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Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in people living with and without HIV in South Africa: an interim analysis of a randomised, double-blind, placebo-controlled, phase 1B/2A trial

BACKGROUND: People living with HIV are at an increased risk of fatal outcome when admitted to hospital for severe COVID-19 compared with HIV-negative individuals. We aimed to assess safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in people with HIV and HIV-negative individuals in...

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Autores principales: Madhi, Shabir A, Koen, Anthonet L, Izu, Alane, Fairlie, Lee, Cutland, Clare L, Baillie, Vicky, Padayachee, Sherman D, Dheda, Keertan, Barnabas, Shaun L, Bhorat, Qasim Ebrahim, Briner, Carmen, Aley, Parvinder K, Bhikha, Sutika, Hermanus, Tandile, Horne, Elizea, Jose, Aylin, Kgagudi, Prudence, Lambe, Teresa, Masenya, Masebole, Masilela, Mduduzi, Mkhize, Nonhlanhla, Moultrie, Andrew, Mukendi, Christian K, Moyo-Gwete, Thandeka, Nana, Amit J, Nzimande, Ayanda, Patel, Faeezah, Rhead, Sarah, Taoushanis, Carol, Thombrayil, Asha, van Eck, Samuel, Voysey, Merryn, Villafana, Tonya L, Vekemans, Johan, Gilbert, Sarah C, Pollard, Andrew J, Moore, Penny L, Kwatra, Gaurav
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier B.V 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8372504/
https://www.ncbi.nlm.nih.gov/pubmed/34416193
http://dx.doi.org/10.1016/S2352-3018(21)00157-0
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author Madhi, Shabir A
Koen, Anthonet L
Izu, Alane
Fairlie, Lee
Cutland, Clare L
Baillie, Vicky
Padayachee, Sherman D
Dheda, Keertan
Barnabas, Shaun L
Bhorat, Qasim Ebrahim
Briner, Carmen
Aley, Parvinder K
Bhikha, Sutika
Hermanus, Tandile
Horne, Elizea
Jose, Aylin
Kgagudi, Prudence
Lambe, Teresa
Masenya, Masebole
Masilela, Mduduzi
Mkhize, Nonhlanhla
Moultrie, Andrew
Mukendi, Christian K
Moyo-Gwete, Thandeka
Nana, Amit J
Nzimande, Ayanda
Patel, Faeezah
Rhead, Sarah
Taoushanis, Carol
Thombrayil, Asha
van Eck, Samuel
Voysey, Merryn
Villafana, Tonya L
Vekemans, Johan
Gilbert, Sarah C
Pollard, Andrew J
Moore, Penny L
Kwatra, Gaurav
author_facet Madhi, Shabir A
Koen, Anthonet L
Izu, Alane
Fairlie, Lee
Cutland, Clare L
Baillie, Vicky
Padayachee, Sherman D
Dheda, Keertan
Barnabas, Shaun L
Bhorat, Qasim Ebrahim
Briner, Carmen
Aley, Parvinder K
Bhikha, Sutika
Hermanus, Tandile
Horne, Elizea
Jose, Aylin
Kgagudi, Prudence
Lambe, Teresa
Masenya, Masebole
Masilela, Mduduzi
Mkhize, Nonhlanhla
Moultrie, Andrew
Mukendi, Christian K
Moyo-Gwete, Thandeka
Nana, Amit J
Nzimande, Ayanda
Patel, Faeezah
Rhead, Sarah
Taoushanis, Carol
Thombrayil, Asha
van Eck, Samuel
Voysey, Merryn
Villafana, Tonya L
Vekemans, Johan
Gilbert, Sarah C
Pollard, Andrew J
Moore, Penny L
Kwatra, Gaurav
author_sort Madhi, Shabir A
collection PubMed
description BACKGROUND: People living with HIV are at an increased risk of fatal outcome when admitted to hospital for severe COVID-19 compared with HIV-negative individuals. We aimed to assess safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in people with HIV and HIV-negative individuals in South Africa. METHODS: In this ongoing, double-blind, placebo-controlled, phase 1B/2A trial (COV005), people with HIV and HIV-negative participants aged 18–65 years were enrolled at seven South African locations and were randomly allocated (1:1) with full allocation concealment to receive a prime-boost regimen of ChAdOx1 nCoV-19, with two doses given 28 days apart. Eligibility criteria for people with HIV included being on antiretroviral therapy for at least 3 months, with a plasma HIV viral load of less than 1000 copies per mL. In this interim analysis, safety and reactogenicity was assessed in all individuals who received at least one dose of ChAdOx1 nCov 19 between enrolment and Jan 15, 2021. Primary immunogenicity analyses included participants who received two doses of trial intervention and were SARS-CoV-2 seronegative at baseline. This trial is registered with ClinicalTrials.gov, NCT04444674, and the Pan African Clinicals Trials Registry, PACTR202006922165132. FINDINGS: Between June 24 and Nov 12, 2020, 104 people with HIV and 70 HIV-negative individuals were enrolled. 