Vaccines for HSV-2
Inventors
Dubensky, Jr., Thomas W. • Hosken, Nancy A. • Robbins, Scott H. • MOORE, MARGARET D.
Assignees
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Publication Number
US-9895435-B2
Publication Date
2018-02-20
Expiration Date
Abstract
Compositions of recombinant HSV-2 proteins and an agonist of the innate immune system, such as an adjuvant, are provided as a vaccine. Proteins include an envelope glycoprotein and a structural protein other than an envelope glycoprotein, e.g., a capsid or tegument protein. The vaccine is for use in either HSV-2 seropositive or seronegative subjects.
Core Innovation
The invention provides a method for treating an HSV-2 infection by administering to a subject an immunogenic pharmaceutical composition. The composition includes an immunogenic fragment of HSV-2 UL19 comprising the amino acid sequence set forth in SEQ ID NO:12, with defined deletion constraints relative to SEQ ID NO:4 and defined identity constraints for immunogenic variants, together with glycoprotein D of HSV-2 (gD2) comprising the amino acid sequence set forth in SEQ ID NO:2 or 3, or an immunogenic fragment comprising at least 15 contiguous amino acids of SEQ ID NO:2 or 3.
The composition further includes UL25 comprising the amino acid sequence set forth in SEQ ID NO:5, or an immunogenic fragment comprising at least 15 contiguous amino acids of SEQ ID NO:5, and Glucopyranosyl Lipid Adjuvant (GLA). The disclosure describes prophylactic and therapeutic use in HSV-2 seropositive or seronegative subjects.
The invention also provides a method for generating an immune response to HSV-2 by administering the same defined set of HSV-2 immunogenic components, including the UL19 immunogenic fragment, gD2, and UL25, together with GLA. The disclosure additionally describes that GLA may be formulated as an oil-in-water emulsion or as an aqueous form, and that optional additional adjuvants may be selected from specified categories.
Claims Coverage
Two independent methods are covered. Both are grounded on administering an immunogenic pharmaceutical composition containing defined HSV-2 polypeptide components and Glucopyranosyl Lipid Adjuvant (GLA), with dependent claims further refining sequence constraints and optional adjuvant/formulation selections.
Treating HSV-2 with a defined UL19 fragment, gD2, UL25, and GLA
Administer to a subject an immunogenic pharmaceutical composition comprising an immunogenic fragment of HSV-2 UL19 comprising the amino acid sequence set forth in SEQ ID NO:12 with defined deletion and identity constraints, gD2 comprising the amino acid sequence set forth in SEQ ID NO:2 or 3 (or an immunogenic fragment comprising at least 15 contiguous amino acids), UL25 comprising the amino acid sequence set forth in SEQ ID NO:5 (or an immunogenic fragment comprising at least 15 contiguous amino acids), and Glucopyranosyl Lipid Adjuvant (GLA).
Generating an HSV-2 immune response with a defined UL19 fragment, gD2, UL25, and GLA
Administer to a subject an immunogenic pharmaceutical composition comprising an immunogenic fragment of HSV-2 UL19 comprising the amino acid sequence set forth in SEQ ID NO:12 with defined deletion and identity constraints, gD2 comprising the amino acid sequence set forth in SEQ ID NO:2 or 3 (or an immunogenic fragment comprising at least 15 contiguous amino acids), UL25 comprising the amino acid sequence set forth in SEQ ID NO:5 (or an immunogenic fragment comprising at least 15 contiguous amino acids), and Glucopyranosyl Lipid Adjuvant (GLA).
Across both independent claims, the core coverage is directed to administering an immunogenic pharmaceutical composition defined by an UL19 immunogenic fragment with sequence and deletion constraints, gD2 comprising SEQ ID NO:2 or 3 (or at least 15 contiguous amino acids thereof), UL25 comprising SEQ ID NO:5 (or at least 15 contiguous amino acids thereof), and GLA.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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