Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant.
Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant.
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DOI：
10.1056/nejmoa2102214
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发表时间：
2021-05-20
期刊：
影响因子：
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通讯作者：
Wits-VIDA COVID Group
中科院分区：
文献类型：
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作者：
Madhi SA;Baillie V;Cutland CL;Voysey M;Koen AL;Fairlie L;Padayachee SD;Dheda K;Barnabas SL;Bhorat QE;Briner C;Kwatra G;Ahmed K;Aley P;Bhikha S;Bhiman JN;Bhorat AE;du Plessis J;Esmail A;Groenewald M;Horne E;Hwa SH;Jose A;Lambe T;Laubscher M;Malahleha M;Masenya M;Masilela M;McKenzie S;Molapo K;Moultrie A;Oelofse S;Patel F;Pillay S;Rhead S;Rodel H;Rossouw L;Taoushanis C;Tegally H;Thombrayil A;van Eck S;Wibmer CK;Durham NM;Kelly EJ;Villafana TL;Gilbert S;Pollard AJ;de Oliveira T;Moore PL;Sigal A;Izu A;NGS-SA Group;Wits-VIDA COVID Group
评估针对严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）的疫苗在不同人群中的安全性和有效性至关重要，调查针对新出现的令人关注的SARS-CoV-2变体(包括首次在南非发现的B.1.351 （501Y.V2）变体的疫苗的有效性也至关重要。我们在南非进行了一项多中心、双盲、随机对照试验，以评估ChAdOx1 nCoV-19疫苗（AZD1222）在未感染人类免疫缺陷病毒（HIV）的人群中的安全性和有效性。年龄在18岁至65岁以下的参与者按1:1的比例接受两剂含有5×1010病毒颗粒或安慰剂（0.9%氯化钠溶液）的疫苗，间隔21至35天。采用假病毒和活病毒中和试验对25名参与者在第二次给药后获得的血清样本进行了对原始D614G病毒和B.1.351变体的中和试验。主要终点是疫苗在第二次接种后14天以上对实验室确认的有症状的2019冠状病毒疾病（Covid-19）的安全性和有效性。在2020年6月24日至11月9日期间，我们招募了2026名艾滋病毒阴性成人（年龄中位数为30岁）；1010名和1011名参与者分别接受了至少一剂安慰剂或疫苗。假病毒中和试验和活病毒中和试验均显示，从疫苗接种者获得的血清样本比安慰剂接种者获得的样本对B.1.351变异体的抵抗力更强。在主要终点分析中，717名安慰剂接受者中有23名（3.2%）和750名疫苗接受者中有19名（2.5%）出现轻至中度Covid-19，疗效为21.9%（95%可信区间[CI]， - 49.9至59.8）。42例新冠肺炎患者中，39例（92.9%）由B.1.351变异引起；作为次要终点分析，疫苗对该变异的有效性为10.4% （95% CI,−76.8至54.8）。严重不良事件的发生率在疫苗组和安慰剂组之间是平衡的。由于B.1.351变异，两剂ChAdOx1 nCoV-19疫苗方案没有显示出对轻度至中度Covid-19的保护。（由比尔及梅林达·盖茨基金会等资助；ClinicalTrials.gov编号：NCT04444674；泛非临床试验注册编号：PACTR202006922165132）。
Assessment of the safety and efficacy of vaccines against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in different populations is essential, as is investigation of the efficacy of the vaccines against emerging SARS-CoV-2 variants of concern, including the B.1.351 (501Y.V2) variant first identified in South Africa. We conducted a multicenter, double-blind, randomized, controlled trial to assess the safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) in people not infected with the human immunodeficiency virus (HIV) in South Africa. Participants 18 to less than 65 years of age were assigned in a 1:1 ratio to receive two doses of vaccine containing 5×1010 viral particles or placebo (0.9% sodium chloride solution) 21 to 35 days apart. Serum samples obtained from 25 participants after the second dose were tested by pseudovirus and live-virus neutralization assays against the original D614G virus and the B.1.351 variant. The primary end points were safety and efficacy of the vaccine against laboratory-confirmed symptomatic coronavirus 2019 illness (Covid-19) more than 14 days after the second dose. Between June 24 and November 9, 2020, we enrolled 2026 HIV-negative adults (median age, 30 years); 1010 and 1011 participants received at least one dose of placebo or vaccine, respectively. Both the pseudovirus and the live-virus neutralization assays showed greater resistance to the B.1.351 variant in serum samples obtained from vaccine recipients than in samples from placebo recipients. In the primary end-point analysis, mild-to-moderate Covid-19 developed in 23 of 717 placebo recipients (3.2%) and in 19 of 750 vaccine recipients (2.5%), for an efficacy of 21.9% (95% confidence interval [CI], −49.9 to 59.8). Among the 42 participants with Covid-19, 39 cases (92.9%) were caused by the B.1.351 variant; vaccine efficacy against this variant, analyzed as a secondary end point, was 10.4% (95% CI, −76.8 to 54.8). The incidence of serious adverse events was balanced between the vaccine and placebo groups. A two-dose regimen of the ChAdOx1 nCoV-19 vaccine did not show protection against mild-to-moderate Covid-19 due to the B.1.351 variant. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov number, NCT04444674; Pan African Clinical Trials Registry number, PACTR202006922165132).