PMID- 36441137
OWN - NLM
STAT- MEDLINE
DCOM- 20221216
LR  - 20221221
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 18
IP  - 6
DP  - 2022 Nov 30
TI  - Lot-to-lot consistency, immunogenicity, and safety of an inactivated SARS-CoV-2 
      vaccine (CoronaVac) in healthy adults: A randomized, double-blind, phase IV 
      trial.
PG  - 2135929
LID - 10.1080/21645515.2022.2135929 [doi]
LID - 2135929
AB  - Previous phase I to III clinical trials have shown that the inactivated 
      SARS-CoV-2 vaccine namely CoronaVac has good efficacy, safety, and 
      immunogenicity. This phase IV trial aims to evaluate the lot-to-lot consistency, 
      immunogenicity, and safety on a commercial scale in healthy adults, which could 
      provide data to support stable manufacturing. In this single-center, randomized, 
      double-blind study, 1,080 healthy adults aged 26-45 years were randomly assigned 
      into three groups to receive one of three lots of vaccines. All subjects received 
      two doses of CoronaVac with an interval of 28 days. Serum samples were collected 
      before the first dose and 28 days after the second dose to assess the 
      immunogenicity. Solicited local and systemic adverse events (AEs) within 7 days 
      and unsolicited AEs within 28 days after each dose of vaccination were recorded. 
      A total of 1,039 participants completed the study and were included in the 
      per-protocol set (PPS). The GMTs were 75.2 (68.5,82.6), 65.0 (59.0,71.7), and 
      65.3 (59.4,71.8), respectively, and the seroconversion rates of neutralizing 
      antibody were all higher than 98%. The GMT ratios of each pair of lots were 1.16 
      (1.01,1.32), 1.15 (1.01, 1.32), and 0.99 (0.87, 1.14), respectively, meeting the 
      immunological equivalence criteria. The incidence rates of adverse reactions 
      (ARs) were 19.17%, 13.89%, and 18.33%, with no statistical difference. The ARs 
      were all in grade 1 and grade 2, with incidences of 15.46% and 2.50%. 
      Non-vaccine-related serious adverse events (SAEs) were reported. These results 
      showed robust lot-to-lot consistency, immunogenicity, and safety. The stable 
      production indicated that CoronaVac is suitable for large-scale use.Trial 
      registration number: NCT04894227 (ClinicalTrials.gov).
FAU - Zhu, Dandan
AU  - Zhu D
AD  - Huaiyin District Center for Disease Control and Prevention, Huai'an, China.
FAU - Hu, Yuansheng
AU  - Hu Y
AD  - Clinical Research and Development Center, Sinovac Biotech, Beijing, China.
FAU - Jiang, Zhiwei
AU  - Jiang Z
AD  - Beijing Key-Tech Statistical Consulting Co, Ltd, Beijing, China.
FAU - Yang, Tuantuan
AU  - Yang T
AD  - Clinical Research and Development Center, Sinovac Biotech, Beijing, China.
FAU - Chu, Kai
AU  - Chu K
AD  - Jiangsu Provincial Center for Disease Control and Prevention, Institution of 
      Vaccine Clinical Trials, Nanjing, China.
FAU - Zhang, Hengming
AU  - Zhang H
AD  - Clinical Research and Development Center, Sinovac Biotech, Beijing, China.
FAU - Hu, Jialei
AU  - Hu J
AD  - Jiangsu Provincial Center for Disease Control and Prevention, Institution of 
      Vaccine Clinical Trials, Nanjing, China.
FAU - Meng, Xing
AU  - Meng X
AD  - Clinical Research and Development Center, Sinovac Biotech, Beijing, China.
FAU - Tan, Zhijun
AU  - Tan Z
AD  - Beijing Key-Tech Statistical Consulting Co, Ltd, Beijing, China.
FAU - Wu, Jingliang
AU  - Wu J
AD  - Huaiyin District Center for Disease Control and Prevention, Huai'an, China.
FAU - Lian, Xiaojuan
AU  - Lian X
AD  - Sinovac Life Science, Beijing, China.
FAU - Li, Changgui
AU  - Li C
AD  - National Institutes for Food and Drug Control, Control of Biological Products, 
      Beijing, China.
FAU - Pan, Hongxing
AU  - Pan H
AD  - Jiangsu Provincial Center for Disease Control and Prevention, Institution of 
      Vaccine Clinical Trials, Nanjing, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT04894227
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20221128
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (sinovac COVID-19 vaccine)
RN  - 0 (COVID-19 Vaccines)
RN  - 0 (Vaccines, Inactivated)
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
SB  - IM
MH  - Adult
MH  - Humans
MH  - *COVID-19 Vaccines/adverse effects
MH  - Double-Blind Method
MH  - SARS-CoV-2
MH  - *COVID-19/prevention & control
MH  - Vaccines, Inactivated/adverse effects
MH  - Antibodies, Neutralizing
MH  - Immunogenicity, Vaccine
MH  - Antibodies, Viral
PMC - PMC9746504
OTO - NOTNLM
OT  - CoronaVac
OT  - Lot-to-lot consistency
OT  - SARS-CoV-2
OT  - immunogenicity
OT  - safety
COIS- Yuansheng Hu, Tuantuan Yang, Hengming Zhang, and Xing Meng are employees of 
      Sinovac Biotech Co., Ltd. Xiaojuan Lian is an employee of Sinovac Life Sciences 
      Co., Ltd. All the other authors have no conflicts of interest to declare.
EDAT- 2022/11/29 06:00
MHDA- 2022/12/15 06:00
PMCR- 2022/11/28
CRDT- 2022/11/28 10:47
PHST- 2022/11/29 06:00 [pubmed]
PHST- 2022/12/15 06:00 [medline]
PHST- 2022/11/28 10:47 [entrez]
PHST- 2022/11/28 00:00 [pmc-release]
AID - 2135929 [pii]
AID - 10.1080/21645515.2022.2135929 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2022 Nov 30;18(6):2135929. doi: 
      10.1080/21645515.2022.2135929. Epub 2022 Nov 28.