# US 2010/0166802 A1 · Methods and reagents for decreasing clinical reaction to allergy

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- Number: US 2010/0166802 A1
- Document ID: US20100166802A1
- Status: Published application
- Kind: A1
- Application number: 12/572,599
- Filed: 2009-10-02
- Published: 2010-07-01
- Earliest claimed: 2000-04-06
- Assignees: University of Arkansas; Mount Sinai School of Medicine of New York University; Allertein Therapeutics, LLC
- Inventors: Michael J. Caplan; H. Kim Bottomly; Howard B. Sosin; A. Wesley Burks; Hugh A. Sampson
- Web page: https://patentgrep.com/patent/US20100166802A1

## CPC

- A61K 39/35: Allergens
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- A61K 2039/5156: {expressing foreign proteins}
- A61K 2039/523: {expressing foreign proteins}
- A61K 2039/5256: {expressing foreign proteins}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention provides methods and compositions for treating or preventing allergic reactions, particularly anaphylactic reactions. Methods of the present invention involve administering microorganisms to allergic subjects, where the microorganisms contain a recombinant version of the protein allergen. The recombinant version can be wild-type or may include mutations within IgE epitopes of the protein allergen. Preferably the compositions are administered rectally. Particularly preferred microorganisms are bacteria such as E. coli. Any allergen may be used in the inventive methods. Particularly preferred allergens are anaphylactic allergens including protein allergens found in foods, venoms, drugs and latex. The inventive compositions and methods are demonstrated in the treatment of peanut-induced anaphylaxis.

