US20210403879A1 - Method for inactivating zika virus and related methods - Google Patents
Method for inactivating zika virus and related methods Download PDFInfo
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- US20210403879A1 US20210403879A1 US16/768,550 US201816768550A US2021403879A1 US 20210403879 A1 US20210403879 A1 US 20210403879A1 US 201816768550 A US201816768550 A US 201816768550A US 2021403879 A1 US2021403879 A1 US 2021403879A1
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- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/12—Viral antigens
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- 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
- A61P31/14—Antivirals for RNA viruses
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/08—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from viruses
- C07K16/10—RNA viruses
- C07K16/116—Togaviridae (F); Matonaviridae (F); Flaviviridae (F)
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- C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
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- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
- C12Q1/22—Testing for sterility conditions
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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
- A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
- A61K2039/525—Virus
- A61K2039/5252—Virus inactivated (killed)
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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
- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
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- C—CHEMISTRY; METALLURGY
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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- C—CHEMISTRY; METALLURGY
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- C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
- C12N2770/00011—Details
- C12N2770/24011—Flaviviridae
- C12N2770/24111—Flavivirus, e.g. yellow fever virus, dengue, JEV
- C12N2770/24121—Viruses as such, e.g. new isolates, mutants or their genomic sequences
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- C—CHEMISTRY; METALLURGY
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- C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
- C12N2770/00011—Details
- C12N2770/24011—Flaviviridae
- C12N2770/24111—Flavivirus, e.g. yellow fever virus, dengue, JEV
- C12N2770/24134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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- C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
- C12N2770/00011—Details
- C12N2770/24011—Flaviviridae
- C12N2770/24111—Flavivirus, e.g. yellow fever virus, dengue, JEV
- C12N2770/24151—Methods of production or purification of viral material
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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- C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
- C12N2770/00011—Details
- C12N2770/24011—Flaviviridae
- C12N2770/24111—Flavivirus, e.g. yellow fever virus, dengue, JEV
- C12N2770/24161—Methods of inactivation or attenuation
- C12N2770/24163—Methods of inactivation or attenuation by chemical treatment
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/62—Detectors specially adapted therefor
- G01N30/74—Optical detectors
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- 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
Definitions
- FIG. 19 shows the serum viremia of individual AG129 mice three days post-challenge, reported as PFU/mL.
- FIG. 25 shows compiled kinetics of inactivation data. Data compares infectious potency (TCID50) to RNA copy, and completeness of inactivation (COI) for samples from the four toxicology lots. These data indicate that the sensitivity of the COI assay is greater than TCID50.
- WO 97/37000 and WO 97/37001 describe the production of animal cells and cell lines that are capable of growth in suspension and in serum free media and are useful in the production and replication of viruses.
- the cells used for growing the at least one virus are Vero cells.
- the viral inoculum and the viral culture are preferably free from (i.e. will have been tested for and given a negative result for contamination by) herpes simplex virus, respiratory syncytial virus, parainfluenza virus 3, SARS coronavirus, adenovirus, rhinovirus, reoviruses, polyomaviruses, birnaviruses, circoviruses, and/or parvoviruses (WO 2006/027698).
- the numerical result of the multiplication of the formaldehyde concentration as measured in % (w/v) with the period of incubation with formaldehyde as measured in days is 0.025 to 0.5 and the formaldehyde concentration is 0.01% (w/v).
- the Zika virus preparation is treated with 0.008 to 0.015% (w/v) formalin for nine to eleven days at a temperature of 22° C. In some embodiments, the Zika virus preparation is treated with 0.008 to 0.015% (w/v) formalin for ten days at a temperature of 22° C. In some embodiments, the Zika virus preparation is treated with 0.01% (w/v) formalin for eight to twelve days at a temperature of 22° C. In some embodiments, the Zika virus preparation is treated with 0.01% (w/v) formalin for nine to eleven days at a temperature of 22° C. In some embodiments, the Zika virus preparation is treated with 0.01% (w/v) formalin for ten days at a temperature of 22° C.
