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
  • A61K39/12—Viral antigens
  • A61K39/215—Coronaviridae, e.g. avian infectious bronchitis virus
• • C—CHEMISTRY; METALLURGY
  • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
  • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
  • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
• • 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)
• • 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
  • A61K2039/544—Mucosal route to the airways
• • 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
• • C—CHEMISTRY; METALLURGY
  • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
  • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
  • 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
  • C12N2770/20011—Coronaviridae
  • C12N2770/20034—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• • C—CHEMISTRY; METALLURGY
  • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
  • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
  • 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
  • C12N2770/20011—Coronaviridae
  • C12N2770/20051—Methods of production or purification of viral material
• • C—CHEMISTRY; METALLURGY
  • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
  • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
  • 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
  • C12N2770/20011—Coronaviridae
  • C12N2770/20061—Methods of inactivation or attenuation

Definitions

• the present invention relates to the field of providing vaccines for immunizing an individual against disease caused by a virus of the coronavirus family.
• the novel corona virus SARS-CoV-2 which can lead to Covid-19, is transmitted by droplet infection and can lead to an infection of the upper and lower respiratory tract. Such an infection leads to immunity relatively quickly.
• lymphatic organs such as the pharyngeal tonsils ("tonsils”), palate and tongue tonsils, which are grouped together in a quasi-circular manner around the pharynx, down to the larynx.
• tons pharyngeal tonsils
• tongue tonsils pharyngeal tonsils
• Such a “construction” of lymphatic organs can also be found at other ports of entry into the body, since these naturally represent a “gateway” for infections.
• Viruses are unable to multiply on their own. They need a host who will do this for them.
• the new type of coronavirus also docks onto host cells, here to human cells in the respiratory tract, infiltrates its RNA and ultimately induces an intracellular synthesis process via the infected cell, which aims to have all the "building blocks” of virus replication "outsourced”. At the end of the process, diverse virus copies are made available, which are released through degeneration of the affected cell.
• the organism is again flooded by numerous viruses, which helps to accentuate the clinical symptoms.
• the clinical symptoms are largely determined by the reaction of the immune system. In particular through the
• Class II HLA groups are intracellular peptides or antigens on the Cell surface presented. As a result of the intracellular virus attack, the intracellular protein signature changes and thus also the peptides or antigens presented by the HLA groups. If an immune cell (eg T-lymphocyte) identifies a virus-infected cell as "not normal”, an attack against this cell takes place via the inflammatory cascade with the aim of eliminating it.
• an immune cell eg T-lymphocyte
• an immunity (IgG, IgA and IgM antibodies against Covid-19) can only develop against surface structures / features (proteins) of the virus, certainly not against its specific RNA.
• Vaccines against novel viruses are generally not available when the virus appears.
• Conventional vaccinations have some disadvantages: They cannot be implemented quickly and easily with new types of virus. Insofar as they have an intrinsic effect (e.g. through injection), they have to overcome high and therefore lengthy hurdles for approval. Mass production is often expensive.
• methods for providing a vaccine are provided.
• the vaccine is used to immunize an individual against a virus caused by the Coronavirus family disease.
• a sample of the virus is obtained.
• the method further comprises inactivating the virus so that nucleic acids with genetic information of the virus are destroyed or removed.
• the inactivated virus is processed in order to obtain a ready-to-use vaccine for administration as an inhalable aerosol or as a gurgled solution.
• the virus can be SARS-CoV-2.
• the method further comprises culturing the virus of the sample obtained, in particular in a cell culture.
• the virus can be inactivated, for example, by irradiating the sample, in particular with UV rays.
• inactivating the virus can include applying a hypoosmolar environment.
• the nucleic acids of the virus can be removed.