102 people with HIV (52 vaccine; 50 placebo) and 56 HIV-negative participants (28 vaccine; 28 placebo) received the priming dose, 100 people with HIV (51 vaccine; 49 placebo) and 46 HIV-negative participants (24 vaccine; 22 placebo) received two doses (priming and booster). In participants seronegative for SARS-CoV-2 at baseline, there were 164 adverse events in those with HIV (86 vaccine; 78 placebo) and 237 in HIV-negative participants (95 vaccine; 142 placebo). Of seven serious adverse events, one severe fever in a HIV-negative participant was definitely related to trial intervention and one severely elevated alanine aminotranferase in a participant with HIV was unlikely related; five others were deemed unrelated. One person with HIV died (unlikely related). People with HIV and HIV-negative participants showed vaccine-induced serum IgG responses against wild-type Wuhan-1 Asp614Gly (also known as D614G). For participants seronegative for SARS-CoV-2 antigens at baseline, full-length spike geometric mean concentration (GMC) at day 28 was 163·7 binding antibody units (BAU)/mL (95% CI 89·9–298·1) for people with HIV (n=36) and 112·3 BAU/mL (61·7–204·4) for HIV-negative participants (n=23), with a rising day 42 GMC booster response in both groups. Baseline SARS-CoV-2 seropositive people with HIV demonstrated higher antibody responses after each vaccine dose than did people with HIV who were seronegative at baseline. High-level binding antibody cross-reactivity for the full-length spike and receptor-binding domain of the beta variant (B.1.351) was seen regardless of HIV status. In people with HIV who developed high titre responses, predominantly those who were receptor-binding domain seropositive at enrolment, neutralising activity against beta was retained. INTERPRETATION: ChAdOx1 nCoV-19 was well tolerated, showing favourable safety and immunogenicity in people with HIV, including heightened immunogenicity in SARS-CoV-2 baseline-seropositive participants. People with HIV showed cross-reactive binding antibodies to the beta variant and Asp614Gly wild-type, and high responders retained neutralisation against beta. FUNDING: The Bill & Melinda Gates Foundation, South African Medical Research Council, UK Research and Innovation, UK National Institute for Health Research, and the South African Medical Research Council.
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spelling pubmed-83725042021-08-18 Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in people living with and without HIV in South Africa: an interim analysis of a randomised, double-blind, placebo-controlled, phase 1B/2A trial Madhi, Shabir A Koen, Anthonet L Izu, Alane Fairlie, Lee Cutland, Clare L Baillie, Vicky Padayachee, Sherman D Dheda, Keertan Barnabas, Shaun L Bhorat, Qasim Ebrahim Briner, Carmen Aley, Parvinder K Bhikha, Sutika Hermanus, Tandile Horne, Elizea Jose, Aylin Kgagudi, Prudence Lambe, Teresa Masenya, Masebole Masilela, Mduduzi Mkhize, Nonhlanhla Moultrie, Andrew Mukendi, Christian K Moyo-Gwete, Thandeka Nana, Amit J Nzimande, Ayanda Patel, Faeezah Rhead, Sarah Taoushanis, Carol Thombrayil, Asha van Eck, Samuel Voysey, Merryn Villafana, Tonya L Vekemans, Johan Gilbert, Sarah C Pollard, Andrew J Moore, Penny L Kwatra, Gaurav Lancet HIV Articles BACKGROUND: People living with HIV are at an increased risk of fatal outcome when admitted to hospital for severe COVID-19 compared with HIV-negative individuals. We aimed to assess safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in people with HIV and HIV-negative individuals in South Africa. METHODS: In this ongoing, double-blind, placebo-controlled, phase 1B/2A trial (COV005), people with HIV and HIV-negative participants aged 18–65 years were enrolled at seven South African locations and were randomly allocated (1:1) with full allocation concealment to receive a prime-boost regimen of ChAdOx1 nCoV-19, with two doses given 28 days apart. Eligibility criteria for people with HIV included being on antiretroviral therapy for at least 3 months, with a plasma HIV viral load of less than 1000 copies per mL. In this interim analysis, safety and reactogenicity was assessed in all individuals who received at least one dose of ChAdOx1 nCov 19 between enrolment and Jan 15, 2021. Primary immunogenicity analyses included participants who received two doses of trial intervention and were SARS-CoV-2 seronegative at baseline. This trial is registered with ClinicalTrials.gov, NCT04444674, and the Pan African Clinicals Trials Registry, PACTR202006922165132. FINDINGS: Between June 24 and Nov 12, 2020, 104 people with HIV and 70 HIV-negative individuals were enrolled. 