Safety and immunogenicity of ChAdOx1 nCoV-19 (AZD1222) vaccine in adults in Kenya: a phase 1/2 single-blind, randomised controlled trial.

Autor:	Hamaluba M; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Sang S; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Orindi B; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Njau I; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Karanja H; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Kamau N; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Gitonga JN; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Mugo D; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Wright D; Oxford Vaccine Group, University of Oxford, Oxford, England, UK., Nyagwange J; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Kutima B; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Omuoyo D; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Mwatasa M; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Ngetsa C; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Agoti C; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Cheruiyot S; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Nyaguara A; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Munene M; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Mturi N; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Oloo E; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Ochola-Oyier L; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Mumba N; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Mauncho C; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Namayi R; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Davies A; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.; Centre for Tropical Medicine & Global Health, University of Oxford, Oxford, England, UK., Tsofa B; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Nduati EW; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Aliyan N; Ministry of Health, Nairobi, Kenya., Kasera K; Ministry of Health, Nairobi, Kenya., Etyang A; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya., Boyd A; The Jenner Institute, University of Oxford, Oxford, England, UK., Hill A; The Jenner Institute, University of Oxford, Oxford, England, UK., Gilbert S; Pandemic Sciences Institute, University of Oxford, Oxford, England, UK., Douglas A; The Jenner Institute, University of Oxford, Oxford, England, UK., Pollard A; Oxford Vaccine Group, University of Oxford, Oxford, England, UK., Bejon P; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.; Centre for Tropical Medicine & Global Health, University of Oxford, Oxford, England, UK., Lambe T; Oxford Vaccine Group, University of Oxford, Oxford, England, UK.; Pandemic Sciences Institute, University of Oxford, Oxford, England, UK., Warimwe G; KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.; Centre for Tropical Medicine & Global Health, University of Oxford, Oxford, England, UK.
Jazyk:	angličtina
Zdroj:	Wellcome open research [Wellcome Open Res] 2023 Nov 27; Vol. 8, pp. 182. Date of Electronic Publication: 2023 Nov 27 (Print Publication: 2023).
DOI:	10.12688/wellcomeopenres.19150.2
Abstrakt:	Background: There are limited data on the immunogenicity of coronavirus disease 2019 (COVID-19) vaccines in African populations. Here we report the immunogenicity and safety of the ChAdOx1 nCoV-19 (AZD1222) vaccine from a phase 1/2 single-blind, randomised, controlled trial among adults in Kenya conducted as part of the early studies assessing vaccine performance in different geographical settings to inform Emergency Use Authorisation. Methods: We recruited and randomly assigned (1:1) 400 healthy adults aged ≥18 years in Kenya to receive ChAdOx1 nCoV-19 or control rabies vaccine, each as a two-dose schedule with a 3-month interval. The co-primary outcomes were safety, and immunogenicity assessed using total IgG enzyme-linked immunosorbent assay (ELISA) against SARS-CoV-2 spike protein 28 days after the second vaccination. Results: Between 28 th October 2020 and 19 th August 2021, 400 participants were enrolled and assigned to receive ChAdOx1 nCoV-19 (n=200) or rabies vaccine (n=200). Local and systemic adverse events were self-limiting and mild or moderate in nature. Three serious adverse events were reported but these were deemed unrelated to vaccination. The geometric mean anti-spike IgG titres 28 days after second dose vaccination were higher in the ChAdOx1 group (2773 ELISA units [EU], 95% CI 2447, 3142) than in the rabies vaccine group (61 EU, 95% CI 45, 81) and persisted over the 12 months follow-up. We did not identify any symptomatic infections or hospital admissions with respiratory illness and so vaccine efficacy against clinically apparent infection could not be measured. Vaccine efficacy against asymptomatic SARS-CoV-2 infection was 38.4% (95% CI -26.8%, 70.1%; p=0.188). Conclusions: The safety, immunogenicity and efficacy against asymptomatic infection of ChAdOx1 nCoV-19 among Kenyan adults was similar to that observed elsewhere in the world, but efficacy against symptomatic infection or severe disease could not be measured in this cohort. Pan-African Clinical Trials Registration: PACTR202005681895696 (11/05/2020). Competing Interests: Competing interests: SCG and AVSH are cofounders of Vaccitech, a collaborator in the early development of ChAdOx1 nCoV-19 and are named inventors on a patent covering use of ChAdOx1-vectored vaccines (PCT–GB2012–000467). SCG and TL are named inventors on a patent application covering ChAdOx1 nCoV-19 (GB2003670.3), and TL was a consultant to Vaccitech. AD has received research and consultancy income from AstraZeneca and is a named inventor to intellectual property assigned to Oxford University Innovation relating to the ChAdOx1 nCoV-19 vaccine manufacturing process. All other authors declare no competing interests. (Copyright: © 2023 Hamaluba M et al.)
Databáze:	MEDLINE
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