Trial reportVaccine2021
The safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in Chinese adults aged 18-59 years: A phase I randomized, double-blinded, controlled trial.
Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph
Trial report in Vaccine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04412538 (A Randomized, Double-blind, Placebo-controlled, Phase Ia/IIa Trial of an Inactivated SARS-CoV-2 Vaccine in Healthy People Aged 18 to 59 Years), which is not on this map. Cited by 30 papers, 7 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 7 pooled it
3.4field-weighted citation impact, top 6% of its field
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.
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.
A Randomized, Double-blind, Placebo-controlled, Phase Ia/IIa Trial of an Inactivated SARS-CoV-2 Vaccine in Healthy People Aged 18 to 59 Years
Who cites it
30 citing papers in PubMed, 7 syntheses or guidelines pooled it, 54 citations in OpenAlex.
- Immunogenicity Characterization of COVID-19 Vaccines: A Systematic Review and Meta-analysis.Revista da Sociedade Brasileira de Medicina Tropical · 2023Pooled it
- Assessing the reporting quality of randomized controlled trials on COVID-19 vaccines: a systematic review.Human vaccines & immunotherapeutics · 2022Pooled it
- Efficacy and safety of COVID-19 vaccines.The Cochrane database of systematic reviews · 2022Pooled it
- Global prevalence and clinical manifestations of cutaneous adverse reactions following COVID-19 vaccination: A systematic review and meta-analysis.Journal of the European Academy of Dermatology and Venereology : JEADV · 2022Pooled it
- A systematic review on mucocutaneous presentations after COVID-19 vaccination and expert recommendations about vaccination of important immune-mediated dermatologic disorders.Dermatologic therapy · 2022Pooled it
- Immunogenicity and Safety of the COVID-19 Vaccines Compared With Control in Healthy Adults: A Qualitative and Systematic Review.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2022Pooled it
- Evaluation of the safety profile of COVID-19 vaccines: a rapid review.BMC medicine · 2021Pooled it
- A randomized, observer-blind, phase 1 study of immune responses to three human adenovirus type 26 vector-based vaccines.EBioMedicine · 2026Trial
- Safety and immunogenicity of inactivated SARS-CoV-2 vaccine in high-risk occupational population: a randomized, parallel, controlled clinical trial.Infectious diseases of poverty · 2021Trial
- Safety, tolerability, and immunogenicity of PIKA-adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine in healthy adults: an open-label randomized phase I clinical trial.Clinical and experimental vaccine research · 2024Article
- Article
- Article
- Preclinical immunological evaluation of an intradermal heterologous vaccine against SARS-CoV-2 variants.Emerging microbes & infections · 2022Article
- Identifying COVID-19 optimal vaccine dose using mathematical immunostimulation/immunodynamic modelling.Vaccine · 2022Article
- Variants of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Vaccine Effectiveness.Vaccines · 2022Review
- Immunological Study of Combined Administration of SARS-CoV-2 DNA Vaccine and Inactivated Vaccine.Vaccines · 2022Article
- Immunological evaluation of an mRNA vaccine booster in individuals fully immunized with an inactivated SARS-CoV-2 vaccine.Clinical and translational medicine · 2022Article
- An overview on inactivated and live-attenuated SARS-CoV-2 vaccines.Journal of clinical laboratory analysis · 2022Review
- Reporting and data sharing level for COVID-19 vaccine trials: A cross-sectional study.EBioMedicine · 2022Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
47 authors at 5 institutions in 2 countries.
Jing PuInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Qin YuNational Drug Clinical Trial Institution of West China Second Hospital, Sichuan University, Chengdu 610041, China.
Zhifang YinNational Institute of Food and Drug Control, Beijing 100050, China.
Ying ZhangInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Xueqi LiInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Qiongzhou YinInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Hongbo ChenInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Runxiang LongInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Zhimei ZhaoInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Tangwei MouInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Heng ZhaoInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Shiyin FengNational Drug Clinical Trial Institution of West China Second Hospital, Sichuan University, Chengdu 610041, China.
