A randomized controlled trial study of immunogenicity and safety of an inactivated SARS-CoV-2 vaccine in different immunization schedules
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2021 |
|---|---|
| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:42 |
|---|---|
| Enthalten in: |
Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi - 42(2021), 12 vom: 10. Dez., Seite 2077-2081 |
| Sprache: |
Chinesisch |
|---|
| Beteiligte Personen: |
Chen, J [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Antibodies, Neutralizing |
|---|
| Anmerkungen: |
Date Completed 28.12.2021 Date Revised 28.12.2021 published: Print Citation Status MEDLINE |
|---|
| doi: |
10.3760/cma.j.cn112338-20210807-00617 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM334908590 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM334908590 | ||
| 003 | DE-627 | ||
| 005 | 20231225224714.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2021 xx |||||o 00| ||chi c | ||
| 024 | 7 | |a 10.3760/cma.j.cn112338-20210807-00617 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1116.xml |
| 035 | |a (DE-627)NLM334908590 | ||
| 035 | |a (NLM)34954967 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a chi | ||
| 100 | 1 | |a Chen, J |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A randomized controlled trial study of immunogenicity and safety of an inactivated SARS-CoV-2 vaccine in different immunization schedules |
| 264 | 1 | |c 2021 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 28.12.2021 | ||
| 500 | |a Date Revised 28.12.2021 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 7 | |a Antibodies, Neutralizing |2 NLM | |
| 650 | 7 | |a Antibodies, Viral |2 NLM | |
| 650 | 7 | |a COVID-19 Vaccines |2 NLM | |
| 650 | 7 | |a SARS-CoV-2 inactivated vaccines |2 NLM | |
| 650 | 7 | |a Vaccines, Inactivated |2 NLM | |
| 700 | 1 | |a Li, X Q |e verfasserin |4 aut | |
| 700 | 1 | |a Lu, X X |e verfasserin |4 aut | |
| 700 | 1 | |a Xing, R Q |e verfasserin |4 aut | |
| 700 | 1 | |a Li, H |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, X H |e verfasserin |4 aut | |
| 700 | 1 | |a Wei, Z Y |e verfasserin |4 aut | |
| 700 | 1 | |a Mu, S C |e verfasserin |4 aut | |
| 700 | 1 | |a Feng, L Z |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, S P |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi |d 1993 |g 42(2021), 12 vom: 10. Dez., Seite 2077-2081 |w (DE-627)NLM012811793 |x 0254-6450 |7 nnns |
| 773 | 1 | 8 | |g volume:42 |g year:2021 |g number:12 |g day:10 |g month:12 |g pages:2077-2081 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.3760/cma.j.cn112338-20210807-00617 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 42 |j 2021 |e 12 |b 10 |c 12 |h 2077-2081 | ||