[A randomized controlled trial study of immunogenicity and safety of an inactivated SARS-CoV-2 vaccine in different immunization schedules].
Zhonghua Liu Xing Bing Xue Za Zhi
; 42(12): 2077-2081, 2021 Dec 10.
Article
in Chinese
| MEDLINE | ID: covidwho-1600024
ABSTRACT
Objective:
To compare the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine used for the vaccination in public security officers with different immunization schedules.Methods:
From January to February, 2021, 405 public security officers in Taiyuan were randomly divided into 3 groups. Two doses of SARS-CoV-2 inactivated vaccine were injected according to the immunization schedule of 0-14 days, 0-21 days or 0-28 days, respectively. The nucleic acid of SARS-CoV-2 was detected by reverse transcription polymerase chain reaction. The neutralizing antibodies to SARS-CoV-2 were tested by microdose cytopathogenic efficiency assay of live virus. The GMT, seroconversion rate of SARS-CoV-2 neutralizing antibody and safety of the vaccine were analyzed for the 3 groups.Results:
The seroconversion rate of SARS-CoV-2 neutralizing antibody was 100% in all the 3 groups. The SARS-CoV-2 neutralizing antibody level of 0-21 day group [166.70 (95%CI 148.30-185.10)] was similar to that of 0-28 day group [179.50 (95%CI 156.50-202.60)] (P>0.05), significantly higher than that of 0-14 day group [86.08 (95%CI 72.36-99.80)] (P<0.001). The incidence rates of adverse reaction in the 3 groups were 1.48% (2/135), 0.74% (1/136) and 1.49% (2/134) respectively (P=0.750), all the adverse reactions were mild.Conclusions:
The vaccination of inactivated SARS-CoV-2 vaccine with different immunization schedules in public security officers showed good safety and high seroconversion rate, and the GMTs of SARS-CoV-2 neutralizing antibody in 0-21 day group and 0-28 day group were higher than that in 0-14 day group.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
COVID-19 Vaccines
/
COVID-19
Type of study:
Experimental Studies
/
Observational study
/
Randomized controlled trials
Topics:
Vaccines
Limits:
Humans
Language:
Chinese
Journal:
Zhonghua Liu Xing Bing Xue Za Zhi
Year:
2021
Document Type:
Article
Affiliation country:
Cma.j.cn112338-20210807-00617
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