This trial adopts a randomized, double-blind and positive control design, it is planned to recruit 1800 healthy participants who have been vaccinated with 2/3 doses of COVID-19 inactivated vaccine or mRNA vaccine for 3 months. The participants will be divided into two strata according to the types of vaccines administered, including 900 participants of COVID-19 inactivated vaccine and 900 participants of mRNA vaccine. According to the ratio of 1:1:1, each stratum was randomly assigned to three groups: sequential BIBP- COVID-19 inactivated vaccine (Omicron), WIBP-COVID-19 inactivated vaccine (Omicron) or COVID-19 inactivated vaccine (prototype strain). And according to D0, D28 immunization schedule, two doses of corresponding group vaccines are sequentially administered.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,804
intramuscular injection in the deltoid muscle
intramuscular injection in the deltoid muscle
intramuscular injection in the deltoid muscle
Queen Mary Hospital
Hong Kong, Hong Kong
The Geometric Mean Titer (GMT) of anti-omicron neutralizing antibody
Time frame: 28 days after sequential vaccination of 2 doses
The 4-fold rise rate of anti-omicron neutralizing antibody
Time frame: 28 days after sequential vaccination of 2 doses
The GMT of anti-omicron neutralizing antibody
Time frame: 14 days after sequential vaccination of 2 doses
The 4-fold rise rate of anti-omicron neutralizing antibody
Time frame: 14 days after sequential vaccination of 2 doses
Specific cellular immune response
Time frame: within 28 days after vaccination
The GMT of anti-omicron Immunoglobulin G (IgG) antibody
Time frame: 28 days after sequential vaccination of 2 doses
The proportions of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64
Time frame: 28 days after sequential vaccination of 2 doses
The proportion of subjects with neutralizing antibody GMT ≥1:16,≥1:32 and ≥1:64
Time frame: on 3rd month, 6th month, 9th month, and 12th month after vaccination
The incidence of any adverse reactions/events
Time frame: 28 days after each immunization
The incidence of serious adverse events (SAE) and adverse events special interest (AESI)
Time frame: from 1st booster dose and up to 6 months following 2nd booster dose
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