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《Lancet，5月22日，Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial》

  • 来源专题：COVID-19科研动态监测
  • 编译者： zhangmin
  • 发布时间：2020-05-23

  • Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial

    Prof Feng-Cai Zhu, MSc †

    Prof Yu-Hua Li, PhD †

    Prof Xu-Hua Guan, PhD

    Prof Li-Hua Hou, PhD

    Wen-Juan Wang, MSc

    Prof Jing-Xin Li, PhD

    et al.

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    Published:May 22, 2020DOI:https://doi.org/10.1016/S0140-6736(20)31208-3

    Summary

    Background

    A vaccine to protect against COVID-19 is urgently needed. We aimed to assess the safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 (Ad5) vectored COVID-19 vaccine expressing the spike glycoprotein of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain.

    Methods

    We did a dose-escalation, single-centre, open-label, non-randomised, phase 1 trial of an Ad5 vectored COVID-19 vaccine in Wuhan, China. Healthy adults aged between 18 and 60 years were sequentially enrolled and allocated to one of three dose groups (5?×?1010, 1?×?1011, and 1·5?×?1011 viral particles) to receive an intramuscular injection of vaccine. The primary outcome was adverse events in the 7 days post-vaccination. Safety was assessed over 28 days post-vaccination. Specific antibodies were measured with ELISA, and the neutralising antibody responses induced by vaccination were detected with SARS-CoV-2 virus neutralisation and pseudovirus neutralisation tests. T-cell responses were assessed by enzyme-linked immunospot and flow-cytometry assays. This study is registered with ClinicalTrials.gov, NCT04313127.

  • 原文来源：https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31208-3/fulltext
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