## Claims

### Claim 1

A method of treating allergy in a subject susceptible to an allergic response to a protein allergen selected from the group consisting of:
Ambrosia artemisiifolia (short ragweed) antigen E (Amb a 1);
Ambrosia artemisiifolia (short ragweed) antigen K (Amb a 2);
Ambrosia artemisiifolia (short ragweed) Ra3 antigen (Amb a 3);
Ambrosia artemisiifolia (short ragweed) Ra5 antigen (Amb a 5);
Ambrosia artemisiifolia (short ragweed) Ra6 antigen (Amb a 6);
Ambrosia artemisiifolia (short ragweed) Ra7 antigen (Amb a 7);
Ambrosia trifida (giant ragweed) Ra5G antigen (Amb t 5);
Artemisia vulgaris (mugwort) antigen (Art v 1);
Artemisia vulgaris (mugwort) antigen (Art v 2);
Helianthus annuus (sunflower) antigen (Hel a 1);
Helianthus annuus (sunflower) profilin (Hel a 2);
Mercurialis annua (annual mercury) profilin (Mer a 1);
Cynodon dactylon (Bermuda grass) antigen (Cyn d 1);
Cynodon dactylon (Bermuda grass) antigen (Cyn d 7);
Cynodon dactylon (Bermuda grass) profilin (Cyn d 12);
Dactylis glomerata (orchard grass) AgDg1 antigen (Dac g 1);
Dactylis glomerata (orchard grass) antigen (Dac g 2);
Dactylis glomerata (orchard grass) antigen (Dac g 3);
Dactylis glomerata (orchard grass) antigen (Dac g 5);
Holcus lanatus (velvet grass) antigen (Hol 1 1);
Lolium perenne (rye grass) group I antigen (Lol p 1);
Lolium perenne (rye grass) group II antigen (Lol p 2);
Lolium perenne (rye grass) group III antigen (Lol p 3);
Lolium perenne (rye grass) group IX antigen (Lol p 5);
Lolium perenne (rye grass) antigen (Lol p Ib);
Lolium perenne (rye grass) trypsin (Lol p 11);
Phalaris aquatica (canary grass) antigen (Pha a 1);
Phleum pratense (timothy grass) antigen (Ph1 p 1);
Phleum pratense (timothy grass) antigen (Ph1 p 2);
Phleum pratense (timothy grass) antigen (Ph1 p 4);
Phleum pratense (timothy grass) antigen Ag 25 (Ph1 p 5);
Phleum pratense (timothy grass) antigen (Ph1 p 6);
Phleum pratense (timothy grass) profilin (Ph1 p 12);
Phleum pratense (timothy grass) polygalacturonase (Ph1 p 13);
Poa pratensis (Kentucky blue grass) group I antigen (Poa p 1);
Poa pratensis (Kentucky blue grass) antigen (Poa p 5);
Sorghum halepense (Johnson grass) antigen (Sor h 1);
Alnus glutinosa (alder) antigen (Aln g 1);
Betula verrucosa (birch) antigen (Bet v 1);
Betula verrucosa (birch) profilin (Bet v 2);
Betula verrucosa (birch) antigen (Bet v 3);
Betula verrucosa (birch) antigen (Bet v 4);
Betula verrucosa (birch) isoflavone reductase homologue (Bet v 5);
Betula verrucosa (birch) cyclophilin (Bet v 7);
Carpinus betulus (hornbeam) antigen (Car b 1);
Castanea sativa (chestnut) Bet v 1 homologue (Cas s 1);
Castanea sativa (chestnut) chitinase (Cas s 5);
Corylus avelana (hazel) antigen (Cor a 1);
Quercus alba (white oak) antigen (Que a 1);
Cryptomeria japonica (sugi) antigen (Cry j 1);
Cryptomeria japonica (sugi) antigen (Cry j 2);
Juniperus ashei (mountain cedar) antigen (Jun a 1);
Juniperus ashei (mountain cedar) antigen (Jun a 3);
Juniperus oxycedrus (prickly juniper) calmodulin-like antigen (Jun o 2);
Juniperus sabinoides (mountain cedar) antigen (Jun s 1);
Juniperus virginiana (eastern red cedar) antigen (Jun v 1);
Fraxinus excelsior (ash) antigen (Fra e 1);
Ligustrum vulgare (privet) antigen (Lig v 1);
Olea europea (olive) antigen (Ole e 1);
Olea europea (olive) profilin (Ole e 2);
Olea europea (olive) antigen (Ole e 3);
Olea europea (olive) antigen (Ole e 4);
Olea europea (olive) superoxide dismutase (Ole e 5);
Olea europea (olive) antigen (Ole e 6);
Syringa vulgaris (lilac) antigen (Syr v 1);
