CA2437899A1 - Vaccine for transcutaneous immunization against etec-caused traveler's diarrhea - Google Patents

Vaccine for transcutaneous immunization against etec-caused traveler's diarrhea Download PDF

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Publication number
CA2437899A1
CA2437899A1 CA002437899A CA2437899A CA2437899A1 CA 2437899 A1 CA2437899 A1 CA 2437899A1 CA 002437899 A CA002437899 A CA 002437899A CA 2437899 A CA2437899 A CA 2437899A CA 2437899 A1 CA2437899 A1 CA 2437899A1
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CA
Canada
Prior art keywords
immunogen
vaccine
cfa
immune response
sta
Prior art date
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Granted
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CA002437899A
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French (fr)
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CA2437899C (en
Inventor
Gregory M. Glenn
Frederick J. Cassels
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US Department of Army
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Individual
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Application filed by Individual filed Critical Individual
Publication of CA2437899A1 publication Critical patent/CA2437899A1/en
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Publication of CA2437899C publication Critical patent/CA2437899C/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K39/002—Protozoa antigens
    • A61K39/015—Hemosporidia antigens, e.g. Plasmodium 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
    • A61K39/02—Bacterial antigens
    • A61K39/025—Enterobacteriales, e.g. Enterobacter
    • A61K39/0258—Escherichia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
    • A61K9/7061—Polyacrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals
    • 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
    • A61P31/04—Antibacterial agents
    • 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
    • A61K2039/52—Bacterial cells; Fungal cells; Protozoal cells
    • A61K2039/521—Bacterial cells; Fungal cells; Protozoal cells 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A61K2039/541—Mucosal route
    • 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
    • A61K2039/55544—Bacterial toxins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

A vaccine delivered by transcutaneous immunization provides an effective treatment against infections by pathogens such as, for example, enterotoxigenic Escherichia coli (ETEC) and/or for symptoms of diarrheal disease caused thereby. For example, one, two, three, four, five or more antigens derived from ETEC and capable of inducing an antigen-specific immune response (e.g., toxins, colonization or virulence factors) and one or more optional adjuvant (e.g., whole bacterial ADP-ribosylating exotoxins, B
subunits or toxoids thereof, detoxified mutants and derivatives thereof) are used to manufacture vaccines or to induce systemic and/or mucosal immunity.

Claims

We Claim:

1. An immunogen for transcutaneous immunization, wherein said immunogen is comprised of one or more antigens in effective amounts to induce an immune response against one or more strains of enterotoxigenic Escherichia coli (ETEC).

2. An immunogen according to Claim 1 further comprising at least one adjuvant.

3. An immunogen according to Claim 2, wherein the adjuvant is an ADP-ribosylating exotoxin or a derivative thereof having adjuvant activity.

4. An immunogen according to Claim 1, wherein the adjuvant is selected from the group consisting of cholera toxin (CT), Escherichia coli heat-labile enterotoxin (LT), and mutants thereof having adjuvant activity.

5. An immunogen according to any one of Claims 1-4, wherein at least one of said antigens induces an immune response against an E. coli colonization factor antigen (CFA).

6. An immunogen according to Claim 5, wherein the E. coli colonization factor antigen is selected from the group consisting of CFA/I, CS1, CS2, CS3, CS4, CS5, CS6, CS17, and PCF 0166.

7. An immunogen according to any one of Claims 1-4, wherein at least one of said antigens induces an immune response against E. coli enterotoxin STa.

8. An immunogen according to any one of Claims 1-4, wherein the one or more antigens induce an immune response against at least CS3 and CS6; CS3 and CFA/I;
CS6 and CFA/I; CS3 and STa; CS6 and STa; or CFA/I and STa.

9. An immunogen according to any one of Claims 1-4, wherein the one or more antigens induce an immune response against at least CFA/I, CS3 and CS6; CF3, and STa; CFA/I, CS3 and STa; CFA/I, CS6 and STa; or CFA/I, CS3, CS6 and STa.

10. A vaccine suitable for transcutaneous immunization, wherein said vaccine is comprised of a patch and an immunogen according to any one of Claims 1-9.

11. A subunit vaccine suitable for transcutaneous immunization, wherein said vaccine is comprised of an immunogen according to any one of Claims 1-9 which is chemically synthesized, recombinantly produced, at least partially purified, or combinations thereof in cell-free form.

12. A whole-cell vaccine suitable for transcutaneous immunization, wherein said vaccine is comprised of an immunogen according to any one of Claims 1-9 in whole-cell form.

13. Use of immunogen or vaccine according to any one of Claims 1-12 to induce an immune response against one or more strains of ETEC.

14. Use of immunogen or vaccine according to any one of Claims 1-12 to treat and/or prevent one or more disease symptoms associated with traveler's diarrhea.

15. The use according to Claim 13 or 14 further comprising chemical and/or physical penetration enhancement.

16. Use of effective amounts of one or more antigens for manufacture of an immunogen or vaccine which induces an immune response against one or more strains of ETEC by transcutaneous immunization.

17. Use of effective amounts of at least one adjuvant and one or more antigens for manufacture of an immunogen or vaccine which induces an immune response against one or more strains of ETEC by transcutaneous immunization.
CA2437899A 2001-02-13 2002-02-13 Vaccine for transcutaneous immunization against etec-caused traveler's diarrhea Expired - Fee Related CA2437899C (en)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US26801601P 2001-02-13 2001-02-13
US60/268,016 2001-02-13
US30411001P 2001-07-11 2001-07-11
US60/304,110 2001-07-11
US31048301P 2001-08-08 2001-08-08
US31044701P 2001-08-08 2001-08-08
US60/310,483 2001-08-08
US60/310,447 2001-08-08
PCT/US2002/004254 WO2002064162A2 (en) 2001-02-13 2002-02-13 Vaccine for transcutaneous immunization

Publications (2)

Publication Number Publication Date
CA2437899A1 true CA2437899A1 (en) 2002-08-22
CA2437899C CA2437899C (en) 2012-05-15

Family

ID=27500924

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2437899A Expired - Fee Related CA2437899C (en) 2001-02-13 2002-02-13 Vaccine for transcutaneous immunization against etec-caused traveler's diarrhea

Country Status (12)

Country Link
US (1) US7527802B2 (en)
EP (1) EP1372708B1 (en)
JP (2) JP2005504002A (en)
AT (1) ATE398461T1 (en)
AU (1) AU2002250071B2 (en)
CA (1) CA2437899C (en)
CY (1) CY1111030T1 (en)
DE (1) DE60227157D1 (en)
DK (1) DK1372708T3 (en)
ES (1) ES2310201T3 (en)
PT (1) PT1372708E (en)
WO (1) WO2002064162A2 (en)

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