A total of 516 healthy subjects aged 18 years and above who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine, will be enrolled, and randomly assigned to experimental group and control group in a 1:1 ratio, with 258 subjects in each sequential group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
516
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-09) in the deltoid muscle of the upper arm
Biological/Vaccine: Inactivated COVID-19 vaccine (Vero cells) Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm
Sheikh Khalifa Medical City
SEHA, Abu Dhab, United Arab Emirates
GMT (Omicron) of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age
Time frame: 14 days after sequential immunization of one booster dose
the 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age
Time frame: 14 days after a single dose of the booster vaccine
The incidence rate of any adverse reactions/events
Time frame: within 30 minutes after vaccination
The incidence severity of any adverse reactions/events
Time frame: within 30 minutes after vaccination
The incidence rate of solicited adverse reactions/events
Time frame: within 0-7 days after vaccination
The incidence severity of solicited adverse reactions/events
Time frame: within 0-7 days after vaccination
The incidence rate of solicited adverse reactions/events
Time frame: within 8-30 days after vaccination
The incidence severity of solicited adverse reactions/events
Time frame: within 8-30 days after immunization
The incidence of SAE observed
Time frame: up to 12 months after full course of immunization
The incidence of AESI observed
Time frame: up to 12 months after full course of immunization
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4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age
Time frame: 28 days after sequential immunization of one booster dose
GMT of anti-omicron neutralizing antibody in adults ≥18 years of age
Time frame: 28 days after sequential immunization of one booster dose
4-fold rise rate of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age
Time frame: 28 days after sequential immunization of one booster dose
GMT of anti-omicron IgG antibody in adults ≥18 years of age
Time frame: before booster vaccination and 28 days after a single dose of the booster vaccine
4-fold rise rate of anti-omicron IgG antibody in adults ≥18 years of age
Time frame: before booster vaccination and 28 days after a single dose of the booster vaccine
proportions of neutralizing antibody tittered 1: 16, 1: 32 and 1: 64 of anti-SARS-CoV-2 IgG antibody in adults ≥18 years of age
Time frame: before booster vaccination and 28 days after a single dose of the booster vaccine
GMI of anti-omicron IgG antibody in adults ≥18 years of age
Time frame: before booster vaccination and 28 days after a single dose of the booster vaccine
GMTs of anti-omicron neutralizing antibody
Time frame: 3 months, 6 months, 9 months and 12 months after sequential immunization
IgG antibody of anti-omicron neutralizing antibody
Time frame: 3 months, 6 months, 9 months and 12 months after sequential immunization
the proportions of neutralizing antibody titered 1: 16, 1: 32 and 1: 64
Time frame: 3 months, 6 months, 9 months and 12 months after sequential immunization