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)
<p>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 AZD12...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
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Elsevier
2023
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| _version_ | 1826312823236460544 |
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| author | Koen, AL Izu, A Baillie, V Kwatra, G Cutland, CL Fairlie, L Padayachee, SD Dheda, K Barnabas, SL Bhorat, QE Briner, C Ahmed, K Bhikha, S Bhiman, JN du Plessis, J Esmail, A Horne, E Hwa, S-H Oommen-Jose, A Lambe, T Laubscher, M Malahleha, M Benade, G McKenzie, S Oelofse, S Patel, F Pillay, S Rhead, S Rodel, H Taoushanis, C Tegally, H Thombrayil, A Villafana, TL Gilbert, S Pollard, AJ Madhi, SA |
| author_facet | Koen, AL Izu, A Baillie, V Kwatra, G Cutland, CL Fairlie, L Padayachee, SD Dheda, K Barnabas, SL Bhorat, QE Briner, C Ahmed, K Bhikha, S Bhiman, JN du Plessis, J Esmail, A Horne, E Hwa, S-H Oommen-Jose, A Lambe, T Laubscher, M Malahleha, M Benade, G McKenzie, S Oelofse, S Patel, F Pillay, S Rhead, S Rodel, H Taoushanis, C Tegally, H Thombrayil, A Villafana, TL Gilbert, S Pollard, AJ Madhi, SA |
| author_sort | Koen, AL |
| collection | OXFORD |
| description | <p>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.</p>
<p>Clinical trial identifier: CT.gov NCT04444674.</p> |
| first_indexed | 2024-03-07T07:44:48Z |
| format | Journal article |
| id | oxford-uuid:00ed3926-93e2-4519-b4c5-35d280461144 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-09-25T04:01:07Z |
| publishDate | 2023 |
| publisher | Elsevier |
| record_format | dspace |
| spelling | oxford-uuid:00ed3926-93e2-4519-b4c5-35d2804611442024-04-29T08:50:22ZEfficacy 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)Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:00ed3926-93e2-4519-b4c5-35d280461144EnglishSymplectic ElementsElsevier2023Koen, ALIzu, ABaillie, VKwatra, GCutland, CLFairlie, LPadayachee, SDDheda, KBarnabas, SLBhorat, QEBriner, CAhmed, KBhikha, SBhiman, JNdu Plessis, JEsmail, AHorne, EHwa, S-HOommen-Jose, ALambe, TLaubscher, MMalahleha, MBenade, GMcKenzie, SOelofse, SPatel, FPillay, SRhead, SRodel, HTaoushanis, CTegally, HThombrayil, AVillafana, TLGilbert, SPollard, AJMadhi, SA<p>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.</p> <p>Clinical trial identifier: CT.gov NCT04444674.</p> |
| spellingShingle | Koen, AL Izu, A Baillie, V Kwatra, G Cutland, CL Fairlie, L Padayachee, SD Dheda, K Barnabas, SL Bhorat, QE Briner, C Ahmed, K Bhikha, S Bhiman, JN du Plessis, J Esmail, A Horne, E Hwa, S-H Oommen-Jose, A Lambe, T Laubscher, M Malahleha, M Benade, G McKenzie, S Oelofse, S Patel, F Pillay, S Rhead, S Rodel, H Taoushanis, C Tegally, H Thombrayil, A Villafana, TL Gilbert, S Pollard, AJ Madhi, SA 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) |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
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