102 people with HIV (52 vaccine; 50 placebo) and 56 HIV-negative participants (28 vaccine; 28 placebo) received the priming dose, 100 people with HIV (51 vaccine; 49 placebo) and 46 HIV-negative participants (24 vaccine; 22 placebo) received two doses (priming and booster). In participants seronegative for SARS-CoV-2 at baseline, there were 164 adverse events in those with HIV (86 vaccine; 78 placebo) and 237 in HIV-negative participants (95 vaccine; 142 placebo). Of seven serious adverse events, one severe fever in a HIV-negative participant was definitely related to trial intervention and one severely elevated alanine aminotranferase in a participant with HIV was unlikely related; five others were deemed unrelated. One person with HIV died (unlikely related). People with HIV and HIV-negative participants showed vaccine-induced serum IgG responses against wild-type Wuhan-1 Asp614Gly (also known as D614G). For participants seronegative for SARS-CoV-2 antigens at baseline, full-length spike geometric mean concentration (GMC) at day 28 was 163·7 binding antibody units (BAU)/mL (95% CI 89·9–298·1) for people with HIV (n=36) and 112·3 BAU/mL (61·7–204·4) for HIV-negative participants (n=23), with a rising day 42 GMC booster response in both groups. Baseline SARS-CoV-2 seropositive people with HIV demonstrated higher antibody responses after each vaccine dose than did people with HIV who were seronegative at baseline. High-level binding antibody cross-reactivity for the full-length spike and receptor-binding domain of the beta variant (B.1.351) was seen regardless of HIV status. In people with HIV who developed high titre responses, predominantly those who were receptor-binding domain seropositive at enrolment, neutralising activity against beta was retained. INTERPRETATION: ChAdOx1 nCoV-19 was well tolerated, showing favourable safety and immunogenicity in people with HIV, including heightened immunogenicity in SARS-CoV-2 baseline-seropositive participants. People with HIV showed cross-reactive binding antibodies to the beta variant and Asp614Gly wild-type, and high responders retained neutralisation against beta. FUNDING: The Bill & Melinda Gates Foundation, South African Medical Research Council, UK Research and Innovation, UK National Institute for Health Research, and the South African Medical Research Council. Elsevier B.V 2021-08-17 /pmc/articles/PMC8372504/ /pubmed/34416193 http://dx.doi.org/10.1016/S2352-3018(21)00157-0 Text en © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Articles
Madhi, Shabir A
Koen, Anthonet L
Izu, Alane
Fairlie, Lee
Cutland, Clare L
Baillie, Vicky
Padayachee, Sherman D
Dheda, Keertan
Barnabas, Shaun L
Bhorat, Qasim Ebrahim
Briner, Carmen
Aley, Parvinder K
Bhikha, Sutika
Hermanus, Tandile
Horne, Elizea
Jose, Aylin
Kgagudi, Prudence
Lambe, Teresa
Masenya, Masebole
Masilela, Mduduzi
Mkhize, Nonhlanhla
Moultrie, Andrew
Mukendi, Christian K
Moyo-Gwete, Thandeka
Nana, Amit J
Nzimande, Ayanda
Patel, Faeezah
Rhead, Sarah
Taoushanis, Carol
Thombrayil, Asha
van Eck, Samuel
Voysey, Merryn
Villafana, Tonya L
Vekemans, Johan
Gilbert, Sarah C
Pollard, Andrew J
Moore, Penny L
Kwatra, Gaurav
Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in people living with and without HIV in South Africa: an interim analysis of a randomised, double-blind, placebo-controlled, phase 1B/2A trial
title Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in people living with and without HIV in South Africa: an interim analysis of a randomised, double-blind, placebo-controlled, phase 1B/2A trial
title_full Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in people living with and without HIV in South Africa: an interim analysis of a randomised, double-blind, placebo-controlled, phase 1B/2A trial
title_fullStr Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in people living with and without HIV in South Africa: an interim analysis of a randomised, double-blind, placebo-controlled, phase 1B/2A trial
title_full_unstemmed Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in people living with and without HIV in South Africa: an interim analysis of a randomised, double-blind, placebo-controlled, phase 1B/2A trial
title_short Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in people living with and without HIV in South Africa: an interim analysis of a randomised, double-blind, placebo-controlled, phase 1B/2A trial
title_sort safety and immunogenicity of the chadox1 ncov-19 (azd1222) vaccine against sars-cov-2 in people living with and without hiv in south africa: an interim analysis of a randomised, double-blind, placebo-controlled, phase 1b/2a trial
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8372504/
https://www.ncbi.nlm.nih.gov/pubmed/34416193
http://dx.doi.org/10.1016/S2352-3018(21)00157-0
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