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RNA-based adjuvants and their immunoenhancing effect on antiviral vaccines

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During the last decade, a wide variety of cellular RNA sensors and structural characteristics of their agonists have been identified. On the basis of this knowledge, RNA formulations were developed as innovative adjuvant candidates. In contrast to DNA, RNA does not have genotoxic potential and is rapidly degraded. In many aspects, RNA mimics viral infections and induces considerably strong immune responses. Additionally, RNA-based adjuvants can be designed so that distinct RNA sensors can be triggered according to requirements of individual vaccines. Furthermore, RNA can be synthesized in vitro in a cell-free system, and recent developments in formulation technology have led to reduced RNA degradation within the body. These features qualify RNA as a promising adjuvant candidate. Here, we discuss latest developments in the field of RNA-based adjuvants and highlight differences between human and mouse nucleic acid sensors, which constitute a challenge in the development of RNA-based adjuvants. Finally, we discuss how RNA-based adjuvants are currently handled with regard to regulatory requirements.

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Therapeutic vaccines are intended for the treatment of established diseases by harnessing the patient’s own immune system. In this article we discuss therapeutic areas that are of relevance for therapeutic vaccination, i.e., oncology and neurodegenerative diseases. Clinical and regulatory aspects related to the manufacture and clinical use of actively personalized cancer vaccines are thoroughly reviewed. This applies to the regulatory classification of genomic sequencing approaches to identify tumor-specific mutations, combination therapies with checkpoint inhibitors, clinical study designs, and the use of suitable adjuvants and drug substances. Huge amounts of data (big data) are increasingly being generated in the area of personalized therapies; we briefly address the impact and usability of big data in regulatory procedures.
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