Comprehensive Analysis of the Safety Profile of a Single-Stranded RNA Nano-Structure Adjuvant
2019
Adjuvantsenhance the efficacy of vaccines by stimulating immune response-related gene expression and pathways. Although some
adjuvantshave 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
adjuvantin vitro and in vivo. Mice were intramuscularly immunized with the ssRNA nano-structure
adjuvantthree 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
adjuvantto increase
vaccine efficacies.
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