Immunogenicity of an adjuvanted SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019) in SARS-CoV-2-naïve and exposed individuals in a phase 2/3, double-blind, randomized study

Buntinx, Erik; Brochado, Leonardo; Borja-Tabora, Charissa; Yu, Charles; Alberto, Edison; Montellano, May Emmeline B.; Carlos, Josefina; Toloza, Leonardo Bautista; Hites, Maya; Siber, George R.; Clemens, Ralf; Ambrosino, Donna M.; Qin, Haijing; Chen, Huiling; Han, Htay Htay; Hu, Branda; Li, Ping; Baccarini, Carmen; Smolenov, Igor

doi:10.1016/j.vaccine.2023.02.017

Cited by 11 publications

(18 citation statements)

References 27 publications

(41 reference statements)

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“…In adolescents with serological evidence of prior SARS-CoV-2 exposure, there was a four-fold increase in neutralizing antibodies after one dose of SCB-2019 vaccine, whereas in SARS-CoV-2-naïve adolescents the first dose of SCB-2019 vaccine had little effect on the immunogenicity consistent with previous observations [6,8]. The magnitude of the response in pre-exposed adolescents after the first dose of SCB-2019 vaccine suggests there is a booster response on top of the immunity induced by natural exposure to SARS-CoV-2 in these individuals.…”

Section: Discussionsupporting

confidence: 89%

“…However, the neutralizing responses measured in adolescents compare well with those measured in adults from 18 to approximately 80 years of age in the phase 2/3 efficacy trial of SCB-2019 vaccine in which efficacies of 67.2%, 83.7% and 100% against any severity, moderate-to-severe and severe COVID-19, respectively, were observed [7]. In In adolescents with serological evidence of prior SARS-CoV-2 exposure, there was a fourfold increase in neutralizing antibodies after one dose of SCB-2019 vaccine, whereas in SARS-CoV-2-naïve adolescents the first dose of SCB-2019 vaccine had little effect on the immunogenicity consistent with previous observations [6,8]. The magnitude of the response in pre-exposed adolescents after the first dose of SCB-2019 vaccine suggests there is a booster response on top of the immunity induced by natural exposure to SARS-CoV-2 in these individuals.…”

Section: Discussionsupporting

confidence: 86%

“…However, the neutralizing responses measured in adolescents compare well with those measured in adults from 18 to approximately 80 years of age in the phase 2/3 efficacy trial of SCB-2019 vaccine in which efficacies of 67.2%, 83.7% and 100% against any severity, moderate-to-severe and severe COVID-19, respectively, were observed [7]. In that adult population the neutralizing GMTs at Day 36 were 224 IU/mL (95% CI: 194.0– 258.7; n = 220) and 1831 IU/mL (1546–2170; n = 118) in SARS-CoV-2-naïve and SARS-CoV-2-exposed participants, respectively [8]. The 271 IU/mL (211–348) and 982 IU/mL (881–1094) in SARS-CoV-2-naïve and SARS-CoV-2-exposed adolescents measured in the present study are consistent with those values suggesting similar efficacy would have been achieved.…”

Section: Discussionmentioning

confidence: 99%

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Safety and immunogenicity of SCB-2019, an adjuvanted, recombinant SARS-CoV-2 trimeric S-protein subunit COVID-19 vaccine in healthy 12–17 year-old adolescents