• the method can further comprise enriching the vaccine with an immunization enhancer, e.g., aluminum hydroxide.
• an immunization enhancer e.g., aluminum hydroxide.
• the invention relates to a vaccine which has been provided by a method according to the first aspect.
• the invention relates to a use of a vaccine according to the second aspect.
• the use can include administration for single or multiple inhalation of the aerosol.
• FIG. 1 shows a flow chart of a method according to an exemplary embodiment.
• Methods are described for providing a vaccine for immunizing an individual against disease caused by a virus of the coronavirus family.
• 1 shows a method 10 for providing a vaccine for immunizing an individual against a disease caused by a virus of the coronavirus family.
• the method described as an example induces immunity against the disease Covid-19 without a clinically apparent or severe infection (especially without pneumonia) occurring.
• the methods described can be used for all viral diseases of the coronavirus family that are transmitted via droplet infection and the respiratory tract.
• the genetic material is a single-stranded DNA or RNA with 29,903 nucleotides. It codes for 10 proteins, with the SI protein responsible for binding the virus to a cell and the S2 protein for fusion with the cell membrane. These protein structures protrude like “spikes” from the fatty virus envelope, hence the designation "SI” or "S2". These spikes are about 9-12 nm long, the binding to the ACE-2 receptor of the host cell is essential for the infection / reduplication mediation of the virus
• a sample of the virus is obtained.
• the virus is propagated in a suitable cell culture.
• the virus is inactivated so that nucleic acids with genetic information of the virus are destroyed or removed.
• the virus and especially its RNA are inactivated by suitable measures (e.g. by irradiation). Alternatively, this can be achieved, for example, by swelling the virus with hypoosmolar culture solution, which causes it to burst. The RNA is removed and the fragments of the envelope are preserved.
• the inactivated virus or the virus envelope fragments is prepared in an aerosol for inhalation.
• the aerosol is enriched by an immunization enhancer, e.g. aluminum hydroxide.
• the immunization takes place by inhaling the aerosol, which can be repeated several times depending on the immunization effect.
• the aerosol can be inhaled by means of a burst of spray, for example through an inhaler or a nasal spray.
• the method of application can be modified: a gargle solution is possible, for example, so that the lower respiratory tract remains unaffected.
• “Ultravemeblem” can be used to produce very small droplets that can then penetrate deeper into the respiratory tract.
• This procedure can be adapted according to the individual reaction of the immune system (anti-Covid-19 antibody testing of immunoglobulins of class M, A and G in the blood), so immunization cycles can be repeated indefinitely. Clinical symptoms are not to be expected, if at all, and if they are, then only very slightly pronounced. Nevertheless, individual immunization can be achieved.
• RNA-inactivated virus will not trigger such an intense immune reaction as the native, infectious one. This is also not necessary, a subtle immunization is also helpful (so-called "silent celebration"). In any case, the effect can be intensified very carefully by increasing the number of sprays.
• Shell fragments will trigger a stronger immune response than an intact shell. The reason is that fragments present themselves to the immune system from “front and back”, ie from outside and inside. This increases the antigenic stimulus.
• the antigenic stimulus can also be increased by binding the fragments to proteins with strong antigenic properties, e.g. those of animal origin (e.g. bovine serum albumin).

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• Health & Medical Sciences (AREA)
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• Communicable Diseases (AREA)
• Epidemiology (AREA)
• Animal Behavior & Ethology (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
• Medicinal Preparation (AREA)
• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
• Micro-Organisms Or Cultivation Processes Thereof (AREA)

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• 2020
  • 2020-03-26 DE DE102020108453.6A patent/DE102020108453A1/de active Pending
• 2021
  • 2021-03-25 WO PCT/EP2021/057746 patent/WO2021191353A2/de active Application Filing
  • 2021-03-25 EP EP21715228.9A patent/EP4126024A2/de active Pending
  • 2021-03-25 CN CN202180024625.XA patent/CN115443149A/zh active Pending
  • 2021-03-25 JP JP2022558141A patent/JP2023518886A/ja active Pending
  • 2021-03-25 US US17/913,822 patent/US20240207388A1/en active Pending

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