{"id":18952,"date":"2020-05-29T04:56:24","date_gmt":"2020-05-28T20:56:24","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=18952"},"modified":"2020-07-14T16:15:09","modified_gmt":"2020-07-14T08:15:09","slug":"lancet%e5%9c%a8%e7%ba%bf%e5%8f%91%e8%a1%a8%ef%bc%9a%e9%87%8d%e7%bb%845%e5%9e%8b%e8%85%ba%e7%97%85%e6%af%92%e4%b8%ba%e8%bd%bd%e4%bd%93%e7%9a%84%e6%96%b0%e5%86%a0%e7%97%85%e6%af%92%e7%96%ab%e8%8b%97","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=18952","title":{"rendered":"[Lancet\u5728\u7ebf\u53d1\u8868]\uff1a\u91cd\u7ec45\u578b\u817a\u75c5\u6bd2\u4e3a\u8f7d\u4f53\u7684\u65b0\u51a0\u75c5\u6bd2\u75ab\u82d7\u7684\u5b89\u5168\u6027\u3001\u8010\u53d7\u6027\u548c\u514d\u75ab\u539f\u6027"},"content":{"rendered":"\n

ARTICLES|ONLINE FIRST<\/a><\/p>\n\n\n\n

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<\/h1>\n\n\n\n

Feng-Cai Zhu, Yu-Hua Li, Xu-Hua Guan,\u00a0et al<\/h3>\n\n\n\n

Lancet Published:May 22, 2020 DOI: https:\/\/doi.org\/10.1016\/S0140-6736(20)31208-3<\/a><\/h3>\n\n\n\n

Summary<\/h2>\n\n\n\n

Background<\/h3>\n\n\n\n

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.<\/p>\n\n\n\n

Methods<\/h3>\n\n\n\n

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\u2008\u00d7\u20081010<\/sup>, 1\u2008\u00d7\u20081011<\/sup>, and 1\u00b75\u2008\u00d7\u20081011<\/sup> 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<\/a>, NCT04313127<\/a>.<\/p>\n\n\n\n

Findings<\/h3>\n\n\n\n

Between March 16 and March 27, 2020, we screened 195 individuals for eligibility. Of them, 108 participants (51% male, 49% female; mean age 36\u00b73 years) were recruited and received the low dose (n=36), middle dose (n=36), or high dose (n=36) of the vaccine. All enrolled participants were included in the analysis. At least one adverse reaction within the first 7 days after the vaccination was reported in 30 (83%) participants in the low dose group, 30 (83%) participants in the middle dose group, and 27 (75%) participants in the high dose group. The most common injection site adverse reaction was pain, which was reported in 58 (54%) vaccine recipients, and the most commonly reported systematic adverse reactions were fever (50 [46%]), fatigue (47 [44%]), headache (42 [39%]), and muscle pain (18 [17%]. Most adverse reactions that were reported in all dose groups were mild or moderate in severity. No serious adverse event was noted within 28 days post-vaccination. ELISA antibodies and neutralising antibodies increased significantly at day 14, and peaked 28 days post-vaccination. Specific T-cell response peaked at day 14 post-vaccination.<\/p>\n\n\n\n

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Interpretation<\/h3>\n\n\n\n

The Ad5 vectored COVID-19 vaccine is tolerable and immunogenic at 28 days post-vaccination. Humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults, and rapid specific T-cell responses were noted from day 14 post-vaccination. Our findings suggest that the Ad5 vectored COVID-19 vaccine warrants further investigation.<\/p>\n\n\n\n

Funding<\/h3>\n\n\n\n

National Key R&D Program of China, National Science and Technology Major Project, and CanSino Biologics.<\/p>\n","protected":false},"excerpt":{"rendered":"

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