Use este identificador para citar ou linkar para este item: http://repositorio.ufla.br/jspui/handle/1/41244
Título : 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
Autor: Zhu, Feng-Cai
Li, Yu-Hua
Guan, Xu-Hua
Hou, Li-Hua
Wang, Wen-Juan
Li, Jing-Xin
Wu, Shi-Po
Wang, Bu-Sen
Wang, Zhao
Wang, Lei
Jia, Si-Yue
Jiang, Hu-Dachuan
Wang, Ling
Jiang, Tao
Hu, Yi
Gou, Jin-Bo
Xu, Sha-Bei
Xu, Jun-Jie
Wang, Xue-Wen
Wang, Wei
Chen, Wei
Palavras-chave: COVID-19 - Vaccine
Recombinant adenovirus type-5 (Ad5)
Publicador: Elsevier
Data da publicação: Mai-2020
Referência: ZHU, F.-C. et al. 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. The Lancet, [S.l.], v. 395, n. 10240, p. 1845-1854, June 2020.
Abstract: 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.
URI: https://www.sciencedirect.com/science/article/pii/S0140673620312083
http://repositorio.ufla.br/jspui/handle/1/41244
Idioma: en_US
Aparece nas coleções:FCS - Artigos sobre Coronavirus Disease 2019 (COVID-19)

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