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

作者：Shabir A. Madhi, Anthonet Koen, Alane Izu, Lee Fairlie, Clare Cutland, Vicky L. Baillie, Sherman D. Padayachee, Keertan Dheda, Shaun Barnabas, Qasim Bhorat, Carmen Briner, Parvinder K. Aley, Sutika Bhikha, Tandile Hermanus, Elizea Horne, Aylin Jose, Prudence Kgagudi, Teresa Lambe, Masebole Masenya, Mduduzi Masilela, Nonhlanhla N. Mkhize, Andrew Moultrie, Christian K. Mukendi, Thandeka Moyo-Gwete, Amit J Nana, Ayanda Nzimande, Faeezah Patel, Sarah Rhead, Carol Taoushanis, Asha Thombrayil, Samuel van Eck, Merryn Voysey, Tonya Villafana, Johan Vekemans, Sarah C. Gilbert, Andrew J. Pollard, Penny L. Moore, Gaurav Kwatra · 发表于：The Lancet HIV · 年份：2021 · DOI：10.1016/s2352-3018(21)00157-0 · 被引用次数：162 · 研究领域：SARS-CoV-2 and COVID-19 Research、COVID-19 Clinical Research Studies、Long-Term Effects of COVID-19

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) rece...