- the vaccines and/or immunogenic compositions of the present disclosure containing one or more antigens from at least one inactivated Zika virus may be useful for treating or preventing Zika virus infection in a subject in need thereof and/or inducing an immune response, such as a protective immune response, against Zika virus in a subject in need thereof.
- the mixture of 50 parts of the composition comprising a virus which has been treated with formaldehyde with 1 part of 20% phosphoric acid and 2.5 parts of 1.0 mg/ml DNPH is incubated at a temperature of 18° C. to 30° C. for 10 to 30 minutes. In some embodiments the mixture of 50 parts of the composition comprising a virus which has been treated with formaldehyde with 1 part of 20% phosphoric acid and 2.5 parts of 1.0 mg/ml DNPH is incubated at a temperature of 18° C. to 30° C. for 15 to 25 minutes.
- the step of buffer exchange and/or dilution of the sample comprising the Zika virus preparation involves cross-flow filtration.
- cross-flow filtration which is also called tangential flow filtration the feed flow travels tangentially across the surface of the filter and not into the filter.
- the potency was determined by two different methods, TCID50 and plaque titration.
- the TCID50 was calculated by visual inspection of CPE (microscope) and by measuring the difference in absorbance (A 560 -A 420 ) of the wells displaying CPE (yellow in color) compared with red (no CPE). The plates were read on a plate reader, and applied to the same calculator as the microscopically read-plates (absorbance). The values in TCID50 between the two scoring techniques are quite similar, while the values obtained by plaque titration are lower.
- COI assay control The titer and back titration controls for this assay were performed using Vero indicator cells and scored in a TCID 50 96-well format with wells scored positive based on the media color change from pink to yellow, as a surrogate for cell death, or the presence of CPE.
- Virus titer control test Two independent replicates of the control virus (PRVABC59) of known titer were subjected to a 10-fold dilution series in media containing 2% FBS, and 100 ⁇ L of each dilution was added to four wells of a 96-well plate containing Vero cells.
- the method was validated in terms of specificity, linearity, accuracy, repeatability, intermediate precision, robustness, and stability of the sample.
- accuracy study the Zika vaccine drug product and aluminum hydroxide gel solution were spiked with a specific amount of formaldehyde, and the sample was mixed well by vortex before following the procedure described in Section 2.3.
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Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US16/768,550 US20210403879A1 (en) | 2017-11-30 | 2018-11-30 | Method for inactivating zika virus and related methods |
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762592995P | 2017-11-30 | 2017-11-30 | |
| PCT/US2018/059227 WO2019090233A2 (en) | 2017-11-03 | 2018-11-05 | Method for inactivating zika virus and for determining the completeness of inactivation |
| US16/768,550 US20210403879A1 (en) | 2017-11-30 | 2018-11-30 | Method for inactivating zika virus and related methods |
| PCT/US2018/063381 WO2019108976A1 (en) | 2017-11-30 | 2018-11-30 | Method for inactivating zika virus and related methods |
Related Parent Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2018/059227 Continuation-In-Part WO2019090233A2 (en) | 2017-11-03 | 2018-11-05 | Method for inactivating zika virus and for determining the completeness of inactivation |
| PCT/US2018/059227 Continuation WO2019090233A2 (en) | 2017-11-03 | 2018-11-05 | Method for inactivating zika virus and for determining the completeness of inactivation |
| PCT/US2018/063381 A-371-Of-International WO2019108976A1 (en) | 2017-11-30 | 2018-11-30 | Method for inactivating zika virus and related methods |
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| Application Number | Title | Priority Date | Filing Date |
