Immunogenicity, safety and reactogenicity of heterologous (third dose) booster vaccination with a full or fractional dose of two different COVID-19 vaccines: A phase 4, single-blind, randomized controlled trial in adults
<p>In this phase 4 study we assessed boosting with fractional doses of heterologous COVID-19 vaccines in Brazilian adults primed with two doses of CoronaVac (Sinovac/Butantan, São Paulo, Brazil) at least 4 months previously. Participants received either full-dose of ChAdOx1-S (Group...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
Taylor and Francis
2023
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| _version_ | 1797111225286393856 |
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| author | Costa Clemens, SA Marchevsky, N Kelly, S Felle, S Eldawi, A Rajasingam, R Mahmud, R Lambe, T Voysey, M Gonzalez, I Milan, EP Justino, MC Bibi, S Aley, P Clemens, R Pollard, AJ |
| author_facet | Costa Clemens, SA Marchevsky, N Kelly, S Felle, S Eldawi, A Rajasingam, R Mahmud, R Lambe, T Voysey, M Gonzalez, I Milan, EP Justino, MC Bibi, S Aley, P Clemens, R Pollard, AJ |
| author_sort | Costa Clemens, SA |
| collection | OXFORD |
| description | <p>In this phase 4 study we assessed boosting with fractional doses of heterologous COVID-19 vaccines in Brazilian adults primed with two doses of CoronaVac (Sinovac/Butantan, São Paulo, Brazil) at least 4 months previously. Participants received either full-dose of ChAdOx1-S (Group 1, <em>n</em> = 232), a half dose of ChAdOx1-S (Group 2, <em>n</em> = 236), or a half dose of BNT162b2 (Group 3, <em>n</em> = 234). The primary objective was to show 80% seroresponse rates (SRR) 28 d after vaccination measured as IgG antibodies against a prototype SARS-CoV-2 spike-protein. Safety was assessed as solicited and unsolicited adverse events. At baseline all participants were seropositive, with high IgG titers overall. SRR at Day 28 were 34.3%, 27.1% and 71.2%, respectively, not meeting the primary objective of 80%, despite robust immune responses in all three groups with geometric mean-fold rise (GMFR) in IgG titers of 3.39, 2.99 and 7.42, respectively. IgG immune responses with similar GMFR were also observed against SARS-CoV-2 variants, Alpha, Beta, Delta, Gamma and D614G. In subsets (<em>n</em> = 35) of participants GMFR of neutralizing immune responses against live prototype SARS-CoV-2 virus and Omicron BA.2 were similar to the IgG responses as were pseudo-neutralizing responses against SARS-CoV-2 prototype and Omicron BA.4/5 variants. All vaccinations were well tolerated with no vaccine-related serious adverse events and mainly transient mild-to-moderate local and systemic reactogenicity. Heterologous boosting with full or half doses of ChAdOx1-S or a half dose of BNT162b2 was safe and immunogenic in CoronaVac-primed adults, but seroresponse rates were limited by high baseline immunity.</p> |
| first_indexed | 2024-03-07T08:07:18Z |
| format | Journal article |
| id | oxford-uuid:e5c10a51-cc40-4b73-be80-a4067d51251c |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T08:07:18Z |
| publishDate | 2023 |
| publisher | Taylor and Francis |
| record_format | dspace |
| spelling | oxford-uuid:e5c10a51-cc40-4b73-be80-a4067d51251c2023-11-02T06:29:57ZImmunogenicity, safety and reactogenicity of heterologous (third dose) booster vaccination with a full or fractional dose of two different COVID-19 vaccines: A phase 4, single-blind, randomized controlled trial in adultsJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:e5c10a51-cc40-4b73-be80-a4067d51251cEnglishSymplectic ElementsTaylor and Francis2023Costa Clemens, SAMarchevsky, NKelly, SFelle, SEldawi, ARajasingam, RMahmud, RLambe, TVoysey, MGonzalez, IMilan, EPJustino, MCBibi, SAley, PClemens, RPollard, AJ<p>In this phase 4 study we assessed boosting with fractional doses of heterologous COVID-19 vaccines in Brazilian adults primed with two doses of CoronaVac (Sinovac/Butantan, São Paulo, Brazil) at least 4 months previously. Participants received either full-dose of ChAdOx1-S (Group 1, <em>n</em> = 232), a half dose of ChAdOx1-S (Group 2, <em>n</em> = 236), or a half dose of BNT162b2 (Group 3, <em>n</em> = 234). The primary objective was to show 80% seroresponse rates (SRR) 28 d after vaccination measured as IgG antibodies against a prototype SARS-CoV-2 spike-protein. Safety was assessed as solicited and unsolicited adverse events. At baseline all participants were seropositive, with high IgG titers overall. SRR at Day 28 were 34.3%, 27.1% and 71.2%, respectively, not meeting the primary objective of 80%, despite robust immune responses in all three groups with geometric mean-fold rise (GMFR) in IgG titers of 3.39, 2.99 and 7.42, respectively. IgG immune responses with similar GMFR were also observed against SARS-CoV-2 variants, Alpha, Beta, Delta, Gamma and D614G. In subsets (<em>n</em> = 35) of participants GMFR of neutralizing immune responses against live prototype SARS-CoV-2 virus and Omicron BA.2 were similar to the IgG responses as were pseudo-neutralizing responses against SARS-CoV-2 prototype and Omicron BA.4/5 variants. All vaccinations were well tolerated with no vaccine-related serious adverse events and mainly transient mild-to-moderate local and systemic reactogenicity. Heterologous boosting with full or half doses of ChAdOx1-S or a half dose of BNT162b2 was safe and immunogenic in CoronaVac-primed adults, but seroresponse rates were limited by high baseline immunity.</p> |
| spellingShingle | Costa Clemens, SA Marchevsky, N Kelly, S Felle, S Eldawi, A Rajasingam, R Mahmud, R Lambe, T Voysey, M Gonzalez, I Milan, EP Justino, MC Bibi, S Aley, P Clemens, R Pollard, AJ Immunogenicity, safety and reactogenicity of heterologous (third dose) booster vaccination with a full or fractional dose of two different COVID-19 vaccines: A phase 4, single-blind, randomized controlled trial in adults |
| title | Immunogenicity, safety and reactogenicity of heterologous (third dose) booster vaccination with a full or fractional dose of two different COVID-19 vaccines: A phase 4, single-blind, randomized controlled trial in adults |
| title_full | Immunogenicity, safety and reactogenicity of heterologous (third dose) booster vaccination with a full or fractional dose of two different COVID-19 vaccines: A phase 4, single-blind, randomized controlled trial in adults |
| title_fullStr | Immunogenicity, safety and reactogenicity of heterologous (third dose) booster vaccination with a full or fractional dose of two different COVID-19 vaccines: A phase 4, single-blind, randomized controlled trial in adults |
| title_full_unstemmed | Immunogenicity, safety and reactogenicity of heterologous (third dose) booster vaccination with a full or fractional dose of two different COVID-19 vaccines: A phase 4, single-blind, randomized controlled trial in adults |
| title_short | Immunogenicity, safety and reactogenicity of heterologous (third dose) booster vaccination with a full or fractional dose of two different COVID-19 vaccines: A phase 4, single-blind, randomized controlled trial in adults |
| title_sort | immunogenicity safety and reactogenicity of heterologous third dose booster vaccination with a full or fractional dose of two different covid 19 vaccines a phase 4 single blind randomized controlled trial in adults |
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