LIVE-ATTENUATED RNA HYBRID VACCINE TECHNOLOGY

    公开(公告)号:US20230338501A1

    公开(公告)日:2023-10-26

    申请号:US18024703

    申请日:2021-07-04

    CPC classification number: A61K39/12 C12N7/00 A61P31/14 A61K9/1075 A61K2039/53

    Abstract: This disclosure provides ribonucleic acid (RNA) polynucleotides encoding replication-competent viral genomes that, when introduced to a subject, induce an active viral replication. The RNA may be provided naked or with an artificial RNA delivery system. The viral genome may be a full-length genome of an attenuated viral strain. For example, the RNA may encode an attenuated Chikungunya or yellow fever virus. The artificial RNA delivery system may be a lipid particle such as a lipid nanoparticle (LNP), a nanostructure lipid carrier (NLC), or a cationic nanoemulsion (CNE). This disclosure also provides methods of inducing an immune response, including protective immunity, by administering to a subject an RNA polynucleotide that encodes a replication-competent viral genome in an amount sufficient to cause viral replication in the subject. The immune response may include inducing the production of neutralizing antibodies at a level comparable to inoculation with a live-attenuated virus.

    CO-LYOPHILIZED RNA AND NANOSTRUCTURED LIPID CARRIER

    公开(公告)号:US20230310323A1

    公开(公告)日:2023-10-05

    申请号:US18024733

    申请日:2021-07-02

    CPC classification number: A61K9/19 A61K9/1075 A61K39/12 A61K2039/55555

    Abstract: This disclosure provides thermostable, lyophilized compositions of nano structured lipid carrier (NLC) particles, methods of making the compositions, and methods of using the compositions for stimulating an immune response. The lyophilized compositions are in the form of cakes that form oil-in-water emulsions upon reconstitution. The compositions comprise NLC particles lyophilized in the presence of a cake-forming excipient. The compositions may be lyophilized with a bioactive agent, or the bioactive agent may be added after reconstitution. The bioactive agent may be RNA that encodes an antigen such as a viral protein. The thermostable, lyophilized compositions have uses as vaccine platforms or vaccines. The lyophilized cake maintains shape, structure, and color for at least 21 months stored at room temperature. Integrity and activity of the bioactive agent is maintained for at least eight months at room temperature and at least 21 months refrigerated.

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