Vaccines having an antigen and interleukin-21 as an adjuvant
Inventors
Weiner, David B. • Morrow, Matthew P.
Assignees
University of Pennsylvania Penn • Inovio Pharmaceuticals Inc
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Publication Number
US-12280108-B2
Publication Date
2025-04-22
Expiration Date
Abstract
The invention includes a vaccine comprising an antigen and IL-21. The invention also includes methods for increasing an immune response in a subject. The methods may comprise administering the vaccine to the subject in need thereof.
Core Innovation
The invention provides an immunogenic composition that includes at least one selected from an antigen and a nucleic acid molecule encoding an antigen, wherein the antigen is selected from an human papilloma virus (HPV) antigen or fragment, a Human Immunodeficiency Virus (HIV) antigen or fragment, an influenza antigen or fragment, a Plasmodium falciparum antigen or fragment, and a C. difficile antigen or fragment. The composition further comprises a nucleic acid molecule comprising a nucleotide sequence encoding interleukin-21 (IL-21), and the IL-21 comprises an amino acid sequence selected from the sequence set forth in SEQ ID NO: 4 and an amino acid sequence that is at least about 90% identical to the entire length of the amino acid sequence set forth in SEQ ID NO: 4.
The immunogenic composition supports antigen presentation by combining antigen or antigen-encoding nucleic acid with IL-21-encoding nucleic acid, and optionally includes IL-21-encoding nucleic acids and antigen encoding nucleic acids and corresponding peptides in the described vaccine embodiments. The IL-21 nucleic acid is disclosed as IL-21-encoding nucleic acids, including nucleic acids associated with SEQ ID NO: 3 and identity criteria, and may be optionally included in an expression vector. Antigens are disclosed as including antigen sets directed to HPV, HIV, influenza, Plasmodium falciparum, and C. difficile, including toxin A and toxin B.
The invention addresses enhancing immune responses elicited by vaccination. In the disclosed embodiments, administering the DNA/peptide-containing vaccine together with IL-21 is described to increase cellular and/or humoral responses, including increased IFN-gamma production and antibody responses such as IgG and IgA. Example embodiments include intramuscular electroporated DNA vaccination that yields both cellular and humoral responses to HIV Env antigens and enhances humoral responses to C. difficile toxins.
Claims Coverage
The provided independent claims cover two distinct subject-matter categories: an immunogenic composition combining selected antigens with an IL-21-encoding nucleic acid, and a protein defined by IL-21 amino acid sequences. Across these independent claims, the core inventive elements include the antigen or antigen-encoding component, the IL-21 nucleic acid or IL-21 protein sequence identity requirements, and the specified SEQ ID NO: 4-based IL-21 sequence bounds.
Antigen plus IL-21-encoding nucleic acid immunogenic composition
An immunogenic composition comprising at least one selected from an antigen and a nucleic acid molecule encoding an antigen, wherein the antigen is selected from an HPV antigen or fragment, an HIV antigen or fragment, an influenza antigen or fragment, a Plasmodium falciparum antigen or fragment, and a C. difficile antigen or fragment; and a nucleic acid molecule comprising a nucleotide sequence encoding IL-21, wherein IL-21 comprises an amino acid sequence selected from an amino acid sequence as set forth in SEQ ID NO: 4 and an amino acid sequence that is at least about 90% identical to the entire length of the amino acid sequence as set forth in SEQ ID NO: 4.
IL-21 protein defined by SEQ ID NO: 4 sequence identity
A protein comprising one or more amino acid sequences selected from an amino acid sequence as set forth in SEQ ID NO: 4 and an amino acid sequence that is at least about 90% identical to the entire length of the amino acid sequence as set forth in SEQ ID NO: 4.
Overall, the independent claim coverage centers on IL-21 linked to vaccination constructs: either through an immunogenic composition containing selected pathogen antigens with an IL-21-encoding nucleic acid defined by SEQ ID NO: 4 or about 90% full-length identity, or through an IL-21 protein whose amino acid sequence meets the same SEQ ID NO: 4 identity bounds.
Stated Advantages
Increases cellular and/or humoral responses.
Increases IFN-gamma production.
Enhances humoral responses to C. difficile toxins.
Induces both cellular and humoral responses to HIV Env antigens after intramuscular electroporated DNA vaccination.
Documented Applications
Vaccination using a DNA/peptide-containing vaccine with IL-21, including intramuscular electroporated DNA vaccination, is described as increasing cellular and/or humoral responses.
Assessed immunogenicity includes humoral responses to C. difficile toxins and cellular and humoral responses to HIV Env antigens in the described examples.
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