DK200201473A - Composition useful for the transdermal delivery of the immunogen for generating an immunological response in an individual comprises at least one immunogen, an occlusion vehicle and an immunogen delivery system - Google Patents

Composition useful for the transdermal delivery of the immunogen for generating an immunological response in an individual comprises at least one immunogen, an occlusion vehicle and an immunogen delivery system Download PDF

Info

Publication number
DK200201473A
DK200201473A DK200201473A DKPA200201473A DK200201473A DK 200201473 A DK200201473 A DK 200201473A DK 200201473 A DK200201473 A DK 200201473A DK PA200201473 A DKPA200201473 A DK PA200201473A DK 200201473 A DK200201473 A DK 200201473A
Authority
DK
Denmark
Prior art keywords
immunogen
composition
delivery system
vehicle
occlusion vehicle
Prior art date
Application number
DK200201473A
Other languages
Danish (da)
Inventor
Nikolai Soeren Kirkby
Peter Boman Samuelsen
Original Assignee
Coloplast As
Pharomed As
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Coloplast As, Pharomed As filed Critical Coloplast As
Priority to DK200201473A priority Critical patent/DK200201473A/en
Priority to PCT/DK2003/000654 priority patent/WO2004030696A2/en
Priority to EP03750381A priority patent/EP1545605B8/en
Priority to DE60330257T priority patent/DE60330257D1/en
Priority to CNA2003801048116A priority patent/CN1735432A/en
Priority to NZ539008A priority patent/NZ539008A/en
Priority to DK03750381.0T priority patent/DK1545605T3/en
Priority to AT03750381T priority patent/ATE449612T1/en
Priority to JP2004540544A priority patent/JP2006503072A/en
Priority to AU2003269839A priority patent/AU2003269839B2/en
Priority to CA002500911A priority patent/CA2500911A1/en
Publication of DK200201473A publication Critical patent/DK200201473A/en
Priority to ZA200502605A priority patent/ZA200502605B/en

Links

Landscapes

  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

A composition comprises at least one immunogen, an occlusion vehicle and an immunogen delivery system in the form of a PosIntro (RTM) or an ISCOM. - Independent claims are included for the following: - (a) preparation of the composition involving introducing the immunogen and the immunogen delivery system, which are optionally comprised within a vaccine formulation into the matrix of the occlusion vehicle or on its surface by dispersion or soaking in a solution of the vehicle or by applying to its surface and optionally sterilizing, drying and/or seal packaging the composition; - (b) use of the immunogen for the preparation of the composition for the transdermal delivery of the immunogen containing an occlusion vehicle; and - (c) a construct comprising the composition. - ACTIVITY - Antimicrobial; Antibacterial; Immunostimulant. - MECHANISM OF ACTION - Vaccine. Test details are described, but no results given.

