{"id":20298,"date":"2021-05-30T05:43:00","date_gmt":"2021-05-29T21:43:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=20298"},"modified":"2021-06-03T05:35:32","modified_gmt":"2021-06-02T21:35:32","slug":"jama%e5%9c%a8%e7%ba%bf%e5%8f%91%e8%a1%a8%ef%bc%9a2%e7%a7%8d%e7%81%ad%e6%b4%bb%e6%96%b0%e5%86%a0%e7%97%85%e6%af%92%e7%96%ab%e8%8b%97%ef%bc%88%e5%9b%bd%e8%8d%af%e7%96%ab%e8%8b%97%ef%bc%89%e5%af%b9","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=20298","title":{"rendered":"[JAMA\u5728\u7ebf\u53d1\u8868]\uff1a2\u79cd\u706d\u6d3b\u65b0\u51a0\u75c5\u6bd2\u75ab\u82d7\uff08\u56fd\u836f\u75ab\u82d7\uff09\u5bf9\u6210\u5e74\u4eba\u6709\u75c7\u72b6\u65b0\u51a0\u75c5\u6bd2\u611f\u67d3\u7684\u6548\u679c"},"content":{"rendered":"\n

Original Investigation May 26, 2021<\/p>\n\n\n\n

Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial<\/h1>\n\n\n\n

Nawal\u00a0Al Kaabi,\u00a0Yuntao\u00a0Zhang,\u00a0Shengli\u00a0Xia,\u00a0et al<\/h3>\n\n\n\n

JAMA.\u00a0<\/em>Published online May 26, 2021. doi:10.1001\/jama.2021.8565<\/h3>\n\n\n\n

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

Importance<\/strong><\/h3>\n\n\n\n

Although effective vaccines against COVID-19 have been developed, additional vaccines are still needed.<\/p>\n\n\n\n

Objective<\/strong><\/h3>\n\n\n\n

To evaluate the efficacy and adverse events of 2 inactivated COVID-19 vaccines.<\/p>\n\n\n\n

Design, Setting, and Participants<\/strong><\/h3>\n\n\n\n

Prespecified interim analysis of an ongoing randomized, double-blind, phase 3 trial in the United Arab Emirates and Bahrain among adults 18 years and older without known history of COVID-19. Study enrollment began on July 16, 2020. Data sets used for the interim analysis of efficacy and adverse events were locked on December 20, 2020, and December 31, 2020, respectively.<\/p>\n\n\n\n

Interventions<\/strong><\/h3>\n\n\n\n

Participants were randomized to receive 1 of 2 inactivated vaccines developed from SARS-CoV-2 WIV04 (5 \u00b5g\/dose; n\u2009=\u200913 459) and HB02 (4 \u00b5g\/dose; n\u2009=\u200913 465) strains or an aluminum hydroxide (alum)\u2013only control (n\u2009=\u200913 458); they received 2 intramuscular injections 21 days apart.<\/p>\n\n\n\n

Main Outcomes and Measures<\/strong><\/h3>\n\n\n\n

The primary outcome was efficacy against laboratory-confirmed symptomatic COVID-19 14 days following a second vaccine dose among participants who had no virologic evidence of SARS-CoV-2 infection at randomization. The secondary outcome was efficacy against severe COVID-19. Incidence of adverse events and reactions was collected among participants who received at least 1 dose.<\/p>\n\n\n\n

Results<\/strong><\/h3>\n\n\n\n

Among 40 382 participants randomized to receive at least 1 dose of the 2 vaccines or alum-only control (mean age, 36.1 years; 32 261 [84.4%] men), 38 206 (94.6%) who received 2 doses, contributed at least 1 follow-up measure after day 14 following the second dose, and had negative reverse transcriptase\u2013polymerase chain reaction test results at enrollment were included in the primary efficacy analysis. During a median (range) follow-up duration of 77 (1-121) days, symptomatic COVID-19 was identified in 26 participants in the WIV04 group (12.1 [95% CI, 8.3-17.8] per 1000 person-years), 21 in the HB02 group (9.8 [95% CI, 6.4-15.0] per 1000 person-years), and 95 in the alum-only group (44.7 [95% CI, 36.6-54.6] per 1000 person-years), resulting in a vaccine efficacy, compared with alum-only, of 72.8% (95% CI, 58.1%-82.4%) for WIV04 and 78.1% (95% CI, 64.8%-86.3%) for HB02 (P<\/em>\u2009<\u2009.001 for both). Two severe cases of COVID-19 occurred in the alum-only group and none occurred in the vaccine groups. Adverse reactions 7 days after each injection occurred in 41.7% to 46.5% of participants in the 3 groups; serious adverse events were rare and similar in the 3 groups (WIV04: 64 [0.5%]; HB02: 59 [0.4%]; alum-only: 78 [0.6%]).<\/p>\n\n\n\n

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Conclusions and Relevance<\/strong><\/h3>\n\n\n\n

In this prespecified interim analysis of a randomized clinical trial, treatment of adults with either of 2 inactivated SARS-CoV-2 vaccines significantly reduced the risk of symptomatic COVID-19, and serious adverse events were rare. Data collection for final analysis is pending.<\/p>\n\n\n\n

Trial Registration<\/strong><\/h3>\n\n\n\n

ClinicalTrials.gov Identifier:\u00a0NCT04510207<\/a>; Chinese Clinical Trial Registry:\u00a0ChiCTR2000034780<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Original Investigation May 26, 2021 Effe […]<\/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\/20298"}],"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=20298"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/20298\/revisions"}],"predecessor-version":[{"id":20299,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/20298\/revisions\/20299"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=20298"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20298"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20298"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}