Influenza vaccine composition based on novel nucleic acid

Inventors

KIM, Mee Hyein • Shin, Jin Soo • Kim, Dong Ho • Kim, Eui Ho • Kang, Myung Soo • JANG, Ye Jin

Assignees

Na Vaccine Institute

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Publication Number

US-12514919-B2

Patent

Publication Date

2026-01-06

Expiration Date


Abstract

Provided is an influenza vaccine composition based on a novel ribonucleic acid having a dual function of serving as an immunity-boosting agent and capturing antigens.

Core Innovation

The invention relates to a vaccine composition for preventing or treating influenza virus infection that comprises a hetero-structured ribonucleic acid (hsRNA) and a human influenza virus antigen. The hsRNA comprises a double-stranded ribonucleic acid (dsRNA) and single-stranded ribonucleic acids (ssRNAs), where the dsRNA is formed by complementary binding between a first single-stranded RNA and a second single-stranded RNA, and the ssRNAs are linked at both 3′-ends of the dsRNA. The influenza virus is influenza virus A or B type.

The hsRNA length is defined as 140 nt to 1682 nt, with the dsRNA region having 106 nt to 1648 nt and the ssRNA region having 1 to 10 nt. The hsRNA is obtained by complementary binding between the nucleotide sequences of SEQ ID NO: 1 and SEQ ID NO: 2, or has a UAUAG sequence at both 3′-ends of dsRNA. The UAUAG sequence arrangement is obtained by complementary binding between the nucleotide sequence of SEQ ID NO: 3 and a complementary sequence thereof.

The disclosure further describes loading influenza antigen into the hsRNA-based formulation, including inactivated influenza whole virus or surface/subunit antigens. The disclosed immune mechanism is centered on TLR3 activation and enhanced antigen presentation through capture/delivery to antigen-presenting cells, particularly following intranasal administration to induce mucosal immunity. The document describes cross-protective immunity against homotypic and heterosubtypic influenza A/B challenges and reports increased mucosal IgA and lung CD4+ IFNγ+ T cells with cross-protection dependent on CD4 T cells.

Claims Coverage

The provided claim set presents one explicit independent claim for a vaccine composition, with additional features refining the hsRNA structure, influenza antigen formats and subtypes, and an immunization method.

Hetero-structured ribonucleic acid vaccine composition for influenza A/B

A vaccine composition for preventing or treating influenza virus infection comprising a hetero-structured ribonucleic acid (hsRNA) having dsRNA and ssRNAs, and a human influenza virus antigen, wherein the dsRNA is formed by complementary binding between a first single-stranded RNA and a second single-stranded RNA, and the ssRNAs are linked at both 3′-ends of the dsRNA, with hsRNA length 140 nt to 1682 nt and dsRNA region length 106 nt to 1648 nt.

hsRNA obtained by complementary binding with defined 3′-end sequence

The hsRNA is obtained by complementary binding between the nucleotide sequence of SEQ ID NO: 1 and the nucleotide sequence of SEQ ID NO: 2, or has a UAUAG sequence at both the 3′-ends of dsRNA obtained by complementary binding between the nucleotide sequence of SEQ ID NO: 3 and a complementary sequence thereof.

Influenza A or B antigen with optional antigen format refinement

The vaccine composition wherein the influenza virus is influenza virus A or B type, and the human influenza virus antigen is specified as inactivated or live attenuated influenza whole virus, a subvirion, or a subunit.

Immunizing method by administering the composition to a subject

A method of immunizing a subject against an influenza virus comprising administering the vaccine composition, wherein the influenza virus is influenza virus type A or B.

The claims center on a vaccine composition that combines a dsRNA/ssRNA-linked hsRNA with a human influenza virus antigen for influenza A/B, including defined complementary-binding structures and defined 3′-end sequence features, together with antigen format refinements and a method claim based on administering the composition to a subject.

Stated Advantages

Cross-protective immunity against homotypic and heterosubtypic influenza A/B challenges.

Increased mucosal IgA and lung CD4+ IFNγ+ T cells.

Cross-protection dependent on CD4 T cells.

Enhanced antigen presentation through capture/delivery to antigen-presenting cells.

Induction of mucosal immunity following intranasal administration.

TLR3 activation.

Documented Applications

Preventing or treating influenza virus infection.

Immunizing a subject against influenza virus type A or B.

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