Acarus siro (mite) fatty acid-binding protein (Aca s 13);
Blomia tropicalis (mite) antigen (Blo t 5);
Blomia tropicalis (mite) Bt11a antigen (Blo t 12);
Blomia tropicalis (mite) Bt6 fatty acid-binding protein (Blo t);
Dermatophagoides pteronyssinus (mite) antigen P1 (Der p 1);
Dermatophagoides pteronyssinus (mite) antigen (Der p 2);
Dermatophagoides pteronyssinus (mite) trypsin (Der p 3);
Dermatophagoides pteronyssinus (mite) amylase (Der p 4);
Dermatophagoides pteronyssinus (mite) antigen (Der p 5);
Dermatophagoides pteronyssinus (mite) chymotrypsin (Der p 6);
Dermatophagoides pteronyssinus (mite) antigen (Der p 7);
Dermatophagoides pteronyssinus (mite) glutathione transferase (Der p 8);
Dermatophagoides pteronyssinus (mite) collagenolytic serine prot. (Der p 9);
Dermatophagoides pteronyssinus (mite) tropomyosin (Der p 10);
Dermatophagoides pteronyssinus (mite) apolipophorin like p (Der p 14);
Dermatophagoides microceras (mite) antigen (Der m 1);
Dermatophagoides farinae (mite) antigen (Der f 1);
Dermatophagoides farinae (mite) antigen (Der f 2);
Dermatophagoides farinae (mite) antigen (Der f 3);
Dermatophagoides farinae (mite) tropomyosin (Der f 10);
Dermatophagoides farinae (mite) paramyosin (Der f 11);
Dermatophagoides farinae (mite) Mag 3, apolipophorin (Der f 14);
Euroglyphus maynei (mite) apolipophorin (Eur m 14);
Lepidoglyphus destructor (storage mite) antigen (Lep d 2.0101);
Lepidoglyphus destructor (storage mite) antigen (Lep d 2.0102);
Bos domesticus (cow) Ag3, lipocalin (Bos d 2);
Bos domesticus (cow) alpha-lactalbumin (Bos d 4);
Bos domesticus (cow) beta-lactalbumin (Bos d 5);
Bos domesticus (cow) serum albumin (Bos d 6);
Bos domesticus (cow) immunoglobulin (Bos d 7);
Bos domesticus (cow) casein (Bos d 8);
Canis familiaris (dog) antigen (Can f 1);
Canis familiaris (dog) antigen (Can f 2);
Canis familiaris (dog) albumin (Can f ?);
Equus caballus (horse) lipocalin (Equ c 1);
Equus caballus (horse) lipocalin (Equ c 2);
Felis domesticus (cat) cat-1 antigen (Fel d 1);
Mus musculus (mouse) MUP antigen (Mus m 1);
Rattus norvegius (rat) antigen (Rat n 1);
Alternaria alternata (fungus) antigen (Alt a 1);
Alternaria alternata (fungus) antigen (Alt a 2);
Alternaria alternata (fungus) heat shock protein (Alt a 3);
Alternaria alternata (fungus) ribosomal protein (Alt a 6);
Alternaria alternata (fungus) YCP4 protein (Alt a 7);
Alternaria alternata (fungus) aldehyde dehydrogenase (Alt a 10);
Alternaria alternata (fungus) enloase (Alt a 11);
Alternaria alternata (fungus) acid. ribosomal protein P1 (Alt a 12);
Cladosporium herbarum (fungus) antigen (Cla h 1);
Cladosporium herbarum (fungus) antigen (Cla h 2);
Cladosporium herbarum (fungus) aldehyde dehydrogenase (Cla h 3);
Cladosporium herbarum (fungus) ribosomal protein);
Cladosporium herbarum (fungus) YCP4 protein (Cla h 5);
Cladosporium herbarum (fungus) enolase (Cla h 6);
Cladosporium herbarum (fungus) acid. ribosomal protein P1 (Cla h 12);
Aspergillus flavus (fungus) alkaline serine proteinase (Asp fl 13);
Aspergillus Fumigatus (fungus) antigen (Asp f 1);
Aspergillus Fumigatus (fungus) antigen (Asp f 2);
Aspergillus Fumigatus (fungus) peroxisomal protein (Asp f 3);
Aspergillus Fumigatus (fungus) antigen (Asp f 4);
Aspergillus Fumigatus (fungus) metalloprotease (Asp f 5);
Aspergillus Fumigatus (fungus) Mn superoxide dismutase (Asp f 6);
Aspergillus Fumigatus (fungus) antigen (Asp f 7);
Aspergillus Fumigatus (fungus) ribosomal protein P2 (Asp f 8);
Aspergillus Fumigatus (fungus) antigen (Asp f 9);
