Safety and immunogenicity of ChAdOx1 nCoV-19 (AZD1222) vaccine in adults in Kenya: a phase 1/2 single-blind, randomised controlled trial
<strong>Background: </strong>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 tr...
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| Format: | Journal article |
| Language: | English |
| Published: |
F1000Research
2023
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| _version_ | 1826314316862717952 |
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| author | Hamaluba, M Sang, S Orindi, B Njau, I Karanja, H Kamau, N Gitonga, J Mugo, D Wright, D Nyagwange, J Kutima, B Omuoyo, D Mwatasa, M Ngetsa, C Agoti, C Cheruiyot, S Nyaguara, A Munene, M Mturi, N Oloo, E Ochola-Oyier, L Mumba, N Mauncho, C Namayi, R Davies, A Tsofa, B Nduati, E Aliyan, N Kasera, K Etyang, A Boyd, A Hill, A Gilbert, S Douglas, A Pollard, A Bejon, P Lambe, T Warimwe, G |
| author2 | COV004 Vaccine Trial Group |
| author_facet | COV004 Vaccine Trial Group Hamaluba, M Sang, S Orindi, B Njau, I Karanja, H Kamau, N Gitonga, J Mugo, D Wright, D Nyagwange, J Kutima, B Omuoyo, D Mwatasa, M Ngetsa, C Agoti, C Cheruiyot, S Nyaguara, A Munene, M Mturi, N Oloo, E Ochola-Oyier, L Mumba, N Mauncho, C Namayi, R Davies, A Tsofa, B Nduati, E Aliyan, N Kasera, K Etyang, A Boyd, A Hill, A Gilbert, S Douglas, A Pollard, A Bejon, P Lambe, T Warimwe, G |
| author_sort | Hamaluba, M |
| collection | OXFORD |
| description | <strong>Background: </strong>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.<br><strong>
Methods: </strong>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.<br><strong>
Results: </strong>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). <br><strong>
Conclusions: </strong>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.<br><strong>
Pan-African Clinical Trials Registration: </strong>PACTR202005681895696 (11/05/2020) |
| first_indexed | 2024-03-07T08:26:53Z |
| format | Journal article |
| id | oxford-uuid:e3632b85-1300-4969-9496-a8361a360e4a |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-09-25T04:30:36Z |
| publishDate | 2023 |
| publisher | F1000Research |
| record_format | dspace |
| spelling | oxford-uuid:e3632b85-1300-4969-9496-a8361a360e4a2024-08-27T11:24:48ZSafety and immunogenicity of ChAdOx1 nCoV-19 (AZD1222) vaccine in adults in Kenya: a phase 1/2 single-blind, randomised controlled trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:e3632b85-1300-4969-9496-a8361a360e4aEnglishSymplectic ElementsF1000Research2023Hamaluba, MSang, SOrindi, BNjau, IKaranja, HKamau, NGitonga, JMugo, DWright, DNyagwange, JKutima, BOmuoyo, DMwatasa, MNgetsa, CAgoti, CCheruiyot, SNyaguara, AMunene, MMturi, NOloo, EOchola-Oyier, LMumba, NMauncho, CNamayi, RDavies, ATsofa, BNduati, EAliyan, NKasera, KEtyang, ABoyd, AHill, AGilbert, SDouglas, APollard, ABejon, PLambe, TWarimwe, GCOV004 Vaccine Trial Group<strong>Background: </strong>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.<br><strong> Methods: </strong>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.<br><strong> Results: </strong>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). <br><strong> Conclusions: </strong>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.<br><strong> Pan-African Clinical Trials Registration: </strong>PACTR202005681895696 (11/05/2020) |
| spellingShingle | Hamaluba, M Sang, S Orindi, B Njau, I Karanja, H Kamau, N Gitonga, J Mugo, D Wright, D Nyagwange, J Kutima, B Omuoyo, D Mwatasa, M Ngetsa, C Agoti, C Cheruiyot, S Nyaguara, A Munene, M Mturi, N Oloo, E Ochola-Oyier, L Mumba, N Mauncho, C Namayi, R Davies, A Tsofa, B Nduati, E Aliyan, N Kasera, K Etyang, A Boyd, A Hill, A Gilbert, S Douglas, A Pollard, A Bejon, P Lambe, T Warimwe, G Safety and immunogenicity of ChAdOx1 nCoV-19 (AZD1222) vaccine in adults in Kenya: a phase 1/2 single-blind, randomised controlled trial |
| title | Safety and immunogenicity of ChAdOx1 nCoV-19 (AZD1222) vaccine in adults in Kenya: a phase 1/2 single-blind, randomised controlled trial |
| title_full | Safety and immunogenicity of ChAdOx1 nCoV-19 (AZD1222) vaccine in adults in Kenya: a phase 1/2 single-blind, randomised controlled trial |
| title_fullStr | Safety and immunogenicity of ChAdOx1 nCoV-19 (AZD1222) vaccine in adults in Kenya: a phase 1/2 single-blind, randomised controlled trial |
| title_full_unstemmed | Safety and immunogenicity of ChAdOx1 nCoV-19 (AZD1222) vaccine in adults in Kenya: a phase 1/2 single-blind, randomised controlled trial |
| title_short | Safety and immunogenicity of ChAdOx1 nCoV-19 (AZD1222) vaccine in adults in Kenya: a phase 1/2 single-blind, randomised controlled trial |
| title_sort | safety and immunogenicity of chadox1 ncov 19 azd1222 vaccine in adults in kenya a phase 1 2 single blind randomised controlled trial |
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