Description

P a t e n t k r a v: 1. Sammensætning til transdermal afgivelse af mindst ét immunogen til en person, omfattende a) mindst ét immunogen, b) et okkulsionsvehikel og c) et immunogenafgivelsessystem. 2. Sammensætning ifølge krav 1, hvor den transdermale afgivelse indbefatter afgivelse gennem en hudoverflade eller gennem et slimhindevæv. 3. Sammensætning ifølge krav 1 eller 2, hvor okklusionsvehiklet er et trykfølsomt klæbestof. 4. Sammensætning ifølge krav 3, hvor okklusionsvehiklet er et absorberende trykfølsomt klæbestof. 5. Sammensætning ifølge et hvilket som helst af krav 4, hvor okklusionsvehiklet er et hydrokolloid-klæbestof. 6. Sammensætning ifølge et hvilket som helst af krav 4, hvor okklusionsvehiklet er et hydrogel-klæbestof. 7. Sammensætning ifølge et hvilket som helst af krav 4, hvor okklusionsvehiklet er et tværbundet hydrogel-klæbestof. 8. Sammensætning ifølge et hvilket som helst af kravene fra 1 til 7, hvor immunogenet og immunogenafgivelsessystemet er fortrinsvis homogent fordelt i okklusionsvehiklet. 9. Sammensætning ifølge et hvilket som helst af kravene fra 1 til 7, hvor immunogenet og immunogenafgivelsessystemet er fordelt på overfladen af okklusionsvehiklet. 10. Sammensætning ifølge et hvilket som helst af kravene fra 1 til 9, hvor okklusionsvehiklet er et ikke-klæbende okklusionsvehikel, og ydermere omfattende et sekundært klæbestof, som er adskilt fra vehiklet, til fastgøring på huden. 11. Sammensætning ifølge krav 10, hvor okklusionsvehiklet er tørret eller lyofiliseret og indeholder en bærer, som omfatter et hydrofilt polymerstof eller en fedtlignende sammensætning. 12. Sammensætning ifølge et hvilket som helst af kravene fra 1 til 11, hvor okklusionsvehiklet eller det sekundære klæbestof er en tildækning, såsom en pude, et plaster, en forbinding eller lignende. 13. Sammensætning ifølge et hvilket som helst af krav 11 eller 12, som ydermere omfatter et reservoir med vand eller et andet passende opløsnings-/fortyndingsmiddel. 14. Sammensætning ifølge et hvilket som helst af krav 13, hvor vandreservoiret kan brydes, og vandet eller opløsnings-/fortyndingsmidlet kan absorberes i okklusionsvehiklet. 15. Sammensætning ifølge et hvilket som helst af kravene fra 1 til 14, som ydermere omfatter en hastighedsregulerende membran. 16. Sammensætning ifølge et hvilket som helst af kravene fra 1 til 15, hvor immunogenet og/eller immunogenafgivelsessystemet er adskilt fra hinanden. 17. Sammensætning ifølge et hvilket som helst af kravene fra 1 til 16, som ydermere omfatter en forstærker til transdermal lægemiddelafgivelse. 18. Sammensætning ifølge et hvilket som helst af kravene fra 1 til 17, hvor mindst det ene immunogen er valgt på en sådan måde, at det fremkaldte immunologiske respons er rettet mod ét eller flere antigener. 19. Sammensætning ifølge krav 18, hvor det ene eller flere antigener hidrører fra en mikroorganisme, fortrinsvis en patogen mikroorganisme, såsom en virus, en bakterie, en parasit og/eller en svamp. 20. Sammensætning ifølge et hvilket som helst af kravene fra 18 til 20, hvor immunogenet og/eller antigenet hidrører fra en virus. 21. Sammensætning ifølge krav 18, hvor det ene eller flere antigener hidrører fra en ikke-mikrobiel organisme, f.eks. fra et dyr såsom et hvirveldyr. 22. Sammensætning ifølge krav 21, hvor det ene eller flere antigener er syntetiske antigener, antigener hidrørende fra personen eller antigener hidrørende fra en hvilken som helst art. 23. Sammensætning ifølge et hvilket som helst af krav 19 eller 20, hvor det fremkaldte immunologiske respons bibringer personen beskyttelse mod en patogen mikroorganisme, som antigenet eller antigenerne udgøren del af. 24. Sammensætning ifølge et hvilket som helst af krav 19-20 eller 23, hvor det fremkaldte immunologiske respons kan træde i funktion, når personen efterfølgende udsættes for den patogene mikroorganisme. 25. Sammensætning ifølge et hvilket som helst af krav 19-20 eller 23-24, hvor det fremkaldte immunologiske respons er rettet mod en patogen bestanddel, som den patogene mikroorganisme har produceret, mens personen har været inficeret. 26. Sammensætning ifølge krav 25, hvor de patogene bestanddele er bakterielle toksiner såsom tetanus-toksin. 27. Sammensætning ifølge et hvilket som helst af kravene fra 1 til 26, hvor immunogenet og/eller antigenet omfatter eller består af i) ét eller flere identiske eller forskellige polypeptider og/eller peptider, hvilke polypeptider og/eller peptider valgfrit omfatter posttranslationelle modifikationer, ii) ét eller flere identiske eller forskellige lipopeptider, såsom polypeptider og/eller peptider, der er kemisk bundet til en lipidgruppe, iii) én eller flere identiske eller forskellige nukleinsyresekvenser eller sekvenser, som kan kode for polypeptider og/eller peptider, eller iv) ét eller flere identiske eller forskellige polysaccharider og/eller oligosaccharider, eller kombinationer af disse, og hvor immunogenet og/eller antigenet yderligere kan omdannes til fragmenter. 28. Sammensætning ifølge et hvilket som helst af kravene fra 1 til 27, hvor immunogenet og immunogenafgivelsessystemet er indeholdt i en vaccineformulering. 29. Sammensætning ifølge krav 28, hvor immunogenafgivelsessystemet er et Posintro eller et kationisk ISCOM. 