Vaccine composition for chickenpox or Varicella Zoster and method of using same
Inventors
Lee, Chan Kyu • Lovell, Jonathan F. • YUN, Jee Sun • Kim, Seok Kyu • LEE, Byung Man • HA, Da Hui • Lee, Jeong Yoon • LEE, Choon Geun • LEE, Ye Ram • Huang, Wei-Chiao • HAN, Jemin
Assignees
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Publication Number
US-12527859-B2
Publication Date
2026-01-20
Expiration Date
Abstract
Provided are a vaccine composition for Varicella Zoster virus (VZV) including a glycoprotein E (gE) antigen of VZV and monophosphoryl lipid A (MLA), and a method of using the same. The vaccine composition according to an aspect of the invention may significantly improve a production yield by including the gE antigen having an optimized signal peptide sequence, may enhance immunogenicity by including MLA, and may further enhance the immunogenicity enhanced by MLA by further adding saponin such as QS-21, and may be prepared in a form of CoPoP liposomes so that vaccine antigens may be presented on the surface of the liposomes for better absorption by antigen-presenting cells, and vaccine efficacy may be maximized by inclusion of the vaccine antigens and immune adjuvants in a formulation. Therefore, the vaccine composition may be useful as an alternative to current vaccines in the art for prevention or treatment of VZV infection.
Core Innovation
The invention relates to a vaccine composition comprising a glycoprotein E (gE) antigen of Varicella Zoster virus (VZV) having an amino acid sequence of SEQ ID NO: 1, together with monophosphoryl lipid A (MLA). The described gE antigen is presented as a truncated gE lacking the C-terminal anchor region and includes an optimized CHO signal peptide, with an optional polyhistidine tag.
The invention further enhances immunogenicity by presenting the gE on the surface of cobalt-porphyrin-phospholipid (CoPoP) liposomes. This includes a claimed coordinate bond between histidine and cobalt that exposes the antigen exterior, together with formulation with MLA and optionally saponin (QS-21).
The problem addressed is improved vaccine efficacy and performance relative to existing Zostavax formulations, including improved antigen production yield. The document reports enhanced immunogenicity supported by mouse immunogenicity comparisons, including large increases in antibody titers (ELISA) and IFN-gamma secretion for formulations containing MLA, and additional cellular enhancement with QS-21-containing formulations while incorporating the CoPoP presentation strategy.
Claims Coverage
The independent claim coverage centers on a vaccine composition with two core inventive components: a VZV gE antigen defined by SEQ ID NO: 1 and monophosphoryl lipid A (MLA). Dependent claims refine the inventive scope by specifying particular antigen sequence variants and MLA species, and by constraining the formulation to liposomes and adding CoPoP conjugates, optional saponin, and polyhistidine-tag constraints (including a 5 to 10 histidine residue range).
Varicella Zoster virus gE antigen with SEQ ID NO: 1 plus monophosphoryl lipid A (MLA)
A vaccine composition comprising a glycoprotein E (gE) antigen of Varicella Zoster virus (VZV) having an amino acid sequence of SEQ ID NO: 1, and monophosphoryl lipid A (MLA).
MLA limited to specific dephosphorylated lipid A species
The vaccine composition where MLA comprises one or more dephosphorylated lipid A species including 1-dephosphorylated-lipid A, 1-dephosphorylated-pentaacyl lipid A, and/or 1-dephosphorylated-tetraacyl lipid A.
Liposome formulation vaccine composition
The vaccine composition is a liposome formulation.
Cobalt-porphyrin-phospholipid (CoPoP) conjugate with optional saponin
The vaccine composition includes a cobalt-porphyrin-phospholipid (CoPoP) conjugate made from a phospholipid and a cobalt-porphyrin with cobalt-coordinated porphyrins, or includes a CoPoP conjugate together with saponin.
gE polyhistidine tagging
The vaccine composition in which the gE antigen is tagged with polyhistidine.
Polyhistidine length range 5 to 10 histidine residues
The vaccine composition includes a polyhistidine component made up of 5 to 10 histidine residues.
Across the claim set, the inventive coverage is anchored in a VZV gE antigen defined by SEQ ID NO: 1 combined with MLA, then narrowed by specifying dephosphorylated lipid A species and by optionally shifting to a liposome formulation that includes a CoPoP conjugate, optional saponin, and polyhistidine-tagged gE with a defined polyhistidine length range.
Stated Advantages
Improved antigen production yield via signal peptide optimization.
Improved vaccine efficacy versus Zostavax.
Enhanced immunogenicity evidenced by increased antibody titers (ELISA) for MLA- and CoPoP-containing formulations.
Enhanced cellular immune response shown by increased IFN-gamma secretion.
Additional cellular enhancement with QS-21-containing formulations.
Documented Applications
Vaccine compositions intended for chickenpox and herpes zoster using VZV gE antigen formulated with MLA and optionally CoPoP liposomes and/or QS-21.
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