EP2219670A2 - Universal vaccine for the treatment and prophylaxis of lyme disease for human and veterinary use and method of its manufacture - Google Patents
Universal vaccine for the treatment and prophylaxis of lyme disease for human and veterinary use and method of its manufactureInfo
- Publication number
- EP2219670A2 EP2219670A2 EP08850812A EP08850812A EP2219670A2 EP 2219670 A2 EP2219670 A2 EP 2219670A2 EP 08850812 A EP08850812 A EP 08850812A EP 08850812 A EP08850812 A EP 08850812A EP 2219670 A2 EP2219670 A2 EP 2219670A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- borrelia
- vaccine
- ospa
- ospc
- genomospecies
- Prior art date
- Legal status (The legal status 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 status listed.)
- Ceased
Links
- 208000016604 Lyme disease Diseases 0.000 title claims abstract description 75
- 229960005486 vaccine Drugs 0.000 title claims abstract description 70
- 241000282414 Homo sapiens Species 0.000 title claims abstract description 15
- 238000011321 prophylaxis Methods 0.000 title claims abstract description 10
- 238000011282 treatment Methods 0.000 title claims abstract description 9
- 238000004519 manufacturing process Methods 0.000 title claims description 22
- 238000000034 method Methods 0.000 title claims description 8
- 241000589968 Borrelia Species 0.000 claims abstract description 46
- 241000589969 Borreliella burgdorferi Species 0.000 claims abstract description 46
- 108700023315 OspC Proteins 0.000 claims abstract description 34
- 230000001681 protective effect Effects 0.000 claims abstract description 32
- 241001148604 Borreliella afzelii Species 0.000 claims abstract description 24
- 241001148605 Borreliella garinii Species 0.000 claims abstract description 23
- 230000002163 immunogen Effects 0.000 claims abstract description 17
- 108090000623 proteins and genes Proteins 0.000 claims abstract description 17
- 102000004169 proteins and genes Human genes 0.000 claims abstract description 16
- 239000012528 membrane Substances 0.000 claims abstract description 11
- 108700006640 OspA Proteins 0.000 claims abstract description 10
- 230000001580 bacterial effect Effects 0.000 claims abstract description 10
- 239000006166 lysate Substances 0.000 claims abstract description 4
- 239000000427 antigen Substances 0.000 claims description 22
- 108091007433 antigens Proteins 0.000 claims description 22
- 102000036639 antigens Human genes 0.000 claims description 22
- 230000036039 immunity Effects 0.000 claims description 19
- 230000001717 pathogenic effect Effects 0.000 claims description 11
- 239000002671 adjuvant Substances 0.000 claims description 8
- 239000007788 liquid Substances 0.000 claims description 4
- 229910052500 inorganic mineral Inorganic materials 0.000 claims description 3
- 239000011707 mineral Substances 0.000 claims description 3
- 238000002156 mixing Methods 0.000 claims description 3
- 239000002955 immunomodulating agent Substances 0.000 claims description 2
- 229940121354 immunomodulator Drugs 0.000 claims description 2
- 101710105714 Outer surface protein A Proteins 0.000 description 36
- 208000015181 infectious disease Diseases 0.000 description 22
- 238000002255 vaccination Methods 0.000 description 15
- 241000282326 Felis catus Species 0.000 description 14
- 238000012360 testing method Methods 0.000 description 13
- 241000282472 Canis lupus familiaris Species 0.000 description 12
- 201000010099 disease Diseases 0.000 description 12
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 12
- 241001465754 Metazoa Species 0.000 description 11
- 210000004369 blood Anatomy 0.000 description 10
- 239000008280 blood Substances 0.000 description 10
- 241000238876 Acari Species 0.000 description 9
- 241000283086 Equidae Species 0.000 description 9
- 239000002609 medium Substances 0.000 description 9
- 238000002360 preparation method Methods 0.000 description 9
- 108010052285 Membrane Proteins Proteins 0.000 description 8
- 102000018697 Membrane Proteins Human genes 0.000 description 8
- 241000699670 Mus sp. Species 0.000 description 8
- 230000003053 immunization Effects 0.000 description 8
- 210000002966 serum Anatomy 0.000 description 8
- 238000002224 dissection Methods 0.000 description 7
- 238000002649 immunization Methods 0.000 description 7
- 241000699800 Cricetinae Species 0.000 description 6
- 230000009471 action Effects 0.000 description 6