Aspergillus Fumigatus (fungus) aspartis protease (Asp f 10);
Aspergillus Fumigatus (fungus) peptidyl-prolyl isomerase (Asp f 11);
Aspergillus Fumigatus (fungus) heat shock protein P70 (Asp f 12);
Aspergillus Fumigatus (fungus) alkaline serine proteinase (Asp f 13);
Aspergillus Fumigatus (fungus) antigen (Asp f 15);
Aspergillus Fumigatus (fungus) antigen (Asp f 16);
Aspergillus Fumigatus (fungus) antigen (Asp f 17);
Aspergillus Fumigatus (fungus) vacuolar serine (Asp f 18);
Aspergillus niger (fungus) beta-xylosidase (Asp n 14);
Aspergillus niger (fungus) antigen (Asp n 18);
Aspergillus niger (fungus) vacuolar serine proteinase;
Aspergillus oryzae (fungus) TAKA-amylase A (Asp o 2);
Aspergillus oryzae (fungus) alkaline serine proteinase (Asp o 13);
Penicillium brevicompactum (fungus) alkaline serine proteinase (Pen b 13);
Penicillium citrinum (fungus) heat shock protein P70 (Pen c 1);
Penicillium citrinum (fungus) peroxisomal membrane protein (Pen c 3);
Penicillium citrinum (fungus) alkaline serine proteinase (Pen c 13);
Penicillium notatum (fungus) N-acetyl glucosaminidase (Pen n 1);
Penicillium notatum (fungus) alkaline serine proteinase (Pen n 13);
Penicillium notatum (fungus) vacuolar serine proteinase (Pen n 18);
Penicillium oxalicum (fungus) vacuolar serine proteinase (Pen o 18);
Trichophyton rubrum (fungus) antigen (Tri r 2);
Trichophyton rubrum (fungus) serine protease (Tri r 4);
Trichophyton tonsurans (fungus) antigen (Tri t 1);
Trichophyton tonsurans (fungus) serine protease (Tri t 4);
Candida albicans (fungus) antigen (Cand a 1);
Candida boidinii (fungus) antigen (Cand b 2);
Malassezia furfur (fungus) antigen (Mal f 1);
Malassezia furfur (fungus) MF1 peroxisomal membrane protein (Mal f 2);
Malassezia furfur (fungus) MF2 peroxisomal membrane protein (Mal f 3);
Malassezia furfur (fungus) antigen (Mal f 4);
Malassezia furfur (fungus) antigen (Mal f 5);
Malassezia furfur (fungus) cyclophilin homologue (Mal f 6);
Psilocybe cubensis (fungus) antigen (Psi c 1);
Psilocybe cubensis (fungus) cyclophilin (Psi c 2);
Coprinus comatus (shaggy cap) antigen (Cop c 1);
Coprinus comatus (shaggy cap) antigen (Cop c 2);
Coprinus comatus (shaggy cap) antigen (Cop c 3);
Coprinus comatus (shaggy cap) antigen (Cop c 5);
Coprinus comatus (shaggy cap) antigen (Cop c 7);
Aedes aegyptii (mosquito) apyrase (Aed a 1);
Aedes aegyptii (mosquito) antigen (Aed a 2);
Apis mellifera (honey bee) phospholipase A2 (Api m 1);
Apis mellifera (honey bee) hyaluronidase (Api m 2);
Apis mellifera (honey bee) melittin (Api m 4);
Apis mellifera (honey bee) antigen (Api m 6);
Bombus pennsylvanicus (bumble bee) phospholipase (Bom p 1);
Bombus pennsylvanicus (bumble bee) protease (Bom p 4);
Blattella germanica (German cockroach) Bd9Ok (Bla g 1);
Blattella germanica (German cockroach) aspartic protease (Bla g 2);
Blattella germanica (German cockroach) calycin (Bla g 4);
Blattella germanica (German cockroach) glutathione transferase (Bla g 5);
Blattella germanica (German cockroach) troponin C (Bla g 6);
Periplaneta americana (American cockroach) Cr-PII (Per a 1);
Periplaneta americana (American cockroach) Cr-PI (Per a 3);
Periplaneta americana (American cockroach) tropomyosin (Per a 7);
Chironomus thummi thummi (midge) hemoglobin (Chi t 1-9);
Chironomus thummi thummi (midge) component III (Chi t 1.01);
Chironomus thummi thummi (midge) component IV (Chi t 1.02);
Chironomus thummi thummi (midge) component I (Chi t 2.0101);
Chironomus thummi thummi (midge) component IA (Chi t 2.0102);
