tetano
Editor, Senior Moderator
Wellcome Open Res
. 2023 Nov 27:8:182.
doi: 10.12688/wellcomeopenres.19150.2. eCollection 2023. Safety and immunogenicity of ChAdOx1 nCoV-19 (AZD1222) vaccine in adults in Kenya: a phase 1/2 single-blind, randomised controlled trial
Mainga Hamaluba[SUP] 1 [/SUP], Samuel Sang[SUP] 1 [/SUP], Benedict Orindi[SUP] 1 [/SUP], Irene Njau[SUP] 1 [/SUP], Henry Karanja[SUP] 1 [/SUP], Naomi Kamau[SUP] 1 [/SUP], John N Gitonga[SUP] 1 [/SUP], Daisy Mugo[SUP] 1 [/SUP], Daniel Wright[SUP] 2 [/SUP], James Nyagwange[SUP] 1 [/SUP], Bernadette Kutima[SUP] 1 [/SUP], Donwilliams Omuoyo[SUP] 1 [/SUP], Mwaganyuma Mwatasa[SUP] 1 [/SUP], Caroline Ngetsa[SUP] 1 [/SUP], Charles Agoti[SUP] 1 [/SUP], Stanley Cheruiyot[SUP] 1 [/SUP], Amek Nyaguara[SUP] 1 [/SUP], Marianne Munene[SUP] 1 [/SUP], Neema Mturi[SUP] 1 [/SUP], Elizaphan Oloo[SUP] 1 [/SUP], Lynette Ochola-Oyier[SUP] 1 [/SUP], Noni Mumba[SUP] 1 [/SUP], Cynthia Mauncho[SUP] 1 [/SUP], Roselyne Namayi[SUP] 1 [/SUP], Alun Davies[SUP] 1 3 [/SUP], Benjamin Tsofa[SUP] 1 [/SUP], Eunice W Nduati[SUP] 1 [/SUP], Nadia Aliyan[SUP] 4 [/SUP], Kadondi Kasera[SUP] 4 [/SUP], Anthony Etyang[SUP] 1 [/SUP], Amy Boyd[SUP] 5 [/SUP], Adrian Hill[SUP] 5 [/SUP], Sarah Gilbert[SUP] 6 [/SUP], Alexander Douglas[SUP] 5 [/SUP], Andrew Pollard[SUP] 2 [/SUP], Philip Bejon[SUP] 1 3 [/SUP], Teresa Lambe[SUP] 2 6 [/SUP], George Warimwe[SUP] 1 3 [/SUP]; COV004 Vaccine Trial Group
Affiliations
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 [SUP]th[/SUP] October 2020 and 19 [SUP]th[/SUP] 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).
Keywords: COVID-19; ChAdOx1-nCoV-19; Kenya; vaccine.
. 2023 Nov 27:8:182.
doi: 10.12688/wellcomeopenres.19150.2. eCollection 2023. Safety and immunogenicity of ChAdOx1 nCoV-19 (AZD1222) vaccine in adults in Kenya: a phase 1/2 single-blind, randomised controlled trial
Mainga Hamaluba[SUP] 1 [/SUP], Samuel Sang[SUP] 1 [/SUP], Benedict Orindi[SUP] 1 [/SUP], Irene Njau[SUP] 1 [/SUP], Henry Karanja[SUP] 1 [/SUP], Naomi Kamau[SUP] 1 [/SUP], John N Gitonga[SUP] 1 [/SUP], Daisy Mugo[SUP] 1 [/SUP], Daniel Wright[SUP] 2 [/SUP], James Nyagwange[SUP] 1 [/SUP], Bernadette Kutima[SUP] 1 [/SUP], Donwilliams Omuoyo[SUP] 1 [/SUP], Mwaganyuma Mwatasa[SUP] 1 [/SUP], Caroline Ngetsa[SUP] 1 [/SUP], Charles Agoti[SUP] 1 [/SUP], Stanley Cheruiyot[SUP] 1 [/SUP], Amek Nyaguara[SUP] 1 [/SUP], Marianne Munene[SUP] 1 [/SUP], Neema Mturi[SUP] 1 [/SUP], Elizaphan Oloo[SUP] 1 [/SUP], Lynette Ochola-Oyier[SUP] 1 [/SUP], Noni Mumba[SUP] 1 [/SUP], Cynthia Mauncho[SUP] 1 [/SUP], Roselyne Namayi[SUP] 1 [/SUP], Alun Davies[SUP] 1 3 [/SUP], Benjamin Tsofa[SUP] 1 [/SUP], Eunice W Nduati[SUP] 1 [/SUP], Nadia Aliyan[SUP] 4 [/SUP], Kadondi Kasera[SUP] 4 [/SUP], Anthony Etyang[SUP] 1 [/SUP], Amy Boyd[SUP] 5 [/SUP], Adrian Hill[SUP] 5 [/SUP], Sarah Gilbert[SUP] 6 [/SUP], Alexander Douglas[SUP] 5 [/SUP], Andrew Pollard[SUP] 2 [/SUP], Philip Bejon[SUP] 1 3 [/SUP], Teresa Lambe[SUP] 2 6 [/SUP], George Warimwe[SUP] 1 3 [/SUP]; COV004 Vaccine Trial Group
Affiliations
- PMID: 38707489
- PMCID: PMC11066537
- DOI: 10.12688/wellcomeopenres.19150.2
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 [SUP]th[/SUP] October 2020 and 19 [SUP]th[/SUP] 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).
Keywords: COVID-19; ChAdOx1-nCoV-19; Kenya; vaccine.