- 238000011161 development Methods 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- 239000001963 growth medium Substances 0.000 description 6
- 208000024891 symptom Diseases 0.000 description 6
- 241000283973 Oryctolagus cuniculus Species 0.000 description 5
- 238000011156 evaluation Methods 0.000 description 5
- 238000012770 revaccination Methods 0.000 description 5
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 4
- 241000282412 Homo Species 0.000 description 4
- 241001480843 Ixodes ricinus Species 0.000 description 4
- 206010003246 arthritis Diseases 0.000 description 4
- 229940042470 lyme disease vaccine Drugs 0.000 description 4
- 238000007390 skin biopsy Methods 0.000 description 4
- 239000013598 vector Substances 0.000 description 4
- 241000908522 Borreliella Species 0.000 description 3
- 108010033266 Lipoprotein(a) Proteins 0.000 description 3
- 241000589973 Spirochaeta Species 0.000 description 3
- 238000010171 animal model Methods 0.000 description 3
- 230000015572 biosynthetic process Effects 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 230000006698 induction Effects 0.000 description 3
- 230000036512 infertility Effects 0.000 description 3
- 230000007774 longterm Effects 0.000 description 3
- 210000000056 organ Anatomy 0.000 description 3
- 241000894007 species Species 0.000 description 3
- 229940031626 subunit vaccine Drugs 0.000 description 3
- 238000003786 synthesis reaction Methods 0.000 description 3
- 206010061591 Borrelia infection Diseases 0.000 description 2
- 108010041986 DNA Vaccines Proteins 0.000 description 2
- 229940021995 DNA vaccine Drugs 0.000 description 2
- 238000012369 In process control Methods 0.000 description 2
- 238000013494 PH determination Methods 0.000 description 2
- 108010008281 Recombinant Fusion Proteins Proteins 0.000 description 2
- 102000007056 Recombinant Fusion Proteins Human genes 0.000 description 2
- 210000001744 T-lymphocyte Anatomy 0.000 description 2
- 239000003708 ampul Substances 0.000 description 2
- 230000000890 antigenic effect Effects 0.000 description 2
- 229940030156 cell vaccine Drugs 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000011109 contamination Methods 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 230000005847 immunogenicity Effects 0.000 description 2
- 238000010965 in-process control Methods 0.000 description 2
- 230000002779 inactivation Effects 0.000 description 2
- 238000011534 incubation Methods 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 150000002632 lipids Chemical group 0.000 description 2
- 244000005700 microbiome Species 0.000 description 2
- 229910052757 nitrogen Inorganic materials 0.000 description 2
- 235000015097 nutrients Nutrition 0.000 description 2
- 229940099789 ospa protein Drugs 0.000 description 2
- 239000013612 plasmid Substances 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- 230000004044 response Effects 0.000 description 2
- 238000005070 sampling Methods 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 238000012546 transfer Methods 0.000 description 2
- 208000030507 AIDS Diseases 0.000 description 1
- 108700028369 Alleles Proteins 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 101001086191 Borrelia burgdorferi Outer surface protein A Proteins 0.000 description 1
- 101900341263 Borrelia burgdorferi Outer surface protein A Proteins 0.000 description 1
- 241000589977 Borrelia turicatae Species 0.000 description 1
- 101100180402 Caenorhabditis elegans jun-1 gene Proteins 0.000 description 1
- 241000282465 Canis Species 0.000 description 1
- 101710098119 Chaperonin GroEL 2 Proteins 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- 101710181478 Envelope glycoprotein GP350 Proteins 0.000 description 1
- 241000283073 Equus caballus Species 0.000 description 1
- 206010062488 Erythema migrans Diseases 0.000 description 1
- 241000588724 Escherichia coli Species 0.000 description 1
- 108010040721 Flagellin Proteins 0.000 description 1
- 108010046732 HLA-DR4 Antigen Proteins 0.000 description 1
- 102000057248 Lipoprotein(a) Human genes 0.000 description 1
- 108090001030 Lipoproteins Proteins 0.000 description 1
- 102000004895 Lipoproteins Human genes 0.000 description 1
- 101710117393 Membrane-associated lipoprotein Proteins 0.000 description 1
- 206010029260 Neuroblastoma Diseases 0.000 description 1
- 101710105715 Outer surface protein B Proteins 0.000 description 1
- 101710105711 Outer surface protein C Proteins 0.000 description 1