Zhongping XieInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Lichun WangInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Zhanlong HeInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Yun LiaoInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Shengtao FanInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Ruiju JiangInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Jianfeng WangNational Institute of Food and Drug Control, Beijing 100050, China.
Lingli ZhangNational Drug Clinical Trial Institution of West China Second Hospital, Sichuan University, Chengdu 610041, China.
Jing LiInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Huiwen ZhengInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Pingfang CuiInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Guorun JiangInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Lei GuoInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Mingjue XuInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Huijuan YangInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Shan LuDepartment of Medicine, University of Massachusetts Medical School, Worcester, MA 01655, USA.
Xuanyi WangThe Institutes of Biomedical Science, Shanghai Medical College, Fudan University, Shanghai 200032, China.
Yang GaoInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Xingli XuInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Linrui CaiNational Drug Clinical Trial Institution of West China Second Hospital, Sichuan University, Chengdu 610041, China.
Jian ZhouInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Li YuInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Zhuo ChenNational Drug Clinical Trial Institution of West China Second Hospital, Sichuan University, Chengdu 610041, China.
Chao HongInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Dan DuNational Drug Clinical Trial Institution of West China Second Hospital, Sichuan University, Chengdu 610041, China.
Hongling ZhaoInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Yan LiInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Kaili MaInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Yunfei MaInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Donglan LiuInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Shibao YaoInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China.
Changgui LiNational Institute of Food and Drug Control, Beijing 100050, China. Electronic address: changguili@aliyun.com.
Yanchun CheInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China. Electronic address: cheyanchun@imbcams.com.cn.
Longding LiuInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China. Electronic address: liuld@imbcams.com.cn.
Qihan LiInstitute of Medical Biology, Chinese Academy of Medicine Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development for Severe Infectious Diseases, Kunming 650118, China. Electronic address: liqihan@imbcams.com.cn.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNWest China Second University Hospital of Sichuan University · CNNational Institutes for Food and Drug Control · CNSichuan University · CNUniversity of Massachusetts Chan Medical School · US
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis study examined the safety and immunogenicity of an inactivated SARS-CoV-2 vaccine.
methodIn a phase I randomized, double-blinded, placebo-controlled trial involving 192 healthy adults 18-59 years old, two injections of three doses (50 EU, 100 EU, 150 EU) of an inactivated SARS-CoV-2 vaccine or placebo were administered intramuscularly at a 2- or 4-week interval. The safety and immunogenicity of the vaccine were evaluated.
resultsVaccination was completed in 191 subjects. Forty-four adverse reactions occurred within 28 days, most commonly mild pain and redness at the injection site or slight fatigue. At days 14 and 28, the seroconversion rates were 87.5% and 79.2% (50 EU), 100% and 95.8% (100 EU), and 95.8% and 87.5% (150 EU), respectively, with geometric mean titers (GMTs) of 18.1 and 10.6, 54.5 and 15.4, and 37.1 and 18.5, respectively, for the schedules with 2-week and 4-week intervals. Seroconversion was associated with synchronous upregulation of antibodies against the S protein, N protein and virion and a cytotoxic T lymphocyte (CTL) response. No cytokines and immune cells related to immunopathology were observed. Transcriptome analysis revealed the genetic diversity of immune responses induced by the vaccine.
interpretationIn a population aged 18-59 years in this trial, this inactivated SARS-CoV-2 vaccine was safe and immunogenic.
trial registrationCTR20200943 and NCT04412538.
Indexed as
COVID-19COVID-19 VaccinesVaccinesAdolescentAdultAntibodies, ViralChinaDouble-Blind MethodHumansImmunogenicity, VaccineMiddle AgedSARS-CoV-2Young AdultAntibodies, ViralCOVID-19 VaccinesVaccinesInactivated vaccinePhase ISARS-CoV-2
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Registered trials
NCT04412538ClinicalTrials.gov
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.