30. Sammensætning ifølge krav 29, hvor immunogenafgivelsessystemet er et kompleks, som omfatter: i) mindst ét første sterol og/eller mindst ét andet sterol, hvor det mindst ene andet sterol er i stand til at kontakte et fremmed antigen, fortrinsvis en nukleinsyre, ved hjælp af en interaktion udvalgt blandt en elektrostatisk interaktion og en hydrofob interaktion, og hvor det mindst ene første sterol og/eller det mindst ene andet sterol er i stand til at danne et kompleks med mindst ét første saponin og/eller mindst ét andet saponin, og ii) mindst ét første saponin og/eller mindst ét andet saponin, hvor det mindst ene andet saponin er i stand til at kontakte en genetisk determinant ved hjælp af en interaktion udvalgt blandt en elektrostatisk interaktion og en hydrofob interaktion, og hvor det mindst ene første saponin og/eller det mindst ene andet saponin er i stand til at danne et kompleks med mindst ét første sterol og/eller mindst ét andet sterol, og, hvis det ønskes, iii) mindst én kontaktgruppe til at kontakte en genetisk determinant ved hjælp af en interaktion udvalgt blandt en elektrostatisk interaktion og en hydrofob interaktion, under den forudsætning, at den mindst ene kontaktgruppe er til stede, når der ikke er noget andet sterol og ikke noget andet saponin til stede i komplekset, og ydermere, hvis det ønskes, iv) mindst én lipofil del. 31. Fremgangsmåde til fremstilling af en sammensætning ifølge et hvilket som helst af kravene fra 1 til 30, omfattende trin, hvor immunogenet og immunogenafgivelsessystemet, som er valgfrit indeholdt i en vaccineformulering, tilføres ind i okklusionsvehiklets matrice eller på dets overflade ved dispersion eller udblødning i en opløsning af vehiklet eller ved påføring på dets overflade, og hvor sammensætningen valgfrit steriliseres og/eller tørres og/eller forseglingspakkes. 32. Fremgangsmåde ifølge krav 31, som ydermere omfatter trinnet, hvor immunogenet og immunogenafgivelsessystemet tørres eller lyofiliseres, før de tilføres til vehiklet. 33. Fremgangsmåde ifølge et hvilket som helst af krav 31 eller 32, som ydermere omfatter trinnet, hvor én eller flere forstærkere til transdermal lægemiddelafgivelse og/eller ét eller flere plastificeringsmidler tilsættes. 34. Konstruktion, som omfatter en sammensætning ifølge et hvilket som helst af kravene fra 1 til 30. 35. Konstruktion ifølge krav 34, som har ét eller flere kamre. 36. Konstruktion ifølge et hvilket som helst af krav 34 eller 35 med mindst to kamre, hvor et første kammer omfatter en lyofiliseret pude, som omfatter immunogenet og immunogenafgivelsessystemet, og et andet kammer omfatter vand eller et andet passende opløsnings-/fortyndingsmiddel. 37. Konstruktion ifølge et hvilket som helst af kravene fra 34 til 36, som omfatter mindst to adskilte bestanddele. 38. Fremgangsmåde til frembringelse af et immunologisk respons hos en person, hvorved personen indgives en sammensætning ifølge et hvilket som helst af kravene fra 1 til 30. 39. Fremgangsmåde til behandling eller forebyggelse af en sygdomstilstand hos en person, hvorved personen indgives en sammensætning ifølge et hvilket som helst af kravene fra 1 til 30. 40. Fremgangsmåde ifølge krav 39, hvorved tilstanden er en sygdom forårsaget af, at personen er blevet inficeret af en patogen mikroorganisme. 41. Fremgangsmåde til vaccination af en person, hvorved personen indgives en sammensætning ifølge et hvilket som helst af kravene fra 1 til 30. 42. Anvendelse af et immunogen til fremstillingen af en sammensætning til transdermal afgivelse af immunogenet, omfattende et okklusionsvehikel.A composition for transdermal delivery of at least one immunogen to a person, comprising a) at least one immunogen, b) an occlusion vehicle, and c) an immunogen delivery system. The composition of claim 1, wherein the transdermal delivery includes delivery through a skin surface or through a mucosal tissue. A composition according to claim 1 or 2, wherein the occlusion vehicle is a pressure sensitive adhesive. The composition of claim 3, wherein the occlusion vehicle is an absorbent pressure-sensitive adhesive. A composition according to any one of claims 4, wherein the occlusion vehicle is a hydrocolloid adhesive. The composition of any one of claims 4, wherein the occlusion vehicle is a hydrogel adhesive. A composition according to any one of claims 4, wherein the occlusion vehicle is a cross-linked hydrogel adhesive. A composition according to any one of claims 1 to 7, wherein the immunogen and immunogen delivery system are preferably homogeneously distributed in the occlusion vehicle. A composition according to any one of claims 1 to 7, wherein the immunogen and immunogen delivery system are distributed on the surface of the occlusion vehicle. A composition according to any one of claims 1 to 9, wherein the occlusion vehicle is a non-adhesive occlusion vehicle, and further comprising a secondary adhesive separate from the vehicle for attachment to the skin. The composition of claim 10, wherein the occlusion vehicle is dried or lyophilized and contains a carrier comprising a hydrophilic polymer substance or a fat-like composition. A composition according to any one of claims 1 to 11, wherein the occlusion vehicle or secondary adhesive is a cover such as a pillow, patch, dressing or the like. A composition according to any one of claims 11 or 12, further comprising a reservoir of water or other suitable solvent / diluent. A composition according to any one of claims 13, wherein the water reservoir can be broken and the water or solvent / diluent can be absorbed into the occlusion vehicle. A composition according to any one of claims 1 to 14, further comprising a speed regulating membrane. A composition according to any one of claims 1 to 15, wherein the immunogen and / or immunogen delivery system are separated from each other. A composition according to any one of claims 1 to 16, further comprising an transdermal drug delivery enhancer. A composition according to any one of claims 1 to 17, wherein at least one immunogen is