Effectiveness of the Ad26.COV2.S vaccine in health-care workers in South Africa (the Sisonke study): results from a single-arm, open-label, phase 3B, implementation study.
Effectiveness of the Ad26.COV2.S vaccine in health-care workers in South Africa (the Sisonke study): results from a single-arm, open-label, phase 3B, implementation study.
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DOI：
10.1016/s0140-6736(22)00007-1
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发表时间：
2022-03-19
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影响因子：
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通讯作者：
Sisonke Study Team
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作者：
Bekker LG;Garrett N;Goga A;Fairall L;Reddy T;Yende-Zuma N;Kassanjee R;Collie S;Sanne I;Boulle A;Seocharan I;Engelbrecht I;Davies MA;Champion J;Chen T;Bennett S;Mametja S;Semenya M;Moultrie H;de Oliveira T;Lessells RJ;Cohen C;Jassat W;Groome M;Von Gottberg A;Le Roux E;Khuto K;Barouch D;Mahomed H;Wolmarans M;Rousseau P;Bradshaw D;Mulder M;Opie J;Louw V;Jacobson B;Rowji P;Peter JG;Takalani A;Odhiambo J;Mayat F;Takuva S;Corey L;Gray GE;Sisonke Protocol Team;Sisonke Study Team
我们的目的是评估在南非 COVID-19 疫情的两波疫情期间，单剂 Ad26.COV2.S 疫苗（强生公司）对南非医护人员的有效性。在单臂、开放标签、3B 期实施的 Sisonke 研究中，18 岁及以上的卫生保健工作者被邀请在全国 122 个疫苗接种点之一进行疫苗接种。参与者接受了单剂 5 × 1010 个病毒颗粒的 Ad26.COV2.S 疫苗。已接种疫苗的参与者与两个国家医疗保险计划（计划 A 和计划 B）之一的个人数据相关联，并与普通人群中未接种疫苗的成员进行 COVID-19 风险匹配。主要结局是疫苗对重症 COVID-19 的有效性，定义为医护人员与普通人群相比，与 COVID-19 相关的入院、需要重症监护或重症监护的住院治疗或死亡，在疫苗接种或匹配后 28 天或更长时间内确定，直至数据截止。该研究已在南非国家临床试验注册中心 (DOH-27-022021-6844)、ClinicalTrials.gov (NCT04838795) 和泛非临床试验注册中心 (PACTR202102855526180) 注册，并已停止应计。 2021年2月17日至5月17日期间，共有477 102名卫生保健工作者入组并接种疫苗，其中357 401名（74·9%）为女性，119 701名（25·1%）为男性，中位年龄为42·0岁（33·0–51·0）。 215 813 名已接种疫苗的个体与 215 813 名未接种疫苗的个体进行了匹配。截至数据截止（2021 年 7 月 17 日），来自总匹配队列的疫苗预防与 COVID-19 相关的死亡的有效性为 83%（95% CI 75-89），预防与 COVID-19 相关的需要重症监护或重症监护的住院率为 75%（69-82），预防与 COVID-19 相关的住院治疗的有效性为 67%（62-71）。方案 A 和方案 B 的所有三种结局的疫苗有效性均一致。对于老年卫生保健工作者和患有艾滋病毒感染等合并症的人，疫苗有效性得以维持。在研究过程中，所关注的 SARS-CoV-2 变体 β (B.1.351) 和 Delta (B.1.617.2) 占主导地位，疫苗有效性保持一致（方案 A 加 B 疫苗在 β 波期间针对 COVID-19 相关入院的有效性为 62% [95% CI 42-76]，在 delta 波期间为 67% [62-71]，疫苗针对与 COVID-19 相关的死亡的有效性β 波期间为 86% [57–100]，δ 波期间为 82% [74–89]）。单剂量 Ad26.COV2.S 疫苗显示出对严重 COVID-19 疾病和接种疫苗后与 COVID-19 相关的死亡以及针对 β 和 δ 变体的有效性，为其在全球范围内的使用提供了真实世界的证据。南非国家财政部、国家卫生部、团结应对基金 NPC、迈克尔和苏珊戴尔基金会、埃尔玛疫苗和免疫基金会以及比尔和梅琳达盖茨基金会。
We aimed to assess the effectiveness of a single dose of the Ad26.COV2.S vaccine (Johnson & Johnson) in health-care workers in South Africa during two waves of the South African COVID-19 epidemic. In the single-arm, open-label, phase 3B implementation Sisonke study, health-care workers aged 18 years and older were invited for vaccination at one of 122 vaccination sites nationally. Participants received a single dose of 5 × 1010 viral particles of the Ad26.COV2.S vaccine. Vaccinated participants were linked with their person-level data from one of two national medical insurance schemes (scheme A and scheme B) and matched for COVID-19 risk with an unvaccinated member of the general population. The primary outcome was vaccine effectiveness against severe COVID-19, defined as COVID-19-related admission to hospital, hospitalisation requiring critical or intensive care, or death, in health-care workers compared with the general population, ascertained 28 days or more after vaccination or matching, up to data cutoff. This study is registered with the South African National Clinical Trial Registry, DOH-27-022021-6844, ClinicalTrials.gov, NCT04838795, and the Pan African Clinical Trials Registry, PACTR202102855526180, and is closed to accrual. Between Feb 17 and May 17, 2021, 477 102 health-care workers were enrolled and vaccinated, of whom 357 401 (74·9%) were female and 119 701 (25·1%) were male, with a median age of 42·0 years (33·0–51·0). 215 813 vaccinated individuals were matched with 215 813 unvaccinated individuals. As of data cutoff (July 17, 2021), vaccine effectiveness derived from the total matched cohort was 83% (95% CI 75–89) to prevent COVID-19-related deaths, 75% (69–82) to prevent COVID-19-related hospital admissions requiring critical or intensive care, and 67% (62–71) to prevent COVID-19-related hospitalisations. The vaccine effectiveness for all three outcomes were consistent across scheme A and scheme B. The vaccine effectiveness was maintained in older health-care workers and those with comorbidities including HIV infection. During the course of the study, the beta (B.1.351) and then the delta (B.1.617.2) SARS-CoV-2 variants of concerns were dominant, and vaccine effectiveness remained consistent (for scheme A plus B vaccine effectiveness against COVID-19-related hospital admission during beta wave was 62% [95% CI 42–76] and during delta wave was 67% [62–71], and vaccine effectiveness against COVID-19-related death during beta wave was 86% [57–100] and during delta wave was 82% [74–89]). The single-dose Ad26.COV2.S vaccine shows effectiveness against severe COVID-19 disease and COVID-19-related death after vaccination, and against both beta and delta variants, providing real-world evidence for its use globally. National Treasury of South Africa, the National Department of Health, Solidarity Response Fund NPC, The Michael & Susan Dell Foundation, The Elma Vaccines and Immunization Foundation, and the Bill & Melinda Gates Foundation.