{"id":21770,"date":"2022-06-25T04:09:00","date_gmt":"2022-06-24T20:09:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=21770"},"modified":"2022-06-25T04:26:45","modified_gmt":"2022-06-24T20:26:45","slug":"nejm%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e5%9f%ba%e4%ba%8e%e5%8f%97%e4%bd%93%e7%bb%93%e5%90%88%e5%9f%9f%e4%ba%8c%e8%81%9a%e4%bd%93%e7%9a%84%e6%96%b0%e5%86%a0%e7%97%85%e6%af%92%e7%96%ab","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=21770","title":{"rendered":"[NEJM\u53d1\u8868\u8bba\u6587]\uff1a\u57fa\u4e8e\u53d7\u4f53\u7ed3\u5408\u57df\u4e8c\u805a\u4f53\u7684\u65b0\u51a0\u75c5\u6bd2\u75ab\u82d7ZF2001\u5728\u6210\u5e74\u4eba\u7684\u6548\u679c\u548c\u5b89\u5168\u6027"},"content":{"rendered":"\n

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

Efficacy and Safety of the RBD-Dimer\u2013Based Covid-19 Vaccine ZF2001 in Adults<\/h1>\n\n\n\n

Lianpan Dai, Lidong Gao, Lifeng Tao,\u00a0et al<\/h3>\n\n\n\n

N Engl J Med May 4, 2022
DOI: 10.1056\/NEJMoa2202261<\/h3>\n\n\n\n

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

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

The ZF2001 vaccine, which contains a dimeric form of the receptor-binding domain of severe acute respiratory syndrome coronavirus 2 and aluminum hydroxide as an adjuvant, was shown to be safe, with an acceptable side-effect profile, and immunogenic in adults in phase 1 and 2 clinical trials.<\/p>\n\n\n\n

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

We conducted a randomized, double-blind, placebo-controlled, phase 3 trial to investigate the efficacy and confirm the safety of ZF2001. The trial was performed at 31 clinical centers across Uzbekistan, Indonesia, Pakistan, and Ecuador; an additional center in China was included in the safety analysis only. Adult participants (\u226518 years of age) were randomly assigned in a 1:1 ratio to receive a total of three 25-\u03bcg doses (30 days apart) of ZF2001 or placebo. The primary end point was the occurrence of symptomatic coronavirus disease 2019 (Covid-19), as confirmed on polymerase-chain-reaction assay, at least 7 days after receipt of the third dose. A key secondary efficacy end point was the occurrence of severe-to-critical Covid-19 (including Covid-19\u2013related death) at least 7 days after receipt of the third dose.<\/p>\n\n\n\n

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

Between December 12, 2020, and December 15, 2021, a total of 28,873 participants received at least one dose of ZF2001 or placebo and were included in the safety analysis; 25,193 participants who had completed the three-dose regimen, for whom there were approximately 6 months of follow-up data, were included in the updated primary efficacy analysis that was conducted at the second data cutoff date of December 15, 2021. In the updated analysis, primary end-point cases were reported in 158 of 12,625 participants in the ZF2001 group and in 580 of 12,568 participants in the placebo group, for a vaccine efficacy of 75.7% (95% confidence interval [CI], 71.0 to 79.8). Severe-to-critical Covid-19 occurred in 6 participants in the ZF2001 group and in 43 in the placebo group, for a vaccine efficacy of 87.6% (95% CI, 70.6 to 95.7); Covid-19\u2013related death occurred in 2 and 12 participants, respectively, for a vaccine efficacy of 86.5% (95% CI, 38.9 to 98.5). The incidence of adverse events and serious adverse events was balanced in the two groups, and there were no vaccine-related deaths. Most adverse reactions (98.5%) were of grade 1 or 2.<\/p>\n\n\n\n

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

In a large cohort of adults, the ZF2001 vaccine was shown to be safe and effective against symptomatic and severe-to-critical Covid-19 for at least 6 months after full vaccination. (Funded by the National Science and Technology Major Project and others; ClinicalTrials.gov number, NCT04646590. opens in new tab<\/a>.)<\/p>\n","protected":false},"excerpt":{"rendered":"

ORIGINAL ARTICLE Efficacy and Safety of the RBD-Dimer\u2013B […]<\/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\/21770"}],"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=21770"}],"version-history":[{"count":2,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21770\/revisions"}],"predecessor-version":[{"id":22117,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21770\/revisions\/22117"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21770"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21770"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21770"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}