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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Main Authors: 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
Format: Article
Language:English
Published: MDPI AG 2019-09-01
Series:Pharmaceutics
Subjects:
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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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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