WO2012074881A2 - Vaccines against herpes simplex virus type 2: compositions and methods for eliciting an immune response - Google Patents

Vaccines against herpes simplex virus type 2: compositions and methods for eliciting an immune response Download PDF

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Publication number
WO2012074881A2
WO2012074881A2 PCT/US2011/062120 US2011062120W WO2012074881A2 WO 2012074881 A2 WO2012074881 A2 WO 2012074881A2 US 2011062120 W US2011062120 W US 2011062120W WO 2012074881 A2 WO2012074881 A2 WO 2012074881A2
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seq
vaccine formulation
hsv
polypeptide
vaccine
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Ceased
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PCT/US2011/062120
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English (en)
French (fr)
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WO2012074881A3 (en
Inventor
Deborah Long
Jessica Flechtner
Mojca Skoberne
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Genocea Biosciences Inc
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Genocea Biosciences Inc
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Priority to AU2011336894A priority Critical patent/AU2011336894B2/en
Priority to EP11844992.5A priority patent/EP2643014A4/en
Priority to JP2013541060A priority patent/JP6055776B2/ja
Priority to US13/989,119 priority patent/US9782474B2/en
Priority to CA 2856697 priority patent/CA2856697A1/en
Publication of WO2012074881A2 publication Critical patent/WO2012074881A2/en
Publication of WO2012074881A3 publication Critical patent/WO2012074881A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/245—Herpetoviridae, e.g. herpes simplex virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/205—Rhabdoviridae, e.g. rabies virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • A61P31/22—Antivirals for DNA viruses for herpes viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A61K2039/5252—Virus inactivated (killed)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/53—DNA (RNA) vaccination
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505—Inorganic adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55522—Cytokines; Lymphokines; Interferons
    • A61K2039/55527—Interleukins
    • A61K2039/55538—IL-12
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55577—Saponins; Quil A; QS21; ISCOMS
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55583—Polysaccharides
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/16011—Herpesviridae
    • C12N2710/16034—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/16011—Herpesviridae
    • C12N2710/16611—Simplexvirus, e.g. human herpesvirus 1, 2
    • C12N2710/16634—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

