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

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Autor(es): dc.creatorZhu, Feng-Cai-
Autor(es): dc.creatorLi, Yu-Hua-
Autor(es): dc.creatorGuan, Xu-Hua-
Autor(es): dc.creatorHou, Li-Hua-
Autor(es): dc.creatorWang, Wen-Juan-
Autor(es): dc.creatorLi, Jing-Xin-
Autor(es): dc.creatorWu, Shi-Po-
Autor(es): dc.creatorWang, Bu-Sen-
Autor(es): dc.creatorWang, Zhao-
Autor(es): dc.creatorWang, Lei-
Autor(es): dc.creatorJia, Si-Yue-
Autor(es): dc.creatorJiang, Hu-Dachuan-
Autor(es): dc.creatorWang, Ling-
Autor(es): dc.creatorJiang, Tao-
Autor(es): dc.creatorHu, Yi-
Autor(es): dc.creatorGou, Jin-Bo-
Autor(es): dc.creatorXu, Sha-Bei-
Autor(es): dc.creatorXu, Jun-Jie-
Autor(es): dc.creatorWang, Xue-Wen-
Autor(es): dc.creatorWang, Wei-
Autor(es): dc.creatorChen, Wei-
Data de aceite: dc.date.accessioned2026-02-09T11:22:49Z-
Data de disponibilização: dc.date.available2026-02-09T11:22:49Z-
Data de envio: dc.date.issued2020-05-27-
Data de envio: dc.date.issued2020-05-27-
Data de envio: dc.date.issued2020-05-
Fonte completa do material: dc.identifierhttps://repositorio.ufla.br/handle/1/41244-
Fonte completa do material: dc.identifierhttps://www.sciencedirect.com/science/article/pii/S0140673620312083-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/capes/1139653-
Descrição: dc.descriptionBackground 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.languageen-
Publicador: dc.publisherElsevier-
Direitos: dc.rightsrestrictAccess-
???dc.source???: dc.sourceThe Lancet-
Palavras-chave: dc.subjectCOVID-19 - Vaccine-
Palavras-chave: dc.subjectRecombinant adenovirus type-5 (Ad5)-
Título: dc.titleSafety, 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.typeArtigo-
Aparece nas coleções:Repositório Institucional da Universidade Federal de Lavras (RIUFLA)

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