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
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
收藏
页码:3486 / 3492
页数:7
相关论文
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