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| Metadados | Descrição | Idioma |
|---|---|---|
| Autor(es): dc.creator | Zhu, Feng-Cai | - |
| Autor(es): dc.creator | Li, Yu-Hua | - |
| Autor(es): dc.creator | Guan, Xu-Hua | - |
| Autor(es): dc.creator | Hou, Li-Hua | - |
| Autor(es): dc.creator | Wang, Wen-Juan | - |
| Autor(es): dc.creator | Li, Jing-Xin | - |
| Autor(es): dc.creator | Wu, Shi-Po | - |
| Autor(es): dc.creator | Wang, Bu-Sen | - |
| Autor(es): dc.creator | Wang, Zhao | - |
| Autor(es): dc.creator | Wang, Lei | - |
| Autor(es): dc.creator | Jia, Si-Yue | - |
| Autor(es): dc.creator | Jiang, Hu-Dachuan | - |
| Autor(es): dc.creator | Wang, Ling | - |
| Autor(es): dc.creator | Jiang, Tao | - |
| Autor(es): dc.creator | Hu, Yi | - |
| Autor(es): dc.creator | Gou, Jin-Bo | - |
| Autor(es): dc.creator | Xu, Sha-Bei | - |
| Autor(es): dc.creator | Xu, Jun-Jie | - |
| Autor(es): dc.creator | Wang, Xue-Wen | - |
| Autor(es): dc.creator | Wang, Wei | - |
| Autor(es): dc.creator | Chen, Wei | - |
| Data de aceite: dc.date.accessioned | 2026-02-09T11:22:49Z | - |
| Data de disponibilização: dc.date.available | 2026-02-09T11:22:49Z | - |
| Data de envio: dc.date.issued | 2020-05-27 | - |
| Data de envio: dc.date.issued | 2020-05-27 | - |
| Data de envio: dc.date.issued | 2020-05 | - |
| Fonte completa do material: dc.identifier | https://repositorio.ufla.br/handle/1/41244 | - |
| Fonte completa do material: dc.identifier | https://www.sciencedirect.com/science/article/pii/S0140673620312083 | - |
| Fonte: dc.identifier.uri | http://educapes.capes.gov.br/handle/capes/1139653 | - |
| Descrição: dc.description | Background A vaccine to protect against COVID-19 is urgently needed. We aimed to assess the safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 (Ad5) vectored COVID-19 vaccine expressing the spike glycoprotein of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain. Methods We did a dose-escalation, single-centre, open-label, non-randomised, phase 1 trial of an Ad5 vectored COVID-19 vaccine in Wuhan, China. Healthy adults aged between 18 and 60 years were sequentially enrolled and allocated to one of three dose groups (5 × 1010, 1 × 1011, and 1·5 × 1011 viral particles) to receive an intramuscular injection of vaccine. The primary outcome was adverse events in the 7 days post-vaccination. Safety was assessed over 28 days post-vaccination. Specific antibodies were measured with ELISA, and the neutralising antibody responses induced by vaccination were detected with SARS-CoV-2 virus neutralisation and pseudovirus neutralisation tests. T-cell responses were assessed by enzyme-linked immunospot and flow-cytometry assays. This study is registered with ClinicalTrials.gov, NCT04313127. Findings Between March 16 and March 27, 2020, we screened 195 individuals for eligibility. Of them, 108 participants (51% male, 49% female; mean age 36·3 years) were recruited and received the low dose (n=36), middle dose (n=36), or high dose (n=36) of the vaccine. All enrolled participants were included in the analysis. At least one adverse reaction within the first 7 days after the vaccination was reported in 30 (83%) participants in the low dose group, 30 (83%) participants in the middle dose group, and 27 (75%) participants in the high dose group. The most common injection site adverse reaction was pain, which was reported in 58 (54%) vaccine recipients, and the most commonly reported systematic adverse reactions were fever (50 [46%]), fatigue (47 [44%]), headache (42 [39%]), and muscle pain (18 [17%]. Most adverse reactions that were reported in all dose groups were mild or moderate in severity. No serious adverse event was noted within 28 days post-vaccination. ELISA antibodies and neutralising antibodies increased significantly at day 14, and peaked 28 days post-vaccination. Specific T-cell response peaked at day 14 post-vaccination. Interpretation The Ad5 vectored COVID-19 vaccine is tolerable and immunogenic at 28 days post-vaccination. Humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults, and rapid specific T-cell responses were noted from day 14 post-vaccination. Our findings suggest that the Ad5 vectored COVID-19 vaccine warrants further investigation. | - |
| Idioma: dc.language | en | - |
| Publicador: dc.publisher | Elsevier | - |
| Direitos: dc.rights | restrictAccess | - |
| ???dc.source???: dc.source | The Lancet | - |
| Palavras-chave: dc.subject | COVID-19 - Vaccine | - |
| Palavras-chave: dc.subject | Recombinant adenovirus type-5 (Ad5) | - |
| Título: dc.title | Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial | - |
| Tipo de arquivo: dc.type | Artigo | - |
| Aparece nas coleções: | Repositório Institucional da Universidade Federal de Lavras (RIUFLA) | |
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