Definitions

  • HSV-2 is most often transmitted by sexual contact, and infection with the virus typically leads to recurring outbreaks of lesions on the genitals and perianal regions, combined with shedding of virus into the genital tract. Viral shedding can also occur in the absence of lesions or other symptoms.
  • HSV-2 also establishes latency in sensory ganglia. HSV-2 infection causes physical discomfort and psychosexual morbidity in affected patients, and introduces additional health risks. In particular, patients infected with HSV-2 are at increased risk for contracting HIV, and pregnant mothers infected with HSV-2 can vertically transmit HSV-2 to their fetuses. In immunocompromised individuals or in neonates, HSV-2 infections can be fatal. Currently, there is no cure for HSV-2 infection.
  • the present disclosure describes a vaccine formulation comprising a pharmaceutically-acceptable carrier and at least one polypeptide consisting of SEQ ID NO: 136 or an immunogenic fragment thereof
  • the vaccine formulation may comprise a first polypeptide consisting of the above SEQ ID NO, a second polypeptide consisting of SEQ ID NO: 1 or SEQ ID NO: 4 and optionally a third polypeptide consisting of the other of SEQ ID NOS: 1 and 4.
  • the second or third polypeptide consists of polypeptide fragments of SEQ ID NO: 1, such as the polypeptides of SEQ ID NOS: 2, 8-16, 138 and 139, or immunogenic fragments thereof.
  • the vaccine formulation may comprise a first polypeptide consisting of SEQ ID NO: 136, a second polypeptide consisting of SEQ ID NO: 4 or SEQ ID NO: 5, a third polypeptide selected from the group consisting of SEQ ID NOS: 2, 8-16, 138 and 139, and optionally a fourth polypeptide selected from the group consisting of SEQ ID NOS: 2, 8-16, 138 and 139, or immunogenic fragments thereof.
  • Yet another aspect of the present invention provides a method of reducing one or more symptoms of HSV-2 infection in a subject, comprising administering to said subject an effective amount of a vaccine formulation or a pharmaceutical composition as described herein.
  • the symptoms of HSV-2 infection comprise one or more of lesion formation, pain, irritation, itching, fever, malaise, headache, viral shedding, and prodrome.
  • an aspect of the present invention provides a method of reducing recurrence of outbreaks in a subject infected with HSV-2, comprising administering an effective amount of a vaccine formulation or a composition as described herein.
  • An additional aspect of the present invention provides a method of producing any of the pharmaceutical compositions described above, comprising expressing said two or more polypeptides; and isolating said two or more polypeptides.
  • Figures 2A and B depict exemplary graphs illustrating, respectively, CD4 + and
  • FIGS. 4A and B depict exemplary graphs illustrating the number of IFN- ⁇ spot forming units per 2xl0 5 CD4 + 3 ⁇ 4 > anel A) or CD8 + (Panel B) T cells, following immunization with gD2ATMR, ICP4.2, gD2ATMR plus ICP4, gL2s v.2, UL40 protein, and gL2s v.2 plus UL40 protein.
  • Figures 8A and B depict exemplary graphs illustrating the average number of
  • Table 2 may be used in pharmaceutical compositions.
  • the invention provides pharmaceutical compositions containing immunogenic polypeptides or polynucleotides encoding these immunogenic polypeptides together with a pharmaceutical carrier.
  • Antigens from HSV-2 may be identified by screening immune cells from patients exposed to or infected with HSV-2. Briefly, a library of HSV-2 antigens was expressed by bacteria and mixed with APCs. The APCs, in turn, processed and presented HSV-2-derived peptides to lymphocytes that had been isolated from human patients exposed to or infected with HSV-2.
  • the patients belonged to several populations: (1) exposed to HSV-2 but seronegative for infection, (2) infected with HSV-2 but asymptomatic, (3) infected with HSV-2 and experiencing infrequent outbreaks, (4) infected with HSV-2 and experiencing frequent outbreaks, (5) na ' ive and (6) seronegative for HSV-2 (HSV-2-) but seropositive for HSV-1 (HSV-1+ ). Lymphocyte responses from each population were compared for reactivity to HSV-2-derived polypeptides, and the screen detected antigens that induced reactive lymphocytes with greater frequency in one patient population as compared to the others.
  • molecule covalently bound
  • This may, for example, increase the half-life, solubility, bioavailability, or immunogenicity of the antigen.
  • Molecules that may be conjugated to an immunogenic polypeptide include a carbohydrate, biotin, poly(ethylene glycol) (PEG), polysialic acid, N-propionylated polysialic acid, nucleic acids, polysaccharides, and PLGA.
  • PEG poly(ethylene glycol)
  • PEG polysialic acid
  • N-propionylated polysialic acid nucleic acids
  • polysaccharides and PLGA.
  • PEG chains can be linear, branched, or with comb or star geometries.
  • ICP4 (SEQ ID NO: 1) encoded by RSI
  • NLGFLMHAP (SEQ ID NO: 83)
  • fragments described above or sub-fragments thereof preferably have one of the biological activities described below, such as increasing the T cell response by at least 1.5 fold or 2 fold.
  • a fragment may be used as the polypeptide in the vaccines described herein or may be fused to another protein, protein fragment or a polypeptide.
  • this application provides immunogenic polypeptides with at least 90%, 95%, 97%, 98%, 99%, or 99.5% identity to gD2ATMR, or an immunogenic fragment thereof.
  • fragments described above or sub-fragments thereof preferably have one of the biological activities described below, such as increasing the T cell response by at least 1.5 fold or 2 fold.
  • a fragment may be used as the polypeptide in the vaccines described herein or may be fused to another protein, protein fragment or a polypeptide.
  • the fragments are close in size to the full-length polypeptide. For example, they may lack at most one, two, three, four, five, ten, or twenty amino acids from one or both termini.
  • the fragment is 50-1 130 amino acids in length, or 100-1 130, 150-1 130, or 200-1 130, or 250-1 130, or 300-1 130, or 400-1 130, or 500-1 130, or 600-1 130, or 700-1 130, or 800-1 130, or 900-1 130, or 1000-1 130 amino acids in length.
  • adjuvants may be classified as organic and inorganic.
  • Inorganic adjuvants include aluminum salts such as aluminum phosphate, amorphous aluminum
  • Such adjuvants may comprise fraction A and fraction C mixed into a ratio of 70-95 A: 30-5 C, such as 70 A : 30 C to 75 A : 25 C; 75 A : 25 C to 80 A : 20 C; 80 A : 20 C to 85 A : 15 C; 85 A : 15 C to 90 A : 10 C; 90 A : 10 C to 95 A : 5 C; or 95 A : 5 C to 99 A : 1 C.
  • Adjuvants may be directly conjugated to antigens. Adjuvants may also be combined to increase the magnitude of the immune response to the antigen. Typically, the same adjuvant or mixture of adjuvants is present in each dose of a vaccine. Optionally, however, an adjuvant may be administered with the first dose of vaccine and not with subsequent doses (i.e. booster shots). Alternatively, a strong adjuvant may be administered with the first dose of vaccine and a weaker adjuvant or lower dose of the strong adjuvant may be administered with subsequent doses. The adjuvant can be administered before the administration of the antigen, concurrent with the administration of the antigen or after the administration of the antigen to a subject (sometimes within 1, 2, 6, or 12 hours, and sometimes within 1, 2, or 5 days). Certain adjuvants are appropriate for human patients, non-human animals, or both.
  • DNA vaccines including the DNA encoding the desired antigen, can be introduced into a host cell in any suitable form including, the fragment alone, a linearized plasmid, a circular plasmid, a plasmid capable of replication, an episome, RNA, etc.
  • the gene is contained in a plasmid.
  • the plasmid is an expression vector.
  • Individual expression vectors capable of expressing the genetic material can be produced using standard recombinant techniques. See e.g., Maniatis et al., 1985 Molecular Cloning: A
  • the DNA vaccine may further comprises a
  • the HSV-2 vaccine is administered to an individual post-infection.
  • the HSV-2 vaccine may be administered shortly after infection, e.g. before symptoms manifest, or may be administered during or after manifestation of symptoms.
  • the HSV-2 vaccine may prevent endogenous reactivation of earlier infection.
  • a post-infection vaccine could be administered to patients in high-risk groups.
  • Delivery by electroporation may be intramuscular or intradermal.
  • Suitable devices for electroporation include devices made by Inovio Pharmaceuticals, Inc. (Blue Bell, PA) and the TriGridTM Delivery System made by Ichor Medical Systems, Inc. (San Diego, CA).
  • the vaccine comprising a polypeptide contains less than
  • the antigens alone or in combination with other suitable components, can be made into aerosol formulations (e.g. , they can be "nebulized") to be administered via inhalation. Aerosol formulations can be placed into pressurized acceptable propellants, such as
  • Table 3 shows the frequency analysis for thirteen HSV-2 antigens encoded by ULIO, UL19, UL40, US4, US6, RS I (RS1.1 , RS 1.2, RS 1.3), UL36 (UL36.3, UL 36.4, UL36.5), UL32, and RL2 in the exposed patient cohort compared to the recurrer cohorts (frequent and less-frequent recurrers combined).
  • Figures 8A and B depict exemplary graphs illustrating the average number of
  • SEQ ID NO: 17 predicted sequence for uracil DNA glycosylase encoded by UL2
  • SEQ ID NO: 24 ICPl/2 internal fragment encoded by construct UL36.4.2.5
  • SEQ ID NO: 128 construct RSI .7

