A composition for spraying a nasal vaccine for simultaneous action on the nasal mucosa and nasopharynx

Claims

1. A composition for spraying a nasal vaccine, comprising an antigen and a composition base obtained by adding polyethylene glycol to cross-linked polyacrylic acid.

2. The composition according to claim 1, wherein the polyethylene glycol is macrogol 400 and / or macrogol 4000, and the relative content of polyethylene glycol is 0.1-10.0 wt. / wt.% based on the composition base.

3. The composition according to claim 1 or 2, wherein the arrangement of crosslinks and the crosslinking density in the crosslinked polyacrylic acid are controlled so that the content of carboxyl groups in the crosslinked polyacrylic acid is 60.0-62.0 wt. / wt.%, and the crosslinked polyacrylic acid is a carboxyvinyl polymer with a high crosslinking density to such an extent that it does not cause curling.

4. The composition according to any one of claims 1-3, wherein the composition base is obtained by thickening cross-linked polyacrylic acid using an inorganic base and / or a basic amino acid, adjusting the viscosity of the thickened substance using a viscosity modulator and / or an external shear force, and then adding polyethylene glycol to the resulting substance, and said composition base has an optimized spray pattern that allows the composition base to simultaneously act on the nasal mucosa and nasopharynx.

5. The composition according to claim 4, wherein the inorganic base is sodium hydroxide, potassium hydroxide, sodium salt of a weak inorganic acid and / or potassium salt of a weak inorganic acid, the essential amino acid is lysine, arginine, and / or ornithine, and The viscosity modulator is sodium chloride, potassium chloride and / or calcium chloride.

6. The composition according to any one of claims 1-5, wherein the antigen is a live or inactivated bacterium, virus, and / or mycoplasma.

7. The composition of claim 6, wherein the virus is COVID-19, severe acute respiratory syndrome (SARS), an influenza virus such as influenza type A / B, hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), varicella zoster virus, measles virus, mumps virus, poliovirus, rotavirus, adenovirