Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant

被引：859

作者：

Madhi, S. A. ^{[1
,6
]}

Baillie, V ^{[1
,6
]}

Cutland, C. L. ^{[2
]}

Voysey, M. ^{[16
]}

Koen, A. L. ^{[1
,6
]}

Fairlie, L. ^{[3
]}

Padayachee, S. D. ^{[8
]}

Dheda, K. ^{[9
,10
,18
,19
]}

Barnabas, S. L. ^{[11
]}

Bhorat, Q. E. ^{[12
]}

Briner, C. ^{[5
]}

Kwatra, G. ^{[1
,6
]}

Ahmed, K. ^{[8
]}

Aley, P. ^{[16
]}

Bhikha, S. ^{[1
,6
]}

Bhiman, J. N. ^{[4
,7
]}

Bhorat, A' E. ^{[12
]}

du Plessis, J. ^{[1
]}

Esmail, A. ^{[9
,10
,18
]}

Groenewald, M. ^{[11
]}

Horne, E. ^{[3
]}

Hwa, S-H ^{[13
,14
,21
]}

Jose, A. ^{[1
]}

Lambe, T. ^{[17
]}

Laubscher, M. ^{[1
]}

Malahleha, M. ^{[8
]}

Masenya, M. ^{[3
]}

Masilela, M. ^{[8
]}

McKenzie, S. ^{[1
]}

Molapo, K. ^{[8
]}

Moultrie, A. ^{[1
]}

Oelofse, S. ^{[9
,10
]}

Patel, F. ^{[3
]}

Pillay, S. ^{[15
]}

Rhead, S. ^{[16
]}

Rodel, H. ^{[13
,14
,21
]}

Rossouw, L. ^{[11
]}

Taoushanis, C. ^{[1
]}

Tegally, H. ^{[15
]}

Thombrayil, A. ^{[1
]}

van Eck, S. ^{[3
]}

Wibmer, C. K. ^{[4
,7
]}

Durham, N. M. ^{[20
]}

Kelly, E. J. ^{[20
]}

Villafana, T. L. ^{[20
]}

Gilbert, S. ^{[17
]}

Pollard, A. J. ^{[16
]}

de Oliveira, T. ^{[15
]}

Moore, P. L. ^{[4
,7
]}

Sigal, A. ^{[13
,14
,15
]}

机构：

[1] Univ Witwatersrand, South African Med Res Council, Vaccines & Infect Dis Analyt Res Unit, Johannesburg, South Africa

[2] Univ Witwatersrand, African Leadership Vaccinol Expertise, Johannesburg, South Africa

[3] Univ Witwatersrand, Wits Reprod Hlth & HIV Inst, Johannesburg, South Africa

[4] Univ Witwatersrand, Sch Pathol, Antibody Immun Res Unit, Johannesburg, South Africa

[5] Univ Witwatersrand, Fac Hlth Sci, Perinatal HIV Res Unit, Johannesburg, South Africa

[6] Univ Witwatersrand, Dept Sci & Innovat, Natl Res Fdn South African Res Chair Initiat, Vaccine Preventable Dis Unit, Johannesburg, South Africa

[7] Natl Hlth Lab Serv NHLS, Natl Inst Communicable Dis NICD, Johannesburg, South Africa

[8] Setshaba Res Ctr, Tshwane, South Africa

[9] Groote Schuur Hosp, Div Pulmonol, Cape Town, South Africa

[10] Univ Cape Town, Cape Town, South Africa

[11] Univ Stellenbosch, Family Ctr Res Ubuntu, Dept Paediat, Cape Town, South Africa

[12] Soweto Clin Trials Ctr, Soweto, South Africa

[13] Africa Hlth Res Inst, Durban, South Africa

[14] Univ KwaZulu Natal, Africa Hlth Res Inst, Durban, South Africa

[15] Univ KwaZulu Natal, KwaZulu Natal Res & Innovat Sequencing Platform K, Durban, South Africa

[16] Univ Oxford, Oxford Vaccine Grp, Dept Paediat, Oxford, England

[17] Univ Oxford, Jenner Inst, Nuffield Dept Med, Oxford, England

[18] London Sch Hyg & Trop Med, Fac Infect & Trop Dis, Dept Immunol & Infect, London, England

[19] UCL, Div Infect & Immun, London, England

[20] AstraZeneca Biopharmaceut, Cambridge, England

[21] Max Planck Inst Infect Biol, Berlin, Germany

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2021年 / 384卷 / 20期

基金：

新加坡国家研究基金会; 英国医学研究理事会; 美国国家卫生研究院;

关键词：

D O I：

10.1056/NEJMoa2102214

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND 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. METHODS 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 5x10(10) 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. RESULTS 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 (95.1% of 41 with sequencing data) 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. CONCLUSIONS 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.

引用

页码：1885 / 1898

页数：14

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