Homologous and heterologous boosting of the Chadox1-S1-S COVID-19 vaccine with the SCB-2019 vaccine candidate: a randomized, controlled, phase 2 study

<p><strong>Background: </strong>Ongoing outbreaks of coronavirus disease 2019 (COVID-19) are driven by waning immunity following primary immunizations and emergence of new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants that escape vaccine-induced neutralizing...

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Main Authors: Costa Clemens, SA, Milan, EP, Sprinz, E, Neto, JC, Pacciarini, F, Li, P, Chen, HL, Smolenov, I, Pollard, A, Clemens, R
פורמט: Journal article
שפה:English
יצא לאור: Oxford University Press 2022
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author Costa Clemens, SA
Milan, EP
Sprinz, E
Neto, JC
Pacciarini, F
Li, P
Chen, HL
Smolenov, I
Pollard, A
Clemens, R
author_facet Costa Clemens, SA
Milan, EP
Sprinz, E
Neto, JC
Pacciarini, F
Li, P
Chen, HL
Smolenov, I
Pollard, A
Clemens, R
author_sort Costa Clemens, SA
collection OXFORD
description <p><strong>Background: </strong>Ongoing outbreaks of coronavirus disease 2019 (COVID-19) are driven by waning immunity following primary immunizations and emergence of new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants that escape vaccine-induced neutralizing antibodies. It has been suggested that heterologous boosters could enhance and potentially maintain population immunity.</p> <p><strong>Methods: </strong>We assessed the immunogenicity and reactogenicity of booster doses of different formulations of aluminium hydroxide&ndash;adjuvanted SCB-2019 vaccine (9 &mu;g of SCB-2019, with or without CpG-1018 adjuvant, or 30 &mu;g of SCB-2019 with CpG-1018) in Brazilian adults primed with ChAdOx1-S vector vaccine. S-protein antibodies and ACE2-binding inhibition were measured by enzyme-linked immunosorbent assay (ELISA) on days 1, 15, and 29. Participants self-reported solicited adverse events and reactions.</p> <p><strong>Results: </strong>All SCB-2019 formulations increased S-protein ELISA antibodies and ACE2 binding inhibition to a greater extent than ChAdOx1-S. After 30 &mu;g of SCB-2019&thinsp;+&thinsp;CpG&thinsp;+&thinsp;aluminium hydroxide, titers against wild-type S-protein were significantly higher than after ChAdOx1-S on days 15 and 29, as were titers of neutralizing antibodies against the wild-type strain and Beta, Gamma, Delta, and Omicron variants. Boosting with SCB-2019 or ChAdOx1-S was well tolerated, with no vaccine-related serious or severe adverse events.</p> <p><strong>Conclusions: </strong>Boosting ChAdOx1-S-primed adults with SCB-2019 induced higher levels of antibodies against a wild-type strain and SARS-CoV-2 variants than a homologous ChAdOx1-S booster, with the highest responses being with the 30-&mu;g SCB-2019&thinsp;+&thinsp;CpG&thinsp;+&thinsp;aluminium hydroxide formulation.</p> <p><strong>Clinical Trials Registration: </strong>NCT05087368</p>
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spelling oxford-uuid:6bb1cd6b-b705-4286-b1a3-ee3625a8924a2023-08-10T15:22:04ZHomologous and heterologous boosting of the Chadox1-S1-S COVID-19 vaccine with the SCB-2019 vaccine candidate: a randomized, controlled, phase 2 studyJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:6bb1cd6b-b705-4286-b1a3-ee3625a8924aEnglishSymplectic ElementsOxford University Press2022Costa Clemens, SAMilan, EPSprinz, ENeto, JCPacciarini, FLi, PChen, HLSmolenov, IPollard, AClemens, R<p><strong>Background: </strong>Ongoing outbreaks of coronavirus disease 2019 (COVID-19) are driven by waning immunity following primary immunizations and emergence of new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants that escape vaccine-induced neutralizing antibodies. It has been suggested that heterologous boosters could enhance and potentially maintain population immunity.</p> <p><strong>Methods: </strong>We assessed the immunogenicity and reactogenicity of booster doses of different formulations of aluminium hydroxide&ndash;adjuvanted SCB-2019 vaccine (9 &mu;g of SCB-2019, with or without CpG-1018 adjuvant, or 30 &mu;g of SCB-2019 with CpG-1018) in Brazilian adults primed with ChAdOx1-S vector vaccine. S-protein antibodies and ACE2-binding inhibition were measured by enzyme-linked immunosorbent assay (ELISA) on days 1, 15, and 29. Participants self-reported solicited adverse events and reactions.</p> <p><strong>Results: </strong>All SCB-2019 formulations increased S-protein ELISA antibodies and ACE2 binding inhibition to a greater extent than ChAdOx1-S. After 30 &mu;g of SCB-2019&thinsp;+&thinsp;CpG&thinsp;+&thinsp;aluminium hydroxide, titers against wild-type S-protein were significantly higher than after ChAdOx1-S on days 15 and 29, as were titers of neutralizing antibodies against the wild-type strain and Beta, Gamma, Delta, and Omicron variants. Boosting with SCB-2019 or ChAdOx1-S was well tolerated, with no vaccine-related serious or severe adverse events.</p> <p><strong>Conclusions: </strong>Boosting ChAdOx1-S-primed adults with SCB-2019 induced higher levels of antibodies against a wild-type strain and SARS-CoV-2 variants than a homologous ChAdOx1-S booster, with the highest responses being with the 30-&mu;g SCB-2019&thinsp;+&thinsp;CpG&thinsp;+&thinsp;aluminium hydroxide formulation.</p> <p><strong>Clinical Trials Registration: </strong>NCT05087368</p>
spellingShingle Costa Clemens, SA
Milan, EP
Sprinz, E
Neto, JC
Pacciarini, F
Li, P
Chen, HL
Smolenov, I
Pollard, A
Clemens, R
Homologous and heterologous boosting of the Chadox1-S1-S COVID-19 vaccine with the SCB-2019 vaccine candidate: a randomized, controlled, phase 2 study
title Homologous and heterologous boosting of the Chadox1-S1-S COVID-19 vaccine with the SCB-2019 vaccine candidate: a randomized, controlled, phase 2 study
title_full Homologous and heterologous boosting of the Chadox1-S1-S COVID-19 vaccine with the SCB-2019 vaccine candidate: a randomized, controlled, phase 2 study
title_fullStr Homologous and heterologous boosting of the Chadox1-S1-S COVID-19 vaccine with the SCB-2019 vaccine candidate: a randomized, controlled, phase 2 study
title_full_unstemmed Homologous and heterologous boosting of the Chadox1-S1-S COVID-19 vaccine with the SCB-2019 vaccine candidate: a randomized, controlled, phase 2 study
title_short Homologous and heterologous boosting of the Chadox1-S1-S COVID-19 vaccine with the SCB-2019 vaccine candidate: a randomized, controlled, phase 2 study
title_sort homologous and heterologous boosting of the chadox1 s1 s covid 19 vaccine with the scb 2019 vaccine candidate a randomized controlled phase 2 study
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