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| US18/339,553 Continuation US20240024454A1 (en) | 2017-11-30 | 2023-06-22 | Method for inactivating zika virus and related methods |
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| US20210403879A1 true US20210403879A1 (en) | 2021-12-30 |
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| US16/768,550 Abandoned US20210403879A1 (en) | 2017-11-30 | 2018-11-30 | Method for inactivating zika virus and related methods |
| US16/768,499 Active 2039-01-17 US11975062B2 (en) | 2017-11-30 | 2018-11-30 | Zika vaccines and immunogenic compositions, and methods of using the same |
| US18/339,553 Abandoned US20240024454A1 (en) | 2017-11-30 | 2023-06-22 | Method for inactivating zika virus and related methods |
| US18/242,025 Abandoned US20240285747A1 (en) | 2017-11-30 | 2023-09-05 | Zika vaccines and immunogenic compositions, and methods of using the same |
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| Application Number | Title | Priority Date | Filing Date |
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| US16/768,499 Active 2039-01-17 US11975062B2 (en) | 2017-11-30 | 2018-11-30 | Zika vaccines and immunogenic compositions, and methods of using the same |
| US18/339,553 Abandoned US20240024454A1 (en) | 2017-11-30 | 2023-06-22 | Method for inactivating zika virus and related methods |
| US18/242,025 Abandoned US20240285747A1 (en) | 2017-11-30 | 2023-09-05 | Zika vaccines and immunogenic compositions, and methods of using the same |
Country Status (11)
| Country | Link |
|---|---|
| US (4) | US20210403879A1 (https=) |
| EP (2) | EP3717511A4 (https=) |
| JP (4) | JP2021505549A (https=) |
| KR (2) | KR20200094191A (https=) |
| CN (4) | CN111527104A (https=) |
| AU (5) | AU2018375789B2 (https=) |
| BR (2) | BR112020010466A2 (https=) |
| CA (2) | CA3084605A1 (https=) |
| MX (2) | MX2020005554A (https=) |
| SG (2) | SG11202004863QA (https=) |
| WO (2) | WO2019108976A1 (https=) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11478541B2 (en) | 2017-11-03 | 2022-10-25 | Takeda Vaccines, Inc. | Method for inactivating Zika virus and for determining the completeness of inactivation |
| US11975062B2 (en) | 2017-11-30 | 2024-05-07 | Takeda Vaccines, Inc. | Zika vaccines and immunogenic compositions, and methods of using the same |
| WO2024167866A3 (en) * | 2023-02-06 | 2025-01-09 | Cyanvac Llc | Modified piv5 vaccine vectors: methods of making and uses |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2020017765A1 (ko) * | 2018-07-18 | 2020-01-23 | (주)진매트릭스 | 지카 바이러스 변이주와 이를 포함한 지카 백신 조성물 |
| BR112021019845A2 (pt) * | 2019-05-08 | 2022-02-15 | Takeda Vaccines Inc | Composições de vírus inativado e formulações de vacina contra zika |
| RU2717993C1 (ru) * | 2019-10-22 | 2020-03-27 | Федеральное бюджетное учреждение науки "Государственный научный центр вирусологии и биотехнологии "Вектор" Федеральной службы по надзору в сфере защиты прав потребителей и благополучия человека (ФБУН ГНЦ ВБ "Вектор" Роспотребнадзора) | Способ получения антигена вируса Зика, обладающего иммуногенными и антигенными свойствами |
| EP4476329A1 (en) | 2022-02-09 | 2024-12-18 | Takeda Vaccines, Inc. | Zika vaccines and immunogenic compositions, and methods of using the same |
| CN121221758B (zh) * | 2025-12-02 | 2026-03-03 | 华诺泰生物医药科技(成都)有限公司 | 一种即用型稳定3d-mla佐剂溶液的制备方法 |
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| US11478541B2 (en) * | 2017-11-03 | 2022-10-25 | Takeda Vaccines, Inc. | Method for inactivating Zika virus and for determining the completeness of inactivation |
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| US11478541B2 (en) | 2017-11-03 | 2022-10-25 | Takeda Vaccines, Inc. | Method for inactivating Zika virus and for determining the completeness of inactivation |
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| WO2024167866A3 (en) * | 2023-02-06 | 2025-01-09 | Cyanvac Llc | Modified piv5 vaccine vectors: methods of making and uses |
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