It is a prospective open-labeled study, We intended to recruit the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before, and volunteered to receive the third dose of vaccine (inactivated vaccine, recombinant subunit protein vaccine or mRNA vaccine) into the experimental group, and the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before without a third dose of vaccination plan into the control group. Participants in the experimental group received the third dose of SARS-CoV-2 vaccination at baseline, and participants in the control group received no intervention. Each subject will be followed up for one year after enrollment, and neutralizing antibodies and total antibodies will be tested at the specified time points, as well as the records of adverse events and adverse reactions.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
400
It is a prospective open-labeled study, We intended to recruit the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before, and volunteered to receive the third dose of vaccine (inactivated vaccine, recombinant subunit protein vaccine or mRNA vaccine) into the experimental group, and the participants who completed 2 doses of inactivated COVID-19 vaccine 4-8 months before without a third dose of vaccination plan into the control group. Participants in the experimental group received the third dose of SARS-CoV-2 vaccination at baseline, and participants in the control group received no intervention. Each subject will be followed up for one year after enrollment, and neutralizing antibodies and total antibodies will be tested at the specified time points, as well as the records of adverse events and adverse reactions.
Huashan Hospital affiliated to Fudan University
Shanghai, Jingan, China
Beijing Ditan Hospital Capital Medical University
Beijing, China
Immunogenicity of Third Dose Vaccine Booster Following Two Doses of Inactivated Vaccines
Observe the 28th day of the subjects' pseudovirus neutralizing antibody geometric mean titers (GMTs) and mean geometric titers fold growth (GMFR) changes
Time frame: Day 28
Reactogenicity of Third Dose Vaccine Booster Following Two Doses of Inactivated Vaccines
All solicited and non-solicited adverse events within 28 days.
Time frame: Day 28
The seropositive rate of neutralizing antibodies
The seropositive rate of neutralizing antibodies after third vaccination shots
Time frame: 3 days/14 days/28days/45days/60 days/90 days/180 days/365 days
GMT of neutralizing antibodies
GMT of neutralizing antibodies after third vaccination shots
Time frame: 3 days/14 days/28days/45days/60 days/90 days/180 days/365 days
GMFR of neutralizing antibodies
GMFR of neutralizing antibodies after third vaccination shots
Time frame: 3 days/14 days/28days/45days/60 days/90 days/180 days/365 days
severe adverse events and adverse events of special interest
severe adverse events and adverse events of special interest
Time frame: up to 1 year
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