day 14 ,day 28 ,month 6 after vaccination
GMT of binding antibody against SARS-CoV-2 S protein
GMT of binding antibody against SARS-CoV-2 S protein at day 14, day 28, month 6 after booster vaccination in cohort 1.
Time frame: Day 14 ,day 28 ,month 6 after vaccination
Geometric mean fold rise(GMFR) of binding antibody against SARS-CoV-2 S protein
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Geometric mean fold rise(GMFR) of binding antibody against SARS-CoV-2 S protein at day 14, day 28, month 6 after booster vaccination in cohort 1.
Time frame: Day 14 ,day 28 ,month 6 after vaccination
Seroconversion rate of binding antibody against SARS-CoV-2 S protein
Seroconversion rate of binding antibody against SARS-CoV-2 S protein at day 14, day 28, month 6 after booster vaccination in cohort 1.
Time frame: Day 14 ,day 28 ,month 6 after vaccination
The occurrence of adverse events
The occurrence of adverse events within 30 mins,7 days and 28 days after each vaccinatio
Time frame: 30 mins,7 days and 28 days after vaccination
The occurrence rate of serious adverse events (SAEs) and adverse events of special interest (AESIs)
The occurrence rate of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months after vaccination(28 days after vaccination for positive control group)
Time frame: Day 0 to 12 months after vaccination