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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...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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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. |
format | Online Article Text |
id | pubmed-10221330 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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