Breakthrough SARS-CoV-2 infections during periods of delta and omicron predominance, South Africa.
Breakthrough SARS-CoV-2 infections during periods of delta and omicron predominance, South Africa.
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DOI：
10.1016/s0140-6736(22)01190-4
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发表时间：
2022-07-23
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SARS-CoV-2的欧米克龙变种(B.1.1。529)于2021年11月在南非首次发现。1-3在2021年11月26日宣布了一个令人担忧的变体，4 Omicron以指数形式传播，取代了Delta变体(B.1.617。2)推动新冠肺炎案件快速增长。5、6体外实验表明，在以前感染过SARS-CoV-2或接种过SARS-CoV-2疫苗的人中，Omicron变体可以逃脱抗体中和。7、8流行病学数据表明，奥美康的疫苗效力降低，9再感染率高于贝塔(B.1.351)和德尔塔变种。10在这里，我们描述了南非Sisonke阶段3B AD26的突破性感染--接种疫苗后28天或更长时间的SARS-CoV-2聚合酶链式反应或抗原检测呈阳性。柯萨奇病毒2型。S疫苗试验(NCT04838795)是在Delta和Omicron变种在流通期间进行的。这项试验在南非九个省的360个疫苗接种中心招募了医护人员。研究程序包括电子同意程序、疫苗接种资格现场检查和疫苗接种后安全监测。477 234名卫生保健人员接受了单剂AD26。柯萨奇病毒2型。2021年2月17日至2021年5月17日接种S疫苗；230488名医务人员自愿接种第二剂AD26。柯萨奇病毒2型。S于2021年11月9日至2021年12月16日之间。我们使用代理日期来定义三种SARS-CoV-2变异株在循环中占据主导地位的连续时间段：从2月17日(Sisonke研究开始)到2021年5月17日，用于测试期；从2021年5月18日到11月14日，用于三角洲时期；从2021年11月15日，到2022年1月31日，用于奥米克龙时期。由于2021年2月17日至5月17日是测试期的尾声，我们在此不提供这段时间的详细分析。我们分析了2021年2月17日至2022年1月31日(包括参与者接受第一剂和第二剂AD26的时间)之间的突破性感染模式、与新冠肺炎相关的住院情况(即新冠肺炎检测呈阳性的参与者的住院情况)以及与新冠肺炎相关的死亡情况。柯萨奇病毒2型。S(图)。我们还评估了前78天内突破性感染的频率和严重程度，在此期间，参与者在单剂AD26后主要接触Delta和Omicron变体。柯萨奇病毒2型。S疫苗。人口统计特征和合并症自行报告，疫苗接种员在电子疫苗接种数据系统中记录疫苗接种细节。在整个研究期间，新冠肺炎调查对象的定义保持不变。SARS-CoV-2聚合酶链式反应仍然是诊断的黄金标准；然而，国家认可的抗原检测在2021年10月被引入作为聚合酶链式反应的替代。SARS-CoV-2检测标准在研究期间也保持不变。使用主动和被动监测来监测突破性感染。将Sisonke试验数据与新冠肺炎应通报医疗条件哨兵监测总名单、DATCOV名单(与新冠肺炎相关的住院治疗)和国家人口登记册(由南非医学研究委员会持有)联系起来，以确定参与者是否感染或再感染SARS-CoV-2、与新冠肺炎有关的住院情况以及与新冠肺炎相关的死亡。此外，参与者还收到了短信
The omicron variant of SARS-CoV-2 (B. 1.1. 529) was first detected in South Africa in November, 2021. 1–3 Declared a variant of concern on Nov 26, 2021, 4 omicron spread exponentially, replacing the delta variant (B. 1.617. 2) and driving rapid increases in COVID-19 cases. 5, 6 Invitro experiments show that the omicron variant escapes antibody neutralisation in people who have previously been infected with or vaccinated against SARS-CoV-2. 7, 8 Epidemiological data suggest that vaccine effectiveness is reduced, 9 and reinfection rates are higher for omicron than for the beta (B. 1.351) and delta variants. 10 Here we describe breakthrough infections—positive SARS-CoV-2 PCR or antigen tests 28 days or more after vaccination—in the South African Sisonke phase 3B Ad26. COV2. S vaccine trial (NCT04838795) during periods of time when delta and omicron variants were in circulation. 11 The trial enrolled health-care workers in 360 vaccination centres across South Africa’s nine provinces. Study procedures included an electronic consent process, an on-site check for vaccination eligibility, and post-vaccination safety monitoring. 477 234 health-care workers received a single dose of Ad26. COV2. S vaccine between Feb 17, 2021, and May 17, 2021; 230 488 health-care workers voluntarily received a second dose of Ad26. COV2. S between Nov 9, 2021, and Dec 16, 2021. We used proxy dates to define the contiguous time periods during which each of the three SARS-CoV-2 variants dominated in circulation: from Feb 17 (the start of the Sisonke study) to May 17, 2021, for the beta period; from May 18 to Nov 14, 2021, for the delta period; and from Nov 15, 2021, to Jan 31, 2022, for the omicron period. Since Feb 17–May 17, 2021, was the tail end of the beta period, we do not present the detailed analysis of this period here.We analysed breakthrough infection patterns, COVID-19-related hospitalisations (ie, hospitalisations of participants who tested positive for COVID-19), and COVID-19-related deaths overall between Feb 17, 2021, and Jan 31, 2022—inclusive of when participants received their first and second doses of Ad26. COV2. S (figure). We also evaluated the frequency and severity of breakthrough infections during the first 78 days during which participants were predominantly exposed to the delta and omicron variants after a single dose of the Ad26. COV2. S vaccine. Demographic characteristics and comorbidities were self-reported, and vaccinators recorded vaccination details in the Electronic Vaccination Data System. The definition of a person under investigation for COVID-19 remained constant throughout the study period. SARS-CoV-2 PCR remained the gold standard for diagnosis; however, nationally accredited antigen testing was introduced as an alternative to PCR in October, 2021. Criteria for SARS-CoV-2 testing also remained constant during the study. Breakthrough infections were monitored using active and passive surveillance. Linkage of the Sisonke trial data with the COVID-19 Notifiable Medical Conditions Sentinel Surveillance master list, the DATCOV list (COVID-19-related hospitali sations), and the National Population Register (held by the South African Medical Research Council) identi fied participants with SARS-CoV-2 infections or reinfections, COVID-19-related hospitalisations, and COVID-19-related deaths. Additionally, participants received text messages