López

Bravo

Buntinx³

et al. 2023

Preprint

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We previously demonstrated efficacy of the COVID-19 vaccine candidate, SCB-2019, in adults in the SPECTRA phase 2/3 efficacy study. We extended the study to include 1278 healthy 12-17-year-old adolescents in Belgium, Colombia and the Philippines who received either two doses of SCB-2019 or placebo 21 days apart, to assess immunogenicity as neutralizing antibodies against prototype SARS-CoV-2 and variants of concern, and safety and reactogenicity as solicited and unsolicited adverse events with a comparator group of young adults (18-25 years). In participants with no evidence of prior SARS-CoV-2 infection SCB-2019 immunogenicity in adolescents was non-inferior to that in young adults; respective geometric mean neutralizing titers (GMT) against prototype SARS-CoV-2 14 days after the second vaccination were 271 IU/mL (95% CI: 211-348) and 144 IU/mL (116-178). Most adolescents (1077, 84.3%) had serologic evidence of prior SAR-CoV-2 exposure at baseline; in these seropositive adolescents neutralizing GMTs increased from 173 IU/mL (135-122) to 982 IU/mL (881-1094) after the second dose. Neutralizing titers against Delta and Omicron BA SARS-CoV-2 variants were also increased, most notably in those with prior exposure. SCB-2019 vaccine was well tolerated with generally mild or moderate, transient solicited and unsolicited adverse events that were comparable in adolescent vaccine and placebo groups except for injection site pain - reported after 20% of SCB-2019 and 7.3% of placebo injections. SCB-2019 vaccine was highly immunogenic against SARS-CoV-2 prototype and variants in adolescents, especially in those with evidence of prior exposure, with comparable immunogenicity to young adults.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionsupporting

confidence: 86%

“…However, the neutralizing responses measured in adolescents compare well with those measured in adults from 18 to approximately 80 years of age in the phase 2/3 efficacy trial of SCB-2019 vaccine in which efficacies of 67.2%, 83.7% and 100% against any severity, moderate-to-severe and severe COVID-19, respectively, were observed [7]. In that adult population the neutralizing GMTs at Day 36 were 224 IU/mL (95% CI: 194.0– 258.7; n = 220) and 1831 IU/mL (1546–2170; n = 118) in SARS-CoV-2-naïve and SARS-CoV-2-exposed participants, respectively [8]. The 271 IU/mL (211–348) and 982 IU/mL (881–1094) in SARS-CoV-2-naïve and SARS-CoV-2-exposed adolescents measured in the present study are consistent with those values suggesting similar efficacy would have been achieved.…”

Section: Discussionmentioning

confidence: 99%

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Safety and immunogenicity of SCB-2019, an adjuvanted, recombinant SARS-CoV-2 trimeric S-protein subunit COVID-19 vaccine in healthy 12–17 year-old adolescents

López

Bravo

Buntinx³

et al. 2023

Preprint

Self Cite

View full text Add to dashboard Cite

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“…Strong humoral and cellular responses and high titers of neutralizing antibodies were obtained in a phase I study [ 37 ]. In phase II/III, SCB-2019 elicited immunogenicity and cross-reactivity against SARS-CoV-2 [ 38 ].…”

Section: Covid-19 Vaccinesmentioning

confidence: 99%

“…For example, the efficacy of the whole-virus vaccine VLA2001 against the delta and omicron variants was improved after both homologous and ChAdOx1 nCoV-19 heterologous booster immunizations [ 174 ]. In another study, it was demonstrated that individuals originally vaccinated with mRNA or Ad-based vaccines, who received a booster immunization with the preS dTM-AS03 protein subunit vaccine carrying the beta variant S protein, showed robust neutralizing antibody responses against several SARS-CoV-2 VoC [ 38 ]. The booster formulation induced cross-reacting neutralizing antibodies against the beta (B.1.351) and omicron (BA.1, BA.2, and BA.4/5) variants [ 38 ].…”

Section: Sars-cov-2 Variants and Vaccine Efficacymentioning

confidence: 99%

COVID-19 Vaccines: Where Did We Stand at the End of 2023?

Lundstrom

2024

Viruses

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Vaccine development against SARS-CoV-2 has been highly successful in slowing down the COVID-19 pandemic. A wide spectrum of approaches including vaccines based on whole viruses, protein subunits and peptides, viral vectors, and nucleic acids has been developed in parallel. For all types of COVID-19 vaccines, good safety and efficacy have been obtained in both preclinical animal studies and in clinical trials in humans. Moreover, emergency use authorization has been granted for the major types of COVID-19 vaccines. Although high safety has been demonstrated, rare cases of severe adverse events have been detected after global mass vaccinations. Emerging SARS-CoV-2 variants possessing enhanced infectivity have affected vaccine protection efficacy requiring re-design and re-engineering of novel COVID-19 vaccine candidates. Furthermore, insight is given into preparedness against emerging SARS-CoV-2 variants.

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