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PCT/US2011/062120 2010-11-24 2011-11-23 Vaccines against herpes simplex virus type 2: compositions and methods for eliciting an immune response Ceased WO2012074881A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
AU2011336894A AU2011336894B2 (en) 2010-11-24 2011-11-23 Vaccines against Herpes Simplex Virus type 2: compositions and methods for eliciting an immune response
EP11844992.5A EP2643014A4 (en) 2010-11-24 2011-11-23 HERPES SIMPLEX TYPE 2 VIRUS VACCINES: COMPOSITIONS AND METHODS FOR STIMULATING AN IMMUNE RESPONSE
JP2013541060A JP6055776B2 (ja) 2010-11-24 2011-11-23 単純ヘルペスウイルス２型に対するワクチン：免疫応答を誘発する組成物及び方法
US13/989,119 US9782474B2 (en) 2010-11-24 2011-11-23 Vaccines against herpes simplex virus type 2: compositions and methods for eliciting an immune response
CA 2856697 CA2856697A1 (en) 2010-11-24 2011-11-23 Vaccines against herpes simplex virus type 2: compositions and methods for eliciting an immune response

Applications Claiming Priority (2)

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US41708910P 2010-11-24 2010-11-24
US61/417,089 2010-11-24

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WO2012074881A2 true WO2012074881A2 (en) 2012-06-07
WO2012074881A3 WO2012074881A3 (en) 2012-09-13

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EP (1) EP2643014A4 (enExample)
JP (1) JP6055776B2 (enExample)
AU (1) AU2011336894B2 (enExample)
CA (1) CA2856697A1 (enExample)
WO (1) WO2012074881A2 (enExample)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017134061A1 (en) * 2016-02-01 2017-08-10 Gu Ventures Ab Truncated glycoprotein g of herpes simplex virus 2
CN107430708A (zh) * 2015-03-30 2017-12-01 X开发有限责任公司 对机器人系统组件使用进行的基于云的分析
US10350288B2 (en) 2016-09-28 2019-07-16 Genocea Biosciences, Inc. Methods and compositions for treating herpes
US10653771B2 (en) 2009-05-22 2020-05-19 Genocea Biosciences, Inc. Vaccines against herpes simplex virus type 2: compositions and methods for eliciting an immune response
EP3999093A4 (en) * 2019-07-19 2023-11-22 Merck Sharp & Dohme LLC ANTIGENIC E GLYCOPROTEIN POLYPEPTIDES, COMPOSITIONS AND METHODS OF USE THEREOF

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Publication number Priority date Publication date Assignee Title
WO2012074881A2 (en) * 2010-11-24 2012-06-07 Genocea Biosciences, Inc. Vaccines against herpes simplex virus type 2: compositions and methods for eliciting an immune response
JP6199878B2 (ja) * 2011-11-23 2017-09-20 ジェノセア バイオサイエンシーズ， インコーポレイテッド 単純ヘルペスウイルス２型に対する核酸ワクチン：免疫応答を誘発する組成物及び方法

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