دورية أكاديمية
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
| العنوان: | 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 |
|---|---|
| المؤلفون: | Pio Lopez, Lulu Bravo, Erik Buntinx, Charissa Borja-Tabora, Hector Velasquez, Edith Johana Rodriquez, Camilo A. Rodriguez, Josefina Carlos, May Emmeline B. Montellano, Edison R. Alberto, Milagros Salvani-Bautista, Yung Huang, Branda Hu, Ping Li, Htay Htay Han, Carmen Baccarini, Igor Smolenov |
| المصدر: | Human Vaccines & Immunotherapeutics, Vol 19, Iss 1 (2023) |
| بيانات النشر: | Taylor & Francis Group, 2023. |
| سنة النشر: | 2023 |
| المجموعة: | LCC:Immunologic diseases. Allergy LCC:Therapeutics. Pharmacology |
| مصطلحات موضوعية: | covid-19, vaccine, scb-2019, adolescents, reactogenicity, immunogenicity, Immunologic diseases. Allergy, RC581-607, Therapeutics. Pharmacology, RM1-950 |
| الوصف: | We previously demonstrated the 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. Clinical trial registration: EudraCT 2020–004272–17; ClinicalTrials.gov NCT04672395. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 2164-5515 2164-554X 21645515 |
| Relation: | https://doaj.org/toc/2164-5515; https://doaj.org/toc/2164-554X |
| DOI: | 10.1080/21645515.2023.2206359 |
| URL الوصول: | https://doaj.org/article/daaa0d257f4f4c44bdf1eb2e0340d2f8 |
| رقم الأكسشن: | edsdoj.0d257f4f4c44bdf1eb2e0340d2f8 |
| قاعدة البيانات: | Directory of Open Access Journals |
PDF full text from Publisher 
Full Text Finder | تدمد: | 21645515 2164554X |
|---|---|
| DOI: | 10.1080/21645515.2023.2206359 |