selected in such a way that the induced immunological response is directed to one or more antigens. The composition of claim 18, wherein the one or more antigens are derived from a microorganism, preferably a pathogenic microorganism such as a virus, a bacterium, a parasite and / or a fungus. A composition according to any one of claims 18 to 20, wherein the immunogen and / or antigen are derived from a virus. The composition of claim 18, wherein the one or more antigens are derived from a non-microbial organism, e.g. from an animal such as a vertebrate. The composition of claim 21, wherein the one or more antigens are synthetic antigens, antigens derived from the person, or antigens derived from any species. A composition according to any one of claims 19 or 20, wherein the evoked immunological response confers protection against a pathogenic microorganism of which the antigen or antigens form part. A composition according to any one of claims 19-20 or 23, wherein the evoked immunological response can act when the subject is subsequently exposed to the pathogenic microorganism. A composition according to any one of claims 19-20 or 23-24, wherein the elicited immunological response is directed to a pathogenic component produced by the pathogenic microorganism while the subject has been infected. The composition of claim 25, wherein the pathogenic constituents are bacterial toxins such as tetanus toxin. A composition according to any one of claims 1 to 26, wherein the immunogen and / or antigen comprises or consists of i) one or more identical or different polypeptides and / or peptides, which polypeptides and / or peptides optionally comprise post-translational modifications; ii) one or more identical or different lipopeptides, such as polypeptides and / or peptides chemically linked to a lipid group, iii) one or more identical or different nucleic acid sequences or sequences which can encode polypeptides and / or peptides, or iv) one or more identical or different polysaccharides and / or oligosaccharides, or combinations thereof, and wherein the immunogen and / or antigen can be further converted into fragments. A composition according to any one of claims 1 to 27, wherein the immunogen and immunogen delivery system are contained in a vaccine formulation. The composition of claim 28, wherein the immunogen delivery system is a Posintro or a cationic ISCOM. The composition of claim 29, wherein the immunogen delivery system is a complex comprising: i) at least one first sterol and / or at least one second sterol, wherein the at least one second sterol is capable of contacting a foreign antigen, preferably a nucleic acid, by an interaction selected from an electrostatic interaction and a hydrophobic interaction, wherein the at least one first sterol and / or the at least one second sterol is capable of forming a complex with at least one first saponin and / or at least one second saponin and (ii) at least one first saponin and / or at least one second saponin, wherein the at least one other saponin is capable of contacting a genetic determinant by an interaction selected from an electrostatic interaction and a hydrophobic interaction, and wherein the at least one first saponin and / or at least one second saponin is capable of forming a complex with at least one first sterol and / or at least one second sterol and, if desired, es, (iii) at least one contact group to contact a genetic determinant by an interaction selected from an electrostatic interaction and a hydrophobic interaction, provided that the at least one contact group is present when no other sterol is present and not some other saponin present in the complex, and further, if desired, iv) at least one lipophilic moiety. A method of preparing a composition according to any one of claims 1 to 30, comprising steps wherein the immunogen and immunogen delivery system optionally contained in a vaccine formulation are introduced into the matrix of the occlusion vehicle or on its surface by dispersion or bleeding. a solution of the vehicle or by application to its surface and wherein the composition is optionally sterilized and / or dried and / or sealed. The method of claim 31, further comprising the step of drying or lyophilizing the immunogen and immunogen delivery system before being applied to the vehicle. The method of any one of claims 31 or 32, further comprising the step of adding one or more transdermal drug delivery enhancers and / or one or more plasticizers. A structure comprising a composition according to any one of claims 1 to 30. A structure according to claim 34 having one or more chambers. The structure of any of claims 34 or 35 having at least two chambers, wherein a first chamber comprises a lyophilized pad comprising the immunogen and immunogen delivery system, and a second chamber comprises water or another suitable solvent / diluent. Construction according to any one of claims 34 to 36, comprising at least two separate components. A method of generating an immunological response in a subject, wherein the subject is administered a composition according to any one of claims 1 to 30. 39. A method of treating or preventing a disease state in a subject, wherein the subject is administered a composition according to The method of claim 39, wherein the condition is a disease caused by the person being infected by a pathogenic microorganism. A method of vaccinating a subject, wherein the subject is administered a composition according to any one of claims 1 to 30. 42. Use of an immunogen for the preparation of a composition for transdermal delivery of the immunogen comprising an occlusion vehicle.