Chironomus thummi thummi (midge) component II-beta (Ch t 3);
Chironomus thummi thummi (midge) component IIIA (Chi t 4);
Chironomus thummi thummi (midge) component VI (Chi t 5);
Chironomus thummi thummi (midge) component VIIA (Chi t 6.01);
Chironomus thummi thummi (midge) component IX (Chi t 6.02);
Chironomus thummi thummi (midge) component VIIB (Chi t 7);
Chironomus thummi thummi (midge) component VIII (Chi t 8);
Chironomus thummi thummi (midge) component X (Chi t 9);
Dolichovespula maculata (white face hornet) phospholipase (Dol m 1);
Dolichovespula maculata(white face hornet) hyaluronidase (Dol m 2);
Dolichovespula maculata (white face hornet) antigen 5 (Dol m 5);
Dolichovespula arenaria (yellow hornet) antigen 5 (Dol a 5);
Polistes annularies (wasp) phospholipase A1 (Pol a 1);
Polistes annularies (wasp) hyaluronidase (Pol a 2);
Polistes annularies (wasp) antigen 5 (Pol a 5);
Polistes dominulus (Mediterranean paper wasp) antigen (Pol d 1);
Polistes dominulus (Mediterranean paper wasp) serine protease (Pol d 4);
Polistes dominulus (Mediterranean paper wasp) antigen (Pol d 5);
Polistes exclamans (wasp) phospholipase A1 (Pol e 1);
Polistes exclamans (wasp) antigen 5 (Pol e 5);
Polistes fuscatus (wasp) antigen 5 (Pol f 5);
Polistes metricus (wasp) antigen 5 (Pol m 5);
Vespa crabo (European hornet) phospholipase (Vesp c 1);
Vespa crabo (European hornet) antigen 5 (Vesp c 5.0101);
Vespa crabo (European hornet) antigen 5 (Vesp c 5.0102);
Vespa mandarina (giant Asian hornet) antigen (Vesp m 1.01);
Vespa mandarina (giant Asian hornet) antigen (Vesp m 1.02);
Vespa mandarina (giant Asian hornet) antigen (Vesp m 5);
Vespula flavopilosa (yellowjacket) antigen 5 (Ves f 5);
Vespula germanica (yellowjacket) antigen 5 (Ves g 5);
Vespula maculifrons (yellowjacket) phospholipase A1 (Ves m 1);
Vespula maculifrons (yellowjacket) hyaluronidase (Ves m 2);
Vespula maculifrons (yellowjacket) antigen 5 (Ves m 5);
Vespula pennsylvanica (yellowjacket) (antigen 5Ves p 5);
Vespula squamosa (yellowjacket) antigen 5 (Ves s 5);
Vespula vidua (wasp) antigen (Ves vi 5);
Vespula vulgaris (yellowjacket) phospholipase A1 (Ves v 1);
Vespula vulgaris (yellowjacket) hyaluronidase (Ves v 2);
Vespula vulgaris (yellowjacket) antigen 5 (Ves v 5);
Myrmecia pilosula (Australian jumper ant) antigen (Myr p 1);
Myrmecia pilosula (Australian jumper ant) antigen (Myr p 2);
Solenopsis geminata (tropical fire ant) antigen (Sol g 2);
Solenopsis geminata (tropical fire ant) antigen (Sol g 4);
Solenopsis invicta (fire ant) antigen (Sol i 2);
Solenopsis invicta (fire ant) antigen (Sol i 3);
Solenopsis invicta (fire ant) antigen (Sol i 4);
Solenopsis saevissima (Brazilian fire ant) antigen (Sol s 2);
Gadus callarias (cod) allergen M (Gad c 1);
Salmo salar (Atlantic salmon) parvalbumin (Sal s 1);
Bos domesticus (cow) alpha-lactalbumin (Bos d 4);
Bos domesticus (cow) beta-lactalbumin (Bos d 5);
Bos domesticus (cow) serum albumin (Bos d 6);
Bos domesticus (cow) immunoglobulin (Bos d 7);
Bos domesticus (cow) casein (Bos d 8);
Gallus domesticus (chicken) ovomucoid (Gal d 1);
Gallus domesticus (chicken) ovalbumin (Gal d 2);
Gallus domesticus (chicken) conalbumin; A22 (Gal d 3);
Gallus domesticus (chicken) lysozyme (Gal d 4);
Gallus domesticus (chicken) serum albumin (Gal d 5);
Metapenaeus ensis (shrimp) tropomyosin (Met e 1);
Penaeus aztecus (shrimp) tropomyosin (Pen a 1);
Penaeus indicus (shrimp) tropomyosin (Pen i 1);
Todarodes pacificus (squid) tropomyosin (Tod p 1);
Haliotis Midae (abalone) antigen (Hal m 1);
