Evidence map›Paper›PMID 37325662›Full record

Trial reportFrontiers in immunology2023

Effect of an inactivated coronavirus disease 2019 vaccine, CoronaVac, on blood coagulation and glucose: a randomized, controlled, open-label phase IV clinical trial.

Qing Xu, Xi Lu, Xiaodong Liu, Yanwei Zhao, Dapeng Sun, Qingfan Cao, Haidong Liu, Tuantuan Yang, Yufei Song, Jingjing Lv and 6 more

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase IV
In one paragraph

Trial report in Frontiers in immunology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 2 institutions in 1 country.

Qing XuShandong Provincial Key Laboratory of Infectious Disease Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, Shandong, China.
Xi LuMedical Affairs Department, Sinovac Biotech Co., Ltd., Beijing, China.
Xiaodong LiuShandong Provincial Key Laboratory of Infectious Disease Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, Shandong, China.
Yanwei ZhaoMedical Affairs Department, Sinovac Life Sciences Co., Ltd., Beijing, China.
Dapeng SunShandong Provincial Key Laboratory of Infectious Disease Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, Shandong, China.
Qingfan CaoImmunization Program Department, Rushan City Center for Disease Control and Prevention, Rushan, Shandong, China.
Haidong LiuImmunization Program Department, Rushan City Center for Disease Control and Prevention, Rushan, Shandong, China.
Tuantuan YangMedical Affairs Department, Sinovac Biotech Co., Ltd., Beijing, China.
Yufei SongMedical Affairs Department, Sinovac Biotech Co., Ltd., Beijing, China.
Jingjing LvShandong Provincial Key Laboratory of Infectious Disease Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, Shandong, China.
Ping XiongShandong Provincial Key Laboratory of Infectious Disease Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, Shandong, China.
Jing LiMedical Affairs Department, Sinovac Life Sciences Co., Ltd., Beijing, China.
Jianwen SunMedical Affairs Department, Sinovac Life Sciences Co., Ltd., Beijing, China.
Meng XieShandong Provincial Key Laboratory of Infectious Disease Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, Shandong, China.
Yongjun GaoMedical Affairs Department, Sinovac Biotech Co., Ltd., Beijing, China.
Li ZhangShandong Provincial Key Laboratory of Infectious Disease Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, Shandong, China.
Shandong Center for Disease Control and Prevention · CNSinovac Biotech · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Billions of doses of coronavirus disease 2019 (COVID-19) vaccines have been administered and several cases of thrombocytopenia with thrombosis syndrome (TTS) have been reported after the administration of adenoviral vector vaccines. However, the effects of an inactivated COVID-19 vaccine, CoronaVac, on coagulation are not well understood. Methods: In this randomized, controlled, open-label phase IV clinical trial, 270 participants including 135 adults aged 18-59 years and 135 adults aged 60 years or older, were enrolled and randomized to the CoronaVac group or to the control group in a 2:1 ratio and received two doses of CoronaVac or one dose of the 23-valent pneumococcal polysaccharide vaccine and one dose of inactivated hepatitis A vaccine on days 0 and 28, respectively. Adverse events were collected for 28 days after each dose. Blood samples were taken on days 0, 4, 14, 28, 32, 42, and 56 after the first dose to evaluate neutralizing antibody titers and laboratory parameters of coagulation function and blood glucose. Results: Fourteen days after the second dose of CoronaVac, the seroconversion rates of neutralizing antibodies against the prototype strain and beta, gamma, and delta variants of concern (VOC) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) reached peak values of 89.31%, 23.3%, 45.3%, and 53.5%, respectively. The incidence of adverse reactions was 43.6% and 52.2% in the CoronaVac group and in the control group, respectively. All were mild or moderate in severity. For the laboratory parameters, there was no difference in the means of any parameter between the two groups at any time point, except for the D-dimer on day 14. However, the D-dimer in the CoronaVac group decreased on day 14 compared to the value at baseline, while a higher D-dimer value, instead of a decreased D-dimer value, was a risk factor for TTS. Conclusion: CoronaVac showed a good safety profile and could induce a humoral response against the prototype and VOCs of SARS-CoV-2 in adults 18 years or older, with no abnormal effects on laboratory parameters of blood glucose and coagulation function.

Indexed as

COVID-19GlucoseAdultBlood CoagulationBlood GlucoseCOVID-19 VaccinesHumansSARS-CoV-2Vaccines, InactivatedBlood GlucoseCOVID-19 VaccinesGlucosesinovac COVID-19 vaccineVaccines, Inactivatedblood coagulationblood glucoseCoronaVacCOVID-19 vaccinesSARS-CoV-2thrombosis with thrombocytopenia syndrome (TTS)

Identifiers

PMID37325662
PMCPMC10265469
OpenAlexW4378906130

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.