- 241000283984 Rodentia Species 0.000 description 1
- 241000589970 Spirochaetales Species 0.000 description 1
- 208000035056 Tick-Borne disease Diseases 0.000 description 1
- 206010000210 abortion Diseases 0.000 description 1
- 231100000176 abortion Toxicity 0.000 description 1
- 230000000240 adjuvant effect Effects 0.000 description 1
- VREFGVBLTWBCJP-UHFFFAOYSA-N alprazolam Chemical compound C12=CC(Cl)=CC=C2N2C(C)=NN=C2CN=C1C1=CC=CC=C1 VREFGVBLTWBCJP-UHFFFAOYSA-N 0.000 description 1
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical group [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 description 1
- 229910021502 aluminium hydroxide Inorganic materials 0.000 description 1
- SMYKVLBUSSNXMV-UHFFFAOYSA-K aluminum;trihydroxide;hydrate Chemical compound O.[OH-].[OH-].[OH-].[Al+3] SMYKVLBUSSNXMV-UHFFFAOYSA-K 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 230000027645 antigenic variation Effects 0.000 description 1
- 230000005784 autoimmunity Effects 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 239000006161 blood agar Substances 0.000 description 1
- 230000036760 body temperature Effects 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 230000001066 destructive effect Effects 0.000 description 1
- 238000001962 electrophoresis Methods 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 230000004927 fusion Effects 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 238000000265 homogenisation Methods 0.000 description 1
- 230000004727 humoral immunity Effects 0.000 description 1
- 230000002134 immunopathologic effect Effects 0.000 description 1
- 229940031551 inactivated vaccine Drugs 0.000 description 1
- 230000002458 infectious effect Effects 0.000 description 1
- 239000002054 inoculum Substances 0.000 description 1
- 238000007912 intraperitoneal administration Methods 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 238000009533 lab test Methods 0.000 description 1
- 239000002502 liposome Substances 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 230000001404 mediated effect Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 238000007911 parenteral administration Methods 0.000 description 1
- 230000008506 pathogenesis Effects 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
- 208000007865 relapsing fever Diseases 0.000 description 1
- 239000013049 sediment Substances 0.000 description 1
- 238000012163 sequencing technique Methods 0.000 description 1
- 238000002415 sodium dodecyl sulfate polyacrylamide gel electrophoresis Methods 0.000 description 1
- 238000010186 staining Methods 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 208000016523 tick-borne infectious disease Diseases 0.000 description 1
- 201000006427 tick-borne relapsing fever Diseases 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 229940125575 vaccine candidate Drugs 0.000 description 1
- 239000003981 vehicle Substances 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
- 230000003612 virological effect Effects 0.000 description 1
- 230000009278 visceral effect Effects 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 238000001262 western blot Methods 0.000 description 1
Classifications
-
- 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
- A61K39/0225—Spirochetes, e.g. Treponema, Leptospira, Borrelia
-
- 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
- A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
- A61K2039/552—Veterinary vaccine
-
- 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
Definitions
- the whole-cell, chemically inactivated vaccine is applied with a vehicle containing polymer adjuvant substances.
- the vaccine is applied intramuscularly, twice in the interval of two or three weeks.
- a maintenance dose (booster) is recommended a year later.
- the vaccination of domestic animals, especially dogs, is recommended irrespective of whether the animal was infected or the disease is just in progress.
- the preparation of this vaccine was based on the knowledge acquired in experiments performed in rodents. The protective effect of the whole-cell vaccine was described in hamsters for the first time.
- Example no. 1 This example of execution demonstrates the verification of protectivity of the universal vaccine after immunization of experimental cats, dogs and horses against the challenge by virulent strains of Borrelia burgdorferi sensu lato, however, it in no case limits the patent rights related to this patent.