DK200201473A 2002-10-02 2002-10-02 Composition useful for the transdermal delivery of the immunogen for generating an immunological response in an individual comprises at least one immunogen, an occlusion vehicle and an immunogen delivery system DK200201473A (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
DK200201473A DK200201473A (en) 2002-10-02 2002-10-02 Composition useful for the transdermal delivery of the immunogen for generating an immunological response in an individual comprises at least one immunogen, an occlusion vehicle and an immunogen delivery system
NZ539008A NZ539008A (en) 2002-10-02 2003-10-02 Composition for vaccination by transdermal delivery
EP03750381A EP1545605B8 (en) 2002-10-02 2003-10-02 Composition for vaccination
DE60330257T DE60330257D1 (en) 2002-10-02 2003-10-02 COMPOSITION FOR VACCINATION
CNA2003801048116A CN1735432A (en) 2002-10-02 2003-10-02 Composition for vaccination
PCT/DK2003/000654 WO2004030696A2 (en) 2002-10-02 2003-10-02 Composition for vaccination
DK03750381.0T DK1545605T3 (en) 2002-10-02 2003-10-02 Composition for vaccination
AT03750381T ATE449612T1 (en) 2002-10-02 2003-10-02 COMPOSITION FOR VACCINATION
JP2004540544A JP2006503072A (en) 2002-10-02 2003-10-02 Vaccination composition
AU2003269839A AU2003269839B2 (en) 2002-10-02 2003-10-02 Composition for vaccination
CA002500911A CA2500911A1 (en) 2002-10-02 2003-10-02 Composition for vaccination
ZA200502605A ZA200502605B (en) 2002-10-02 2005-03-31 Composition for vaccination

