This is a multicenter, parallel groups, partially randomized, open-label, blank-controlled adaptive platform study to evaluate the effectiveness of a second COVID-19 vaccine booster in Chinese adults who are charactered as the majority of whom with hybrid immunity of COVID-19 vaccination and COVID-19 breakthrough infection. Individuals aged 18 years and over, include the elderly over 60 years old or those with underlying diseases (history of underlying medical conditions diagnosed by a clinician, including hypertension, diabetes, heart disease, etc). The eligible participants with an interval ≥ 4 months after previous SARS-CoV-2 infection (or had never been infected) and ≥ 6 months from the first COVID-19 vaccine booster will be recruited. Participants who are not willing to receive the second booster but are consent to participate the surveillance for COVID-19, will be included as a blank control. Informed consent will be acquired from eligible participants. Other participants who are willing to receive the second booster and participate the surveillance for COVID-19, will be randomly allocated in a ratio of 1: k (k is the number of vaccine types) to the different investigational vaccines, stratified according to age and history of COVID-19 infection. The symptomatic COVID-19 cases will be reported and documented in both the investigational and control groups. The occurrence of serious adverse events within 6 months after vaccination will be observed. Moreover, blood and nasal mucosa samples will be collected on the day 0 before and day 14, month 3 and 6 after the booster vaccination in a subgroup for humoral, cellular and mucosal immunogenicity analysis. Moreover, oral specimens will be collected once for all participants on the day of enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
10,000
This vaccine is produced by CanSino Biologics Inc.
This vaccine is produced by CanSino Biologics Inc.
This vaccine is produced by Wantai Biopharmaceutical Company.
This vaccine is produced by CSPC Pharmaceutical Group Co., Ltd.
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China
The incidence of COVID-19 from 14 days to 6 months after the booster immunization.
Time frame: from 14 days to 6 months after the booster dose
The incidence of COVID-19 from 7 days to 6 months after the booster immunization.
Time frame: from 7 days to 6 months the booster dose
The incidence of COVID-19 from 28 days to 6 months after the booster immunization.
Time frame: from 28 days to 6 months the booster dose
The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 7 days to 6 months after the booster immunization.
Time frame: from 7 days to 6 months the booster dose
The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 14 days to 6 months after the booster immunization.
Time frame: from 14 days to 6 months the booster dose
The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 28 days to 6 months after the booster immunization.
Time frame: from 28 days to 6 months the booster dose
The incidence of hospitalized COVID-19 from 7 days to 6 months after the booster immunization.
Time frame: from 7 days to 6 months the booster dose
The incidence of hospitalized COVID-19 from 14 days to 6 months after the booster immunization.
Time frame: from 14 days to 6 months the booster dose
The incidence of hospitalized COVID-19 from 28 days to 6 months after the booster immunization.
Time frame: from 28 days to 6 months the booster dose
Geometric mean titer (GMT), Geometric mean fold increase (GMFI) and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on day 14 after the booster vaccination in the immunogenic subgroup.
Time frame: On day 14 after the booster vaccination
GMT, GMFI and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on month 3 after the booster vaccination in the immunogenic subgroup.
Time frame: On month 3 after the booster vaccination
GMT, GMFI and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on month 6 after the booster vaccination in the immunogenic subgroup.
Time frame: On month 6 after the booster vaccination
GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on day 14 after the booster vaccination in the immunogenic subgroup.
Time frame: On day 14 after the booster vaccination
GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on month 3 after the booster vaccination in the immunogenic subgroup.
Time frame: On month 3 after the booster vaccination
GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on month 6 after the booster vaccination in the immunogenic subgroup.
Time frame: On month 6 after the booster vaccination
GMT, GMFI and seroconversion of nasal specific IgA antibodies on day 14 after the booster vaccination in the immunogenic subgroup.
Time frame: On day 14 after the booster vaccination
GMT, GMFI and seroconversion of nasal specific IgA antibodies on month 3 after the booster vaccination in the immunogenic subgroup.
Time frame: On month 3 after the booster vaccination
GMT, GMFI and seroconversion of nasal specific IgA antibodies on month 6 after the booster vaccination in the immunogenic subgroup.
Time frame: On month 6 after the booster vaccination
The incidence of serious adverse events within 6 months after the booster vaccination.
Time frame: within 6 months after the booster dose
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