- the number of borrelias is determined in the dark field of microscope by means of the PETROFF HAUSSER COUNTING CHAMBER.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Microbiology (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- Immunology (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CZ20070791A CZ301244B6 (cs) | 2007-11-14 | 2007-11-14 | Univerzální vakcína k lécbe a prevenci Lymeské borreliózy pro humánní a veterinární použití a zpusob její výroby |
| PCT/CZ2008/000130 WO2009062454A2 (en) | 2007-11-14 | 2008-10-21 | Universal vaccine for the treatment and prophylaxis of lyme disease for human and veterinary use and method of its manufacture |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP2219670A2 true EP2219670A2 (en) | 2010-08-25 |
Family
ID=40600158
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP08850812A Ceased EP2219670A2 (en) | 2007-11-14 | 2008-10-21 | Universal vaccine for the treatment and prophylaxis of lyme disease for human and veterinary use and method of its manufacture |
Country Status (5)
| Country | Link |
|---|---|
| EP (1) | EP2219670A2 (cs) |
| CZ (1) | CZ301244B6 (cs) |
| RU (1) | RU2472525C2 (cs) |
| UA (1) | UA102081C2 (cs) |
| WO (1) | WO2009062454A2 (cs) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CZ301244B6 (cs) * | 2007-11-14 | 2009-12-16 | Bioveta, A.S. | Univerzální vakcína k lécbe a prevenci Lymeské borreliózy pro humánní a veterinární použití a zpusob její výroby |
| CZ301548B6 (cs) * | 2008-08-20 | 2010-04-14 | Bittner@Libor | Univerzální preparát ke zvýšení obranyschopnosti, prevenci, profylaxi a lécbe Lymeské boreliózy pro humánní a veterinární použití, zpusob jeho výroby a použití |
| RU2407787C1 (ru) * | 2009-08-13 | 2010-12-27 | Федеральное государственное учреждение науки "Омский научно-исследовательский институт природноочаговых инфекций" Федеральной службы по надзору в сфере защиты прав потребителей и благополучия человека | Штамм боррелий генотипа borrelia garinii nt 29, используемый для идентификации боррелий и приготовления диагностических препаратов |
| PL223175B1 (pl) | 2012-10-22 | 2016-10-31 | Inst Chemii Bioorganicznej Polskiej Akademii Nauk | Szczepionka przeciw boreliozie, konstrukt genetyczny, rekombinowane białko, sposób otrzymywania konstruktu genetycznego, sposób otrzymywania szczepionki, sposób otrzymywania rekombinowanych białek, zastosowanie rekombinowanych białek do wytwarzania szczepionki przeciwko boreliozie |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6872550B1 (en) * | 1991-07-11 | 2005-03-29 | Baxter Vaccine Ag | Immunogenic formulation of OspC antigen vaccines for the prevention and treatment of lyme disease and recombinant methods for the preparation of such antigens |
| RU2102081C1 (ru) * | 1991-07-11 | 1998-01-20 | Иммуно АГ | Иммуногенная композиция против боррелиоза лайма, способ иммунизации млекопитающего против боррелиоза лайма, способ получения белка pc borrelia burgdorferi, диагностический агент для обнаружения b.burgdorferi и способ обнаружения антител к b.burgdorferi |
| DK0701612T3 (da) * | 1993-04-29 | 1998-09-21 | Immuno Ag | Immunogent præparat af OspC-antigenvacciner til forebyggelse og behandling af Lyme sygdom og rekombinantmetode til fremsti |
| US7008625B2 (en) * | 1993-11-01 | 2006-03-07 | Research Foundation Of The State University Of New York | Recombinant constructs of Borrelia burgdorferi |
| DK0757556T3 (da) * | 1994-04-11 | 2006-10-02 | Wyeth Corp | Borrelia Burgdorferi-bakterin |
| US5846946A (en) * | 1996-06-14 | 1998-12-08 | Pasteur Merieux Serums Et Vaccins | Compositions and methods for administering Borrelia DNA |
| JP5177824B2 (ja) * | 2006-11-03 | 2013-04-10 | シェーリング−プラウ・リミテッド | イヌのライム病のワクチン |
| CZ301244B6 (cs) * | 2007-11-14 | 2009-12-16 | Bioveta, A.S. | Univerzální vakcína k lécbe a prevenci Lymeské borreliózy pro humánní a veterinární použití a zpusob její výroby |
-
2007
- 2007-11-14 CZ CZ20070791A patent/CZ301244B6/cs unknown
-
2008
- 2008-10-21 WO PCT/CZ2008/000130 patent/WO2009062454A2/en not_active Ceased
- 2008-10-21 EP EP08850812A patent/EP2219670A2/en not_active Ceased
- 2008-10-21 UA UAA201007218A patent/UA102081C2/ru unknown
- 2008-10-21 RU RU2010123897/15A patent/RU2472525C2/ru active
Non-Patent Citations (1)
| Title |
|---|
| See references of WO2009062454A2 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CZ2007791A3 (cs) | 2009-05-27 |
| RU2472525C2 (ru) | 2013-01-20 |
| WO2009062454A3 (en) | 2009-07-16 |
| RU2010123897A (ru) | 2011-12-20 |
| WO2009062454A2 (en) | 2009-05-22 |
| UA102081C2 (ru) | 2013-06-10 |
| CZ301244B6 (cs) | 2009-12-16 |
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