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DK200201473A DK200201473A (en) 2002-10-02 2002-10-02 Composition useful for the transdermal delivery of the immunogen for generating an immunological response in an individual comprises at least one immunogen, an occlusion vehicle and an immunogen delivery system

Publications (1)

Publication Number Publication Date
DK200201473A true DK200201473A (en) 2004-04-03

Family

ID=32241189

Family Applications (1)

Application Number Title Priority Date Filing Date
DK200201473A DK200201473A (en) 2002-10-02 2002-10-02 Composition useful for the transdermal delivery of the immunogen for generating an immunological response in an individual comprises at least one immunogen, an occlusion vehicle and an immunogen delivery system

Country Status (3)

Country Link
CN (1) CN1735432A (en)
DK (1) DK200201473A (en)
ZA (1) ZA200502605B (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2007317206B2 (en) * 2006-11-10 2013-04-18 Ondek Pty Ltd Methods and devices for the delivery of peptides into the gastric mucosa
AP2013007242A0 (en) * 2011-04-20 2013-11-30 Mico Bio Inc Composition and method for enhancing an immune response

Also Published As

Publication number Publication date
ZA200502605B (en) 2006-06-28
CN1735432A (en) 2006-02-15

Similar Documents

Publication Publication Date Title
CN108601825B (en) Vaccine composition
JP4875799B2 (en) Use of skin permeation enhancers and barrier disintegrants to promote transdermal immune responses attracted by ADP-ribosylated exotoxins
JP2004529906A (en) Percutaneous immunostimulation
US20090136480A1 (en) Transcutaneous immunostimulation
CA2360692A1 (en) Noninvasive vaccination through the skin
CA2572870A1 (en) Delivery system for transdermal immunization
Schepens et al. Vaccination with influenza hemagglutinin-loaded ceramic nanoporous microneedle arrays induces protective immune responses
EP2679242B1 (en) Adjuvant for transdermal or transmucosal administration and pharmaceutical preparation containing same
Jeong et al. Preclinical study of influenza bivalent vaccine delivered with a two compartmental microneedle array
US10112979B2 (en) Influenza vaccination
KR20100093536A (en) Method and compositions for cutaneous immunisation
DK200201473A (en) Composition useful for the transdermal delivery of the immunogen for generating an immunological response in an individual comprises at least one immunogen, an occlusion vehicle and an immunogen delivery system
JP2008519042A5 (en)
Glenn et al. Transcutaneous immunization
US20130142878A1 (en) Peptide particle formulation
JPWO2008105504A1 (en) Transdermal immunization preparation, method for producing the same, and transdermal immunization method using the same
TWI564035B (en) Microneedle patch containing porcine vaccine
US20140105970A1 (en) Adjuvant and antigen particle formulation
WO2024068265A3 (en) Virus-like particles displaying sars-cov-2 antigens as booster vaccines and uses thereof
Sawicka Development of a Novel Immunization Platform
US20220356231A1 (en) Ehrlichia vaccines and immunogenic compositions
RU2286173C1 (en) Associated vaccine against anthrax and plague in cattle
WO2014044690A1 (en) Improved vaccines
WO2014159614A1 (en) Adjuvant and antigen particle formulation
IL180509A (en) Delivery system for transdermal immunization

Legal Events

Date Code Title Description
AHS Application shelved for other reasons than non-payment