Apium graveolens (celery) Bet v 1 homologue (Api g 1);
Apium graveolens (celery) profilin (Api g 4);
Apium graveolens (celery) antigen (Api g 5);
Brassica juncea (oriental mustard) 2S albumin (Bra j 1);
Brassica rapa (turnip) prohevein-like protein (Bar r 2);
Hordeum vulgare (barley) BMAI-1 (Hor v 1);
Zea mays (maize, corn) lipid transfer protein (Zea m 14);
Corylus avellana (hazelnut) Bet v 1 homologue (Cor a 1.0401);
Malus domestica (apple) Bet v 1 homologue (Mal d 1);
Malus domestica (apple) lipid transfer protein (Mal d 3);
Pyrus communis (pear) Bet v 1 homologue (Pyr c 1);
Pyrus communis (pear) profilin (Pyr c 4);
Pyrus communis (pear) isoflavone reductase homologue (Pyr c 5);
Oryza sativa (rice) antigen (Ory s 1);
Persea americana (avocado) endochitinase (Pers a 1);
Prunus armeniaca (apricot) Bet v 1 homologue (Pm ar 1);
Prunus armeniaca (apricot) lipid transfer protein (Pm ar 3);
Prunus avium (sweet cherry) Bet v 1 homologue (Pm av 1);
Prunus avium (sweet cherry) thaumatin homologue (Pm av 2);
Prunus avium (sweet cherry) profilin (Pm av 4);
Prunus persica (peach) lipid transfer protein (Pm p 3);
Sinapis alba (yellow mustard) 2S albumin (Sin a 1);
Glycine max (soybean) HPS (Gly m 1.0101);
Glycine max (soybean) HPS (Gly m 1.0102);
Glycine max (soybean) antigen (Gly m 2);
Glycine max (soybean) profilin (Gly m 3);
Arachis hypogaea (peanut) vicilin (Ar a h 1);
Arachis hypogaea (peanut) (conglutin Ar a h 2);
Arachis hypogaea (peanut) glycinin (Ar a h 3);
Arachis hypogaea (peanut) glycinin (Ar a h 4);
Arachis hypogaea (peanut) (profilin Ar a h 5);
Arachis hypogaea (peanut) conglutin homologue (Ar a h 6);
Arachis hypogaea (peanut) conglutin homologue (Ar a h 7);
Actinidia chinensis (kiwi) cysteine protease (Act c 1);
Solanum tuberosum (potato) patatin (Sol t 1);
Bertholletia excelsa (Brazil nut) 2S albumin (Ber e 1);
Juglans regia (English walnut) 2S albumin (Jug r 1);
Juglans regia (English walnut) vicilin (Jug r 2);
Ricinus communis (castor bean) 2S albumin (Ric c 1);
Anisakis simplex (nematode) antigen (Ani s 1);
Anisakis simplex (nematode) paramyosin (Ani s 2);
Ascaris suum (worm) antigen (Asc s 1);
Aedes aegyptii (mosquito) apyrase (Aed a 1);
Aedes aegyptii (mosquito) antigen (Aed a 2);
Hevea brasiliensis (rubber) elongation factor (Hey b 1);
Hevea brasiliensis (rubber) 1,3-glucanase (Hey b 2);
Hevea brasiliensis (rubber) antigen (Hey b 3);
Hevea brasiliensis (rubber) component of microhelix protein complex (Hey b 4);
Hevea brasiliensis (rubber) antigen (Hey b 5);
Hevea brasiliensis (rubber) hevein precursor (Hey b 6.01);
Hevea brasiliensis (rubber) hevein (Hey b 6.02);
Hevea brasiliensis (rubber) C-terminal fragment antigen (Hey b 6.03);
Hevea brasiliensis (rubber) patatin homologue (Hey b 7);
Hevea brasiliensis (rubber) profilin (Hey b 8);
Hevea brasiliensis (rubber) enolase (Hey b 9);
Hevea brasiliensis (rubber) Mn-superoxide dismut (Hey b 10);
Ctenocephalides felis felis (cat flea) antigen (Cte f 1);
Homo sapiens (human autoallergen) antigen (Hom s 1);
Homo sapiens (human autoallergen) antigen (Hom s 2);
Homo sapiens (human autoallergen) antigen (Hom s 3);
Homo sapiens (human autoallergen) antigen (Hom s 4); and
Homo sapiens (human autoallergen) antigen (Hom s 5),
the method comprising delivering via the rectum of the subject a therapeutically effective amount of a pharmaceutical composition, wherein the pharmaceutical composition comprises:
dead E. coli containing therein a recombinant version of the allergen; and
a pharmaceutically acceptable carrier.

