This is a randomized, double-blinded, Phase IIb clinical trial of COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate to evaluate the changes in immunogenicity before and after the booster vaccine using the high (1200 SU) or medium (600 SU) dose of COVID-19 Vaccine (Vero Cell), Inactivated.
This is a randomized, double-blinded, Phase IIb clinical trial of 150 participants aged 18 years and above, who have completed two doses of mRNA COVID-19 vaccine as the primary vaccination for at least six months after the second dose. After enrollment, participants will be randomly assigned into two study arms at a ratio of 1:1 to receive a booster of one dose of medium-dose (600 SU) or one dose of high-dose (1200 SU) COVID-19 Vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated: 600SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection
High-dose COVID-19 Vaccine(Vero Cell),Inactivated:1200SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection
Gleneagles Hospital HongKong
Hong Kong, China
Immunogenicity index-Geometric mean fold rise (GMFR) of neutralization antibody titre in the high dose
Geometric mean fold rise (GMFR) of neutralization antibody titre from baseline to 28 days post the booster vaccine in the high dose .
Time frame: 28 days after the booster dose vaccination
Immunogenicity index-Geometric mean fold rise (GMFR) of neutralization antibody titre in the medium dose
Geometric mean fold rise (GMFR) of neutralization antibody titre from baseline to 28 days post the booster vaccine in the medium dose .
Time frame: 28 days after the booster dose vaccination
Immunogenicity index-the seropositivity rate of neutralizing antibody in the high dose
The seropositivity rate of neutralizing antibody on day 28 after the booster dose vaccination in the high dose
Time frame: 28 days after the booster dose vaccination
Immunogenicity index-the seropositivity rate of neutralizing antibody in the medium dose
The seropositivity rate of neutralizing antibody on day 28 after the booster dose vaccination in the high dose
Time frame: 28 days after the booster dose vaccination
Immunogenicity index-Geometric mean of neutralizing antibody titer (GMT) in the medium dose
Geometric mean of neutralizing antibody titer (GMT) on Day 28 after the booster dose vaccination in the high dose
Time frame: 28 days after the booster dose vaccination
Immunogenicity index-Geometric mean of neutralizing antibody titer (GMT)in the medium dose
Geometric mean of neutralizing antibody titer (GMT) on Day 28 after the booster dose vaccination in the medium dose
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Time frame: 28 days after the booster dose vaccination
Immunogenicity index-The seropositivity rate of neutralizing antibody in the high dose
The seropositivity rate of neutralizing antibody at 3 months after the booster dose vaccination in the high dose
Time frame: 3 months after the booster dose vaccination
Immunogenicity index-The seropositivity rate of neutralizing antibody in the medium dose
The seropositivity rate of neutralizing antibody at 3 months after the booster dose vaccination in the medium dose
Time frame: 3 months after the booster dose vaccination
Immunogenicity index-The seropositivity rate in the high dose
The seropositivity rate of neutralizing antibody at 6 months after the booster dose vaccination in the high dose
Time frame: 6 months after the booster dose vaccination
Immunogenicity index-The seropositivity rate in the medium dose
The seropositivity rate of neutralizing antibody at 6 months after the booster dose vaccination in the medium dose
Time frame: 6 months after the booster dose vaccination
Immunogenicity index-GMT of neutralizing antibody in the high dose
GMT of neutralizing antibody at 3 months after the booster dose vaccination in the medium dose
Time frame: 3 months after the booster dose vaccination
Immunogenicity index-the GMT of neutralizing antibody in the high dose
GMT of neutralizing antibody at 6 months after the booster dose vaccination in the medium dose
Time frame: 6 months after the booster dose vaccination
Immunogenicity index-GMT of neutralizing antibody in the medium dose
GMT of neutralizing antibody at 3 months after the booster dose vaccination in the medium dose
Time frame: 3 months after the booster dose vaccination
Immunogenicity index-the GMT of neutralizing antibody in the medium dose
GMT of neutralizing antibody at 6 months after the booster dose vaccination in the medium dose
Time frame: 6 months after the booster dose vaccination
Safety index-Occurrence, intensity, duration, and relationship of solicited local and systemic AEs
Occurrence, intensity, duration, and relationship of solicited local and systemic AEs for seven days following the booster dose vaccination and of unsolicited AEs for 28 days post booster vaccination.
Time frame: 28 days after the booster dose vaccination
Safety index-Occurrence and relationship of SAEs
Occurrence and relationship of SAEs within 12 months post booster vaccination.
Time frame: Within 12 months post booster vaccination
Safety index-Occurrence and relationship of AESI
Occurrence and relationship of AESI within 12 months post booster vaccination.
Time frame: Within 12 months post booster vaccination