Comprehensive Analysis of the Safety Profile of a Single-Stranded RNA Nano-Structure Adjuvant
Adjuvants enhance the efficacy of vaccines by stimulating immune response-related gene expression and pathways. Although some adjuvants have been approved for commercial use in human vaccines (e.g., Alum, MF59, and AS03), they might elicit adverse side effects, such as autoimmune diseases. Recently,...
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MDPI AG
2019-09-01
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Series: | Pharmaceutics |
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Online Access: | https://www.mdpi.com/1999-4923/11/9/464 |
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author | Hyeong-Jun Park Hae Li Ko Dong-Hoon Won Da-Bin Hwang Yoo-Sub Shin Hye-Won Kwak Hye-Jung Kim Jun-Won Yun Jae-Hwan Nam |
author_facet | Hyeong-Jun Park Hae Li Ko Dong-Hoon Won Da-Bin Hwang Yoo-Sub Shin Hye-Won Kwak Hye-Jung Kim Jun-Won Yun Jae-Hwan Nam |
author_sort | Hyeong-Jun Park |
collection | DOAJ |
description | Adjuvants enhance the efficacy of vaccines by stimulating immune response-related gene expression and pathways. Although some adjuvants have been approved for commercial use in human vaccines (e.g., Alum, MF59, and AS03), they might elicit adverse side effects, such as autoimmune diseases. Recently, we developed a novel single-stranded RNA (ssRNA) nano-structure adjuvant, which can stimulate both Th1 and Th2 responses. In this study, we evaluated the safety and toxicological profiles of this ssRNA nano-structure adjuvant in vitro and in vivo. Mice were intramuscularly immunized with the ssRNA nano-structure adjuvant three times, once every 2 weeks. The results indicate no significant differences in hematological and serum biochemistry parameters between the ssRNA-treated groups and the control group. From a histopathological perspective, no evidence of tissue damage was found in any group. The levels of IgE and anti-nuclear antibodies, which are markers of autoimmune disease, were not different between the ssRNA-treated groups and the control group. The findings of this study suggest that the ssRNA nano-structure can be used as a safe adjuvant to increase vaccine efficacies. |
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format | Article |
id | doaj.art-0eb39eafac0344db8d619ff20e13e57b |
institution | Directory Open Access Journal |
issn | 1999-4923 |
language | English |
last_indexed | 2024-12-10T06:45:57Z |
publishDate | 2019-09-01 |
publisher | MDPI AG |
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series | Pharmaceutics |
spelling | doaj.art-0eb39eafac0344db8d619ff20e13e57b2022-12-22T01:58:39ZengMDPI AGPharmaceutics1999-49232019-09-0111946410.3390/pharmaceutics11090464pharmaceutics11090464Comprehensive Analysis of the Safety Profile of a Single-Stranded RNA Nano-Structure AdjuvantHyeong-Jun Park0Hae Li Ko1Dong-Hoon Won2Da-Bin Hwang3Yoo-Sub Shin4Hye-Won Kwak5Hye-Jung Kim6Jun-Won Yun7Jae-Hwan Nam8Department of Biotechnology, The Catholic University of Korea, Bucheon 14662, KoreaDepartment of Biotechnology, The Catholic University of Korea, Bucheon 14662, KoreaDepartment of Biotechnology, The Catholic University of Korea, Bucheon 14662, KoreaDepartment of Biotechnology, The Catholic University of Korea, Bucheon 14662, KoreaDepartment of Biotechnology, The Catholic University of Korea, Bucheon 14662, KoreaDepartment of Biotechnology, The Catholic University of Korea, Bucheon 14662, KoreaDepartment of Biotechnology, The Catholic University of Korea, Bucheon 14662, KoreaDepartment of Biotechnology, The Catholic University of Korea, Bucheon 14662, KoreaDepartment of Biotechnology, The Catholic University of Korea, Bucheon 14662, KoreaAdjuvants enhance the efficacy of vaccines by stimulating immune response-related gene expression and pathways. Although some adjuvants have been approved for commercial use in human vaccines (e.g., Alum, MF59, and AS03), they might elicit adverse side effects, such as autoimmune diseases. Recently, we developed a novel single-stranded RNA (ssRNA) nano-structure adjuvant, which can stimulate both Th1 and Th2 responses. In this study, we evaluated the safety and toxicological profiles of this ssRNA nano-structure adjuvant in vitro and in vivo. Mice were intramuscularly immunized with the ssRNA nano-structure adjuvant three times, once every 2 weeks. The results indicate no significant differences in hematological and serum biochemistry parameters between the ssRNA-treated groups and the control group. From a histopathological perspective, no evidence of tissue damage was found in any group. The levels of IgE and anti-nuclear antibodies, which are markers of autoimmune disease, were not different between the ssRNA-treated groups and the control group. The findings of this study suggest that the ssRNA nano-structure can be used as a safe adjuvant to increase vaccine efficacies.https://www.mdpi.com/1999-4923/11/9/464nano-structure adjuvantvaccinessRNAautoimmune disease |
spellingShingle | Hyeong-Jun Park Hae Li Ko Dong-Hoon Won Da-Bin Hwang Yoo-Sub Shin Hye-Won Kwak Hye-Jung Kim Jun-Won Yun Jae-Hwan Nam Comprehensive Analysis of the Safety Profile of a Single-Stranded RNA Nano-Structure Adjuvant Pharmaceutics nano-structure adjuvant vaccine ssRNA autoimmune disease |
title | Comprehensive Analysis of the Safety Profile of a Single-Stranded RNA Nano-Structure Adjuvant |
title_full | Comprehensive Analysis of the Safety Profile of a Single-Stranded RNA Nano-Structure Adjuvant |
title_fullStr | Comprehensive Analysis of the Safety Profile of a Single-Stranded RNA Nano-Structure Adjuvant |
title_full_unstemmed | Comprehensive Analysis of the Safety Profile of a Single-Stranded RNA Nano-Structure Adjuvant |
title_short | Comprehensive Analysis of the Safety Profile of a Single-Stranded RNA Nano-Structure Adjuvant |
title_sort | comprehensive analysis of the safety profile of a single stranded rna nano structure adjuvant |
topic | nano-structure adjuvant vaccine ssRNA autoimmune disease |
url | https://www.mdpi.com/1999-4923/11/9/464 |
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