{"id":21778,"date":"2022-06-27T04:27:00","date_gmt":"2022-06-26T20:27:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=21778"},"modified":"2022-06-27T05:44:02","modified_gmt":"2022-06-26T21:44:02","slug":"nejm%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e6%a4%8d%e7%89%a9%e6%ba%90%e6%80%a7%e9%87%8d%e7%bb%84%e6%96%b0%e5%86%a0%e7%97%85%e6%af%92%e7%96%ab%e8%8b%97%e7%9a%84%e6%95%88%e6%9e%9c%e4%b8%8e","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=21778","title":{"rendered":"[NEJM\u53d1\u8868\u8bba\u6587]\uff1a\u690d\u7269\u6e90\u6027\u91cd\u7ec4\u65b0\u51a0\u75c5\u6bd2\u75ab\u82d7\u7684\u6548\u679c\u4e0e\u5b89\u5168\u6027"},"content":{"rendered":"\n

ORIGINAL ARTICLE<\/a><\/p>\n\n\n\n

Efficacy and Safety of a Recombinant Plant-Based Adjuvanted Covid-19 Vaccine<\/h1>\n\n\n\n

Karen J. Hager, Gonzalo P\u00e9rez Marc, Philipe Gobeil, et al<\/h3>\n\n\n\n

N Engl J Med May 4, 2022
DOI: 10.1056\/NEJMoa2201300<\/h3>\n\n\n\n

Abstract<\/h2>\n\n\n\n

BACKGROUND<\/h2>\n\n\n\n

Coronavirus-like particles (CoVLP) that are produced in plants and display the prefusion spike glycoprotein of the original strain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are combined with an adjuvant (Adjuvant System 03 [AS03]) to form the candidate vaccine.<\/p>\n\n\n\n

METHODS<\/h2>\n\n\n\n

In this phase 3, multinational, randomized, placebo-controlled trial conducted at 85 centers, we assigned adults (\u226518 years of age) in a 1:1 ratio to receive two intramuscular injections of the CoVLP+AS03 vaccine or placebo 21 days apart. The primary objective of the trial was to determine the efficacy of the CoVLP+AS03 vaccine in preventing symptomatic coronavirus disease 2019 (Covid-19) beginning at least 7 days after the second injection, with the analysis performed after the detection of at least 160 cases.<\/p>\n\n\n\n

RESULTS<\/h2>\n\n\n\n

A total of 24,141 volunteers participated in the trial; the median age of the participants was 29 years. Covid-19 was confirmed by polymerase-chain-reaction assay in 165 participants in the intention-to-treat population; all viral samples that could be sequenced contained variants of the original strain. Vaccine efficacy was 69.5% (95% confidence interval [CI], 56.7 to 78.8) against any symptomatic Covid-19 caused by five variants that were identified by sequencing. In a post hoc analysis, vaccine efficacy was 78.8% (95% CI, 55.8 to 90.8) against moderate-to-severe disease and 74.0% (95% CI, 62.1 to 82.5) among the participants who were seronegative at baseline. No severe cases of Covid-19 occurred in the vaccine group, in which the median viral load for breakthrough cases was lower than that in the placebo group by a factor of more than 100. Solicited adverse events were mostly mild or moderate and transient and were more frequent in the vaccine group than in the placebo group; local adverse events occurred in 92.3% and 45.5% of participants, respectively, and systemic adverse events in 87.3% and 65.0%. The incidence of unsolicited adverse events was similar in the two groups up to 21 days after each dose (22.7% and 20.4%) and from day 43 through day 201 (4.2% and 4.0%).<\/p>\n\n\n\n

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CONCLUSIONS<\/h2>\n\n\n\n

The CoVLP+AS03 vaccine was effective in preventing Covid-19 caused by a spectrum of variants, with efficacy ranging from 69.5% against symptomatic infection to 78.8% against moderate-to-severe disease. (Funded by Medicago; ClinicalTrials.gov number, NCT04636697. opens in new tab<\/a>.)<\/p>\n","protected":false},"excerpt":{"rendered":"

ORIGINAL ARTICLE Efficacy and Safety of a Recombinant P […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21778"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=21778"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21778\/revisions"}],"predecessor-version":[{"id":21779,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21778\/revisions\/21779"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21778"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21778"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21778"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}