Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant

被引：371

作者：

Shinde, V. ^{[1
]}

Bhikha, S. ^{[2
]}

Hoosain, Z. ^{[5
]}

Archary, M. ^{[6
]}

Bhorat, Q. ^{[4
]}

Fairlie, L. ^{[1
,3
]}

Lalloo, U. ^{[7
]}

Masilela, M. S. L.

Moodley, D. ^{[8
]}

Hanley, S. ^{[9
]}

Fouche, L. ^{[11
]}

Louw, C. ^{[12
]}

Tameris, M. ^{[14
]}

Singh, N. ^{[14
,17
,18
]}

Goga, A. ^{[17
,18
]}

Dheda, K. ^{[15
,16
]}

Grobbelaar, C. ^{[13
]}

Kruger, G. ^{[19
]}

Carrim-Ganey, N. ^{[20
]}

Baillie, V. ^{[2
]}

de Oliveira, T. ^{[10
]}

Koen, A. Lombard ^{[2
]}

Lombaard, J. J. ^{[5
]}

Mngqibisa, R. ^{[6
]}

Bhorat, A. E. ^{[4
]}

Benade, G. ^{[3
]}

Lalloo, N. ^{[7
]}

Pitsi, A.

Vollgraaff, P. -L. ^{[11
]}

Luabeya, A. ^{[14
]}

Esmail, A. ^{[15
,16
]}

Petrick, F. G. ^{[19
]}

Oommen-Jose, A. ^{[2
]}

Foulkes, S. ^{[5
]}

Ahmed, K.

Thombrayil, A. ^{[2
]}

Fries, L.

Cloney-Clark, S. ^{[1
]}

Zhu, M. ^{[1
]}

Bennett, C.

Albert, G. ^{[1
]}

Faust, E. ^{[1
]}

Plested, J. S. ^{[1
]}

Robertson, A. ^{[1
]}

Neal, S. ^{[1
]}

Cho, I. ^{[1
]}

Glenn, G. M. ^{[1
]}

Dubovsky, F. ^{[1
]}

Madhi, S. A. ^{[2
]}

机构：

[1] Novavax, 21 Firstfield Rd, Gaithersburg, MD 20878 USA

[2] Univ Witwatersrand, Fac Hlth Sci, South African Med Res Council, Vaccines & Infect Dis Analyt Res Unit, Johannesburg, South Africa

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

[4] Soweto Clin Trials Ctr, Johannesburg, South Africa

[5] Josha Res Ctr, Bloemfontein, South Africa

[6] Univ KwaZulu Natal, Nelson R Mandela Sch Med, Paediat Infect Dis Unit, Durban, South Africa

[7] Univ KwaZulu Natal, Nelson R Mandela Sch Med, Resp & Crit Care Unit, Durban, South Africa

[8] Univ KwaZulu Natal, Nelson R Mandela Sch Med, Dept Obstet & Gynaecol, Durban, South Africa

[9] Univ KwaZulu Natal, Nelson R Mandela Sch Med, Ctr AIDS Programme Res South Africa, Durban, South Africa

[10] Univ KwaZulu Natal, Nelson R Mandela Sch Med, Kwazulu Natal Res Innovat & Sequencing Platform, Durban, South Africa

[11] Limpopo Clin Res Initiat, Rustenburg, South Africa

[12] Univ Pretoria, Sch Hlth, Dept Family Med, Madibeng Ctr Res, Pretoria, South Africa

[13] Aurum Inst, Pretoria, South Africa

[14] Univ Cape Town, South African TB Vaccine Initiat, Cape Town, South Africa

[15] Univ Cape Town, Ctr Lung Infect & Immun, Dept Med, Div Pulmonol, Cape Town, South Africa

[16] Univ Cape Town, UCT Lung Inst, Cape Town, South Africa

[17] South African Med Res Council, Hlth Syst Res Unit, Cape Town, South Africa

[18] South African Med Res Council, HIV Prevent Res Unit, Cape Town, South Africa

[19] Mzansi Eth Res Ctr, Middelburg, South Africa

[20] Peermed Clin Trial Ctr, Kempton Pk, South Africa

来源：

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

关键词：

RECEPTOR-BINDING DOMAIN;

D O I：

10.1056/NEJMoa2103055

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants threatens progress toward control of the coronavirus disease 2019 (Covid-19) pandemic. In a phase 1-2 trial involving healthy adults, the NVXCoV2373 nanoparticle vaccine had an acceptable safety profile and was associated with strong neutralizing-antibody and antigen-specific polyfunctional CD4+T-cell responses. Evaluation of vaccine efficacy was needed in a setting of ongoing SARSCoV-2 transmission. METHODS In this phase 2a-b trial in South Africa, we randomly assigned human immunodeficiency virus (HIV)-negative adults between the ages of 18 and 84 years or medically stable HIV-positive participants between the ages of 18 and 64 years in a 1:1 ratio to receive two doses of either the NVX-CoV2373 vaccine (5 mu g of recombinant spike protein with 50 mu g of Matrix-M1 adjuvant) or placebo. The primary end points were safety and vaccine efficacy against laboratory-confirmed symptomatic Covid-19 at 7 days or more after the second dose among participants without previous SARS-CoV-2 infection. RESULTS Of 6324 participants who underwent screening, 4387 received at least one injection of vaccine or placebo. Approximately 30% of the participants were seropositive for SARS-CoV-2 at baseline. Among 2684 baseline seronegative participants (94% HIV-negative and 6% HIV-positive), predominantly mild-to-moderate Covid-19 developed in 15 participants in the vaccine group and in 29 in the placebo group (vaccine efficacy, 49.4%; 95% confidence interval [CI], 6.1 to 72.8). Vaccine efficacy among HIV-negative participants was 60.1% (95% CI, 19.9 to 80.1). Of 41 sequenced isolates, 38 (92.7%) were the B.1.351 variant. Post hoc vaccine efficacy against B.1.351 was 51.0% (95% CI, -0.6 to 76.2) among the HIV-negative participants. Preliminary local and systemic reactogenicity events were more common in the vaccine group; serious adverse events were rare in both groups. CONCLUSIONS The NVX-CoV2373 vaccine was efficacious in preventing Covid-19, with higher vaccine efficacy observed among HIV-negative participants. Most infections were caused by the B.1.351 variant.

引用

页码：1899 / 1909

页数：11

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