Evidence map›Paper›PMID 34267185›Full record

Trial reportSignal transduction and targeted therapy2021

Safety and immunogenicity of a recombinant COVID-19 vaccine (Sf9 cells) in healthy population aged 18 years or older: two single-center, randomised, double-blind, placebo-controlled, phase 1 and phase 2 trials.

Fan-Yue Meng, Fan Gao, Si-Yue Jia, Xiang-Hong Wu, Jing-Xin Li, Xi-Ling Guo, Jia-Lu Zhang, Bo-Pei Cui, Zhi-Ming Wu, Ming-Wei Wei and 9 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Signal transduction and targeted therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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

23 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Efficacy and safety of COVID-19 vaccines.The Cochrane database of systematic reviews · 2022
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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

19 authors.

Fan-Yue Meng *NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Fan Gao *China National Institute for Food and Drug Control, Beijing, China.
Si-Yue Jia *NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Xiang-Hong WuSheyang County Center for Disease Control and Prevention, Yancheng, China.
Jing-Xin LiNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Xi-Ling GuoNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Jia-Lu ZhangChina National Institute for Food and Drug Control, Beijing, China.
Bo-Pei CuiChina National Institute for Food and Drug Control, Beijing, China.
Zhi-Ming WuJiangdu District Center for Disease Control and Prevention, Yangzhou, China.
Ming-Wei WeiNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Zhi-Long MaTaizhou Center for Disease Control and Prevention, Taizhou, China.
Hai-Lin PengJiangsu Taizhou People's Hospital, Taizhou, China.
Hong-Xing PanNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Lin FanJiangsu Taizhou People's Hospital, Taizhou, China.
Jing ZhangSheyang County Center for Disease Control and Prevention, Yancheng, China.
Jiu-Qin WanJiangdu District Center for Disease Control and Prevention, Yangzhou, China.
Zhong-Kui ZhuTaizhou Center for Disease Control and Prevention, Taizhou, China.
Xue-Wen WangShanghai Canming Medical Technology Co., Ltd, Shanghai, China.
Feng-Cai ZhuNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China. jszfc@vip.sina.com.ORCID 0000-0002-1644-0006

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

COVID-19 vaccines from multiple manufacturers are needed to cope with the problem of insufficient supply. We did two single-center, randomised, double-blind, placebo-controlled phase 1 and phase 2 trials to assess the safety, tolerability and immunogenicity of a recombinant COVID-19 vaccine (Sf9 cells) in healthy population aged 18 years or older in China. Eligible participants were enrolled, the ratio of candidate vaccine and placebo within each dose group was 3:1 (phase 1) or 5:1 (phase 2). From August 28, 2020, 168 participants were sequentially enrolled and randomly assigned to receive the low dose vaccine, high dose vaccine or placebo with the schedule of 0, 28 days or 0, 14, 28 days in phase 1 trial. From November 18, 2020, 960 participants were randomly assigned to receive the low dose vaccine, high dose vaccine or placebo with the schedule of 0, 21 days or 0, 14, 28 days in phase 2 trial. The most common solicited injection site adverse reaction within 7 days in both trials was pain. The most common solicited systematic adverse reactions within 7 days were fatigue, cough, sore throat, fever and headache. ELISA antibodies and neutralising antibodies increased at 14 days, and peaked at 28 days (phase 1) or 30 days (phase 2) after the last dose vaccination. The GMTs of neutralising antibody against live SARS-CoV-2 at 28 days or 30 days after the last dose vaccination were highest in the adult high dose group (0, 14, 28 days), with 102.9 (95% CI 61.9-171.2) and 102.6 (95% CI 75.2-140.1) in phase 1 and phase 2 trials, respectively. Specific T-cell response peaked at 14 days after the last dose vaccination in phase 1 trial. This vaccine is safe, and induced significant immune responses after three doses of vaccination.

Indexed as

COVID-19COVID-19 VaccinesImmunogenicity, VaccineAdolescentAdultFemaleHumansMaleMiddle AgedSARS-CoV-2COVID-19 Vaccines

Identifiers

PMID34267185
PMCPMC8281021

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.