### Claim 2 (depends on 1)

The method of claim 1, wherein the subject is a mammal.

### Claim 3 (depends on 1)

The method of claim 1, wherein the subject is a human.

### Claim 4 (depends on 1)

The method of claim 1, wherein in the step of delivering, the pharmaceutical composition is delivered in the form of a suppository.

### Claim 5 (depends on 1)

The method of claim 1, wherein in the step of delivering, the pharmaceutical composition is delivered in the form of an enema.

### Claim 6 (depends on 1)

The method of claim 1, wherein in the step of delivering, the pharmaceutical composition is delivered using a rectal catheter.

### Claim 7 (depends on 1)

The method of claim 1, further comprising a step of identifying a subject susceptible to an allergic response to a protein allergen, wherein the subject is identified as an individual with an elevated level of IgE antibodies that bind with the protein allergen.

### Claim 8 (depends on 1)

The method of claim 1, further comprising a step of identifying a subject susceptible to an allergic response to a protein allergen, wherein the subject is identified as an individual with a positive skin prick test to the protein allergen.

### Claim 9 (depends on 1)

The method of claim 1, further comprising a step of identifying a subject susceptible to an allergic response to a protein allergen, wherein the subject is identified as an individual having a characteristic selected from the group consisting of a prior display of allergic symptoms when exposed to the protein allergen and a familial relationship with an individual who previously displayed allergic symptoms when exposed to the protein allergen.

### Claim 10

A method of treating allergy in a subject susceptible to an allergic response to a protein allergen selected from the group consisting of peanut allergens Ara h 1, Ara h 2, and Ara h 3, the method comprising delivering via the rectum of the subject a therapeutically effective amount of a pharmaceutical composition, wherein the pharmaceutical composition comprises:
dead E. coli containing therein a recombinant version of the allergen; and
a pharmaceutically acceptable carrier.

### Claim 11 (depends on 10)

The method of claim 10, wherein the peanut allergen has an amino acid sequence selected from the group consisting of SEQ ID NO:2, SEQ ID NO:4 and SEQ ID NO:6.

### Claim 12 (depends on 10, 11)

The method of claim 10 or 11, wherein the recombinant version of the protein allergen is a wild-type recombinant allergen.

### Claim 13 (depends on 10, 11)

The method of claim 10 or 11, wherein the recombinant version of the protein allergen is a mutant recombinant allergen that includes exactly the same amino acid sequence as the protein allergen except that at least one amino acid has been mutated in at least one IgE epitope of the protein allergen.

### Claim 14 (depends on 10, 11)

The method of claim 10 or 11, wherein the subject is a mammal.

### Claim 15 (depends on 10, 11)

The method of claim 10 or 11, wherein the subject is a human.

### Claim 16 (depends on 10, 11)

The method of claim 10 or 11, wherein in the step of delivering, the pharmaceutical composition is delivered in the form of a suppository.

### Claim 17 (depends on 10, 11)

The method of claim 10 or 11, wherein in the step of delivering, the pharmaceutical composition is delivered in the form of an enema.

### Claim 18 (depends on 10, 11)

The method of claim 10 or 11, wherein in the step of delivering, the pharmaceutical composition is delivered using a rectal catheter.

### Claim 19 (depends on 10, 11)

The method of claim 10 or 11, further comprising a step of identifying a subject susceptible to an allergic response to a protein allergen, wherein the subject is identified as an individual with an elevated level of IgE antibodies that bind with the protein allergen.

### Claim 20 (depends on 10, 11)

The method of claim 10 or 11, further comprising a step of identifying a subject susceptible to an allergic response to a protein allergen, wherein the subject is identified as an individual with a positive skin prick test to the protein allergen.

### Claim 21 (depends on 10, 11)

The method of claim 10 or 11, further comprising a step of identifying a subject susceptible to an allergic response to a protein allergen, wherein the subject is identified as an individual having a characteristic selected from the group consisting of a prior display of allergic symptoms when exposed to the protein allergen and a familial relationship with an individual who previously displayed allergic symptoms when exposed to the protein allergen.