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A First-in-Human Trial to Evaluate the Safety and Immunogenicity of a G Protein-Based Recombinant Respiratory Syncytial Virus Vaccine in Healthy Adults 18–45 Years of Age

Background: With the enormous morbidity and mortality caused by respiratory syncytial virus (RSV) infections among infants and the elderly, vaccines against RSV infections are in large market demand. Methods: We conducted a first-in-human (FIH), randomized, double-blind, placebo-controlled dose esca...

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Autores principales: Cheng, Xin, Zhao, Gan, Dong, Aihua, He, Zhonghuai, Wang, Jiarong, Jiang, Brian, Wang, Bo, Wang, Miaomiao, Huai, Xuefen, Zhang, Shijie, Feng, Shuangshuang, Qin, Hong, Wang, Bin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10221330/
https://www.ncbi.nlm.nih.gov/pubmed/37243103
http://dx.doi.org/10.3390/vaccines11050999
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author Cheng, Xin
Zhao, Gan
Dong, Aihua
He, Zhonghuai
Wang, Jiarong
Jiang, Brian
Wang, Bo
Wang, Miaomiao
Huai, Xuefen
Zhang, Shijie
Feng, Shuangshuang
Qin, Hong
Wang, Bin
author_facet Cheng, Xin
Zhao, Gan
Dong, Aihua
He, Zhonghuai
Wang, Jiarong
Jiang, Brian
Wang, Bo
Wang, Miaomiao
Huai, Xuefen
Zhang, Shijie
Feng, Shuangshuang
Qin, Hong
Wang, Bin
author_sort Cheng, Xin
collection PubMed
description Background: With the enormous morbidity and mortality caused by respiratory syncytial virus (RSV) infections among infants and the elderly, vaccines against RSV infections are in large market demand. Methods: We conducted a first-in-human (FIH), randomized, double-blind, placebo-controlled dose escalation study to evaluate the safety and immunogenicity response of the rRSV vaccine (BARS13) in healthy adults aged 18–45. A total of 60 eligible participants were randomly assigned to receive one of four dose levels or vaccination regimens of BARS13 or placebo at a 4:1 ratio. Results: The mean age was 27.40, and 23.3% (14/60) were men. No treatment-emergent adverse events (TEAEs) led to study withdrawal within 30 days after each vaccination. No serious adverse event (SAE) was reported. Most of the treatment-emergent adverse events (TEAEs) recorded were classified as mild. The high-dose repeat group had a serum-specific antibody GMC of 885.74 IU/mL (95% CI: 406.25–1931.17) 30 days after the first dose and 1482.12 IU/mL (706.56–3108.99) 30 days after the second dose, both higher than the GMC in the low-dose repeat group (885.74 IU/mL [406.25–1931.17] and 1187.10 IU/ mL [610.01–2310.13]). Conclusions: BARS13 had a generally good safety and tolerability profile, and no significant difference in terms of adverse reaction severity or frequency was observed between different dose groups. The immune response in repeat-dose recipients shows more potential in further study and has guiding significance for the dose selection of subsequent studies.
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spelling pubmed-102213302023-05-28 A First-in-Human Trial to Evaluate the Safety and Immunogenicity of a G Protein-Based Recombinant Respiratory Syncytial Virus Vaccine in Healthy Adults 18–45 Years of Age Cheng, Xin Zhao, Gan Dong, Aihua He, Zhonghuai Wang, Jiarong Jiang, Brian Wang, Bo Wang, Miaomiao Huai, Xuefen Zhang, Shijie Feng, Shuangshuang Qin, Hong Wang, Bin Vaccines (Basel) Article Background: With the enormous morbidity and mortality caused by respiratory syncytial virus (RSV) infections among infants and the elderly, vaccines against RSV infections are in large market demand. Methods: We conducted a first-in-human (FIH), randomized, double-blind, placebo-controlled dose escalation study to evaluate the safety and immunogenicity response of the rRSV vaccine (BARS13) in healthy adults aged 18–45. A total of 60 eligible participants were randomly assigned to receive one of four dose levels or vaccination regimens of BARS13 or placebo at a 4:1 ratio. Results: The mean age was 27.40, and 23.3% (14/60) were men. No treatment-emergent adverse events (TEAEs) led to study withdrawal within 30 days after each vaccination. No serious adverse event (SAE) was reported. Most of the treatment-emergent adverse events (TEAEs) recorded were classified as mild. The high-dose repeat group had a serum-specific antibody GMC of 885.74 IU/mL (95% CI: 406.25–1931.17) 30 days after the first dose and 1482.12 IU/mL (706.56–3108.99) 30 days after the second dose, both higher than the GMC in the low-dose repeat group (885.74 IU/mL [406.25–1931.17] and 1187.10 IU/ mL [610.01–2310.13]). Conclusions: BARS13 had a generally good safety and tolerability profile, and no significant difference in terms of adverse reaction severity or frequency was observed between different dose groups. The immune response in repeat-dose recipients shows more potential in further study and has guiding significance for the dose selection of subsequent studies. MDPI 2023-05-18 /pmc/articles/PMC10221330/ /pubmed/37243103 http://dx.doi.org/10.3390/vaccines11050999 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Cheng, Xin
Zhao, Gan
Dong, Aihua
He, Zhonghuai
Wang, Jiarong
Jiang, Brian
Wang, Bo
Wang, Miaomiao
Huai, Xuefen
Zhang, Shijie
Feng, Shuangshuang
Qin, Hong
Wang, Bin
A First-in-Human Trial to Evaluate the Safety and Immunogenicity of a G Protein-Based Recombinant Respiratory Syncytial Virus Vaccine in Healthy Adults 18–45 Years of Age
title A First-in-Human Trial to Evaluate the Safety and Immunogenicity of a G Protein-Based Recombinant Respiratory Syncytial Virus Vaccine in Healthy Adults 18–45 Years of Age
title_full A First-in-Human Trial to Evaluate the Safety and Immunogenicity of a G Protein-Based Recombinant Respiratory Syncytial Virus Vaccine in Healthy Adults 18–45 Years of Age
title_fullStr A First-in-Human Trial to Evaluate the Safety and Immunogenicity of a G Protein-Based Recombinant Respiratory Syncytial Virus Vaccine in Healthy Adults 18–45 Years of Age
title_full_unstemmed A First-in-Human Trial to Evaluate the Safety and Immunogenicity of a G Protein-Based Recombinant Respiratory Syncytial Virus Vaccine in Healthy Adults 18–45 Years of Age
title_short A First-in-Human Trial to Evaluate the Safety and Immunogenicity of a G Protein-Based Recombinant Respiratory Syncytial Virus Vaccine in Healthy Adults 18–45 Years of Age
title_sort first-in-human trial to evaluate the safety and immunogenicity of a g protein-based recombinant respiratory syncytial virus vaccine in healthy adults 18–45 years of age
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10221330/
https://www.ncbi.nlm.nih.gov/pubmed/37243103
http://dx.doi.org/10.3390/vaccines11050999
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