Wellcome Open Research (Nov 2023)

Safety and immunogenicity of ChAdOx1 nCoV-19 (AZD1222) vaccine in adults in Kenya: a phase 1/2 single-blind, randomised controlled trial [version 2; peer review: 2 approved]

  • Mainga Hamaluba,
  • Cynthia Mauncho,
  • Neema Mturi,
  • Henry Karanja,
  • Daisy Mugo,
  • James Nyagwange,
  • Caroline Ngetsa,
  • Bernadette Kutima,
  • Samuel Sang,
  • John N. Gitonga,
  • Benjamin Tsofa,
  • Philip Bejon,
  • Naomi Kamau,
  • George Warimwe,
  • Benedict Orindi,
  • Irene Njau,
  • Mwaganyuma Mwatasa,
  • Lynette Ochola-Oyier,
  • Donwilliams Omuoyo,
  • Elizaphan Oloo,
  • Stanley Cheruiyot,
  • Eunice W. Nduati,
  • Roselyne Namayi,
  • Anthony Etyang,
  • Nadia Aliyan,
  • Adrian Hill,
  • Amy Boyd,
  • Marianne Munene,
  • Alexander Douglas,
  • Amek Nyaguara,
  • Sarah Gilbert,
  • Daniel Wright,
  • Teresa Lambe,
  • Charles Agoti,
  • Kadondi Kasera,
  • Alun Davies,
  • Andrew Pollard,
  • Noni Mumba

Journal volume & issue
Vol. 8

Abstract

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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 28th October 2020 and 19th 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)

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