Safety and immunogenicity of ChAdOx1 nCoV-19 (AZD1222) vaccine in adults in Kenya: a phase 1/2 single-blind, randomised controlled trial.
COVID-19
ChAdOx1-nCoV-19
Kenya
vaccine
Journal
Wellcome open research
ISSN: 2398-502X
Titre abrégé: Wellcome Open Res
Pays: England
ID NLM: 101696457
Informations de publication
Date de publication:
2023
2023
Historique:
accepted:
22
11
2023
medline:
6
5
2024
pubmed:
6
5
2024
entrez:
6
5
2024
Statut:
epublish
Résumé
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. 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. Between 28 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. PACTR202005681895696 (11/05/2020).
Sections du résumé
Background
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
Between 28
Conclusions
UNASSIGNED
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
UNASSIGNED
PACTR202005681895696 (11/05/2020).
Identifiants
pubmed: 38707489
doi: 10.12688/wellcomeopenres.19150.2
pmc: PMC11066537
doi:
Types de publication
Journal Article
Langues
eng
Pagination
182Informations de copyright
Copyright: © 2023 Hamaluba M et al.
Déclaration de conflit d'intérêts
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.