Efficacy of primary series AZD1222 (ChAdOx1 nCoV-19) vaccination against SARS-CoV-2 variants of concern: Final analysis of a randomized, placebo-controlled, phase 1b/2 study in South African adults (COV005)

被引：4

作者：

Koen, Anthonet L. ^{[1
]}

Izu, Alane ^{[1
]}

Baillie, Vicky ^{[1
]}

Kwatra, Gaurav ^{[1
,2
]}

Cutland, Clare L. ^{[3
]}

Fairlie, Lee ^{[4
]}

Padayachee, Sherman D. ^{[5
]}

Dheda, Keertan ^{[6
,7
]}

Barnabas, Shaun L. ^{[8
]}

Bhorat, Qasim Ebrahim ^{[9
]}

Briner, Carmen ^{[10
]}

Ahmed, Khatija ^{[5
,11
]}

Bhikha, Sutika

Bhiman, Jinal N. ^{[12
,13
]}

du Plessis, Jeanine ^{[1
]}

Esmail, Aliasgar ^{[14
,15
]}

Horne, Elizea ^{[4
]}

Hwa, Shi-Hsia ^{[16
,17
]}

Oommen-Jose, Aylin ^{[1
]}

Lambe, Teresa ^{[18
,19
]}

Laubscher, Matt ^{[1
]}

Malahleha, Mookho ^{[5
,20
]}

Benade, Gabriella ^{[4
]}

McKenzie, Shakeel ^{[1
]}

Oelofse, Suzette ^{[14
,15
]}

Patel, Faeezah ^{[4
]}

Pillay, Sureshnee ^{[21
,22
]}

Rhead, Sarah ^{[18
]}

Rodel, Hylton ^{[16
,17
]}

Taoushanis, Carol ^{[1
]}

Tegally, Houriiyah ^{[21
,22
]}

Thombrayil, Asha ^{[1
]}

Villafana, Tonya L. ^{[23
]}

Gilbert, Sarah ^{[24
,25
]}

Pollard, Andrew J. ^{[18
,25
]}

Madhi, Shabir A. ^{[1
,26
]}

机构：

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

[2] Christian Med Coll & Hosp, Dept Clin Microbiol, Vellore, India

[3] Univ Witwatersrand, Fac Hlth Sci, African Leadership Vaccinol Expertise ALIVE, Johannesburg, South Africa

[4] Univ Witwatersrand, Wits Reprod Hlth & HIV Inst, Fac Hlth Sci, Johannesburg, South Africa

[5] Setshaba Res Ctr, Tshwane, South Africa

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

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

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

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

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

[11] Univ Pretoria, Fac Hlth Sci, Dept Med Microbiol, Pretoria, South Africa

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

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

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

[15] Univ Cape Town Lung Inst, Cape Town, South Africa

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

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

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

[19] Univ Oxford, Oxford Inst, Chinese Acad Med Sci, Oxford, England

[20] Synergy Biomed Res Inst, East London, Eastern Cape, South Africa

[21] Univ KwaZulu Natal, Sch Lab Med & Med Sci, KwaZulu Natal Res Innovat & Sequencing Platform KR, Durban, South Africa

[22] Stellenbosch Univ, Ctr Epidem Response & Innovat CERI, Stellenbosch, South Africa

[23] AstraZeneca, BioPharmaceut R&D, Clin Dev Vaccines & Immune Therapies, Gaithersburg, MD USA

[24] Univ Oxford, Nuffield Dept Med, ORCRB, Oxford, England

[25] NIHR Oxford Biomed Res Ctr, Oxford, England

[26] Natl Inst Allergy & Infect Dis, Antibody Biol Unit, Lab Immunogenet, NIH, Rockville, MD 20852 USA

来源：

VACCINE | 2023年 / 41卷 / 23期

基金：

英国科研创新办公室; 英国医学研究理事会;

关键词：

SARS-CoV-2; variant; COVID-19; AZD1222; ChAdOx1; nCov-19; Vaccine efficacy;

D O I：

10.1016/j.vaccine.2023.04.058

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

COVID-19 vaccine efficacy (VE) has been observed to vary against antigenically distinct SARS-CoV-2 variants of concern (VoC). Here we report the final analysis of VE and safety from COV005: a phase 1b/2, multicenter, double-blind, randomized, placebo-controlled study of primary series AZD1222 (ChAdOx1 nCoV-19) vaccination in South African adults aged 18-65 years. South Africa's first, second, and third waves of SARS-CoV-2 infections were respectively driven by the ancestral SARS-CoV-2 virus (wild type, WT), and SARS-CoV-2 Beta and Delta VoCs. VE against asymptomatic and symptomatic infection was 90.6% for WT, 6.7% for Beta and 77.1% for Delta. No cases of severe COVID-19 were documented ahead of unblinding. Safety was consistent with the interim analysis, with no new safety concerns identified. Notably, South Africa's Delta wave occurred >= 9 months after primary series vaccination, suggesting that primary series AZD1222 vaccination offers a good durability of protection, potentially due to an anamnestic response. (C) 2023 Published by Elsevier Ltd.

引用

页码：3486 / 3492

页数：7

共 19 条

[1] Sensitive Recovery of Complete SARS-CoV-2 Genomes from Clinical Samples by Use of Swift Biosciences' SARS-CoV-2 Multiplex Amplicon Sequencing Panel [J].

Addetia, Amin ;

Lin, Michelle J. ;

Peddu, Vikas ;

Roychoudhury, Pavitra ;

Jerome, Keith R. ;

Greninger, Alexander L. .

JOURNAL OF CLINICAL MICROBIOLOGY, 2021, 59 (01)

[2] Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant [J].

Bernal, Jamie Lopez ;

Andrews, Nick ;

Gower, Charlotte ;

Gallagher, Eileen ;

Simmons, Ruth ;

Thelwall, Simon ;

Stowe, Julia ;

Tessier, Elise ;

Groves, Natalie ;

Dabrera, Gavin ;

Myers, Richard ;

Campbell, Colin N. J. ;

Amirthalingam, Gayatri ;

Edmunds, Matt ;

Zambon, Maria ;

Brown, Kevin E. ;

Hopkins, Susan ;

Chand, Meera ;

Ramsay, Mary .

NEW ENGLAND JOURNAL OF MEDICINE, 2021, 385 (07) :585-594

[3] Genome Detective Coronavirus Typing Tool for rapid identification and characterization of novel coronavirus genomes [J].

Cleemput, Sara ;

Dumon, Wim ;

Fonseca, Vagner ;

Karim, Wasim Abdool ;

Giovanetti, Marta ;

Alcantara, Luiz Carlos ;

Deforche, Koen ;

de Oliveira, Tulio .

BIOINFORMATICS, 2020, 36 (11) :3552-3555

[4] Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial [J].

Emary, Katherine R. W. ;

Golubchik, Tanya ;

Aley, Parvinder K. ;

Ariani, Cristina, V ;

Angus, Brian ;

Bibi, Sagida ;

Blane, Beth ;

Bonsall, David ;

Cicconi, Paola ;

Charlton, Sue ;

Clutterbuck, Elizabeth A. ;

Collins, Andrea M. ;

Cox, Tony ;

Darton, Thomas C. ;

Dold, Christina ;

Douglas, Alexander D. ;

Duncan, Christopher J. A. ;

Ewer, Katie J. ;

Flaxman, Amy L. ;

Faust, Saul N. ;

Ferreira, Daniela M. ;

Feng, Shuo ;

Finn, Adam ;

Folegatti, Pedro M. ;

Fuskova, Michelle ;

Galiza, Eva ;

Goodman, Anna L. ;

Green, Catherine M. ;

Green, Christopher A. ;

Greenland, Melanie ;

Hallis, Bassam ;

Heath, Paul T. ;

Hay, Jodie ;

Hill, Helen C. ;

Jenkin, Daniel ;

Kerridge, Simon ;

Lazarus, Rajeka ;

Libri, Vincenzo ;

Lillie, Patrick J. ;

Ludden, Catherine ;

Marchevsky, Natalie G. ;

Minassian, Angela M. ;

McGregor, Alastair C. ;

Mujadidi, Yama F. ;

Phillips, Daniel J. ;

Plested, Emma ;

Pollock, Katrina M. ;

Robinson, Hannah ;

Smith, Andrew ;

Song, Rinn .

LANCET, 2021, 397 (10282) :1351-1362

[5] Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine [J].

Falsey, Ann R. ;

Sobieszczyk, Magdalena E. ;

Hirsch, Ian ;

Sproule, Stephanie ;

Robb, Merlin L. ;

Corey, Lawrence ;

Neuzil, Kathleen M. ;

Hahn, William ;

Hunt, Julie ;

Mulligan, Mark J. ;

McEvoy, Charlene ;

DeJesus, Edwin ;

Hassman, Michael ;

Little, Susan J. ;

Pahud, Barbara A. ;

Durbin, Anna ;

Pickrell, Paul ;

Daar, Eric S. ;

Bush, Larry ;

Solis, Joel ;

Carr, Quito Osuna ;

Oyedele, Temitope ;

Buchbinder, Susan ;

Cowden, Jessica ;

Vargas, Sergio L. ;

Benavides, Alfredo Guerreros ;

Call, Robert ;

Keefer, Michael C. ;

Kirkpatrick, Beth D. ;

Pullman, John ;

Tong, Tina ;

Isaacs, Margaret Brewinski ;

Benkeser, David ;

Janes, Holly E. ;

Nason, Martha C. ;

Green, Justin A. ;

Kelly, Elizabeth J. ;

Maaske, Jill ;

Mueller, Nancy ;

Shoemaker, Kathryn ;

Takas, Therese ;

Marshall, Richard P. ;

Pangalos, Menelas N. ;

Villafana, Tonya ;

Gonzalez-Lopez, Antonio .

NEW ENGLAND JOURNAL OF MEDICINE, 2021, 385 (25) :2348-2360

[6]

Giandhari J, NEBNEXT LIB CONSTRUC

[7]

Kirsebom F, 2022, MEDXRIV

[8] US CDC Real-Time Reverse Transcription PCR Panel for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 [J].

Lu, Xiaoyan ;

Wang, Lijuan ;

Sakthivel, Senthilkumar K. ;

Whitaker, Brett ;

Murray, Janna ;

Kamili, Shifaq ;

Lynch, Brian ;

Malapati, Lakshmi ;

Burke, Stephen A. ;

Harcourt, Jennifer ;

Tamin, Azaibi ;

Thornburg, Natalie J. ;

Villanueva, Julie M. ;

Lindstrom, Stephen .

EMERGING INFECTIOUS DISEASES, 2020, 26 (08) :1654-1665

[9] Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant [J].

Madhi, S. A. ;

Baillie, V ;

Cutland, C. L. ;

Voysey, M. ;

Koen, A. L. ;

Fairlie, L. ;

Padayachee, S. D. ;

Dheda, K. ;

Barnabas, S. L. ;

Bhorat, Q. E. ;

Briner, C. ;

Kwatra, G. ;

Ahmed, K. ;

Aley, P. ;

Bhikha, S. ;

Bhiman, J. N. ;

Bhorat, A' E. ;

du Plessis, J. ;

Esmail, A. ;

Groenewald, M. ;

Horne, E. ;

Hwa, S-H ;

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, C. K. ;

Durham, N. M. ;

Kelly, E. J. ;

Villafana, T. L. ;

Gilbert, S. ;

Pollard, A. J. ;

de Oliveira, T. ;

Moore, P. L. ;

Sigal, A. .

NEW ENGLAND JOURNAL OF MEDICINE, 2021, 384 (20) :1885-1898

[10] Population Immunity and Covid-19 Severity with Omicron Variant in South Africa [J].

Madhi, Shabir A. ;

Kwatra, Gaurav ;

Myers, Jonathan E. ;

Jassat, Waasila ;

Dhar, Nisha ;

Mukendi, Christian K. ;

Nana, Amit J. ;

Blumberg, Lucille ;

Welch, Richard ;

Ngorima-Mabhena, Nicoletta ;

Mutevedzi, Portia C. .

NEW ENGLAND JOURNAL OF MEDICINE, 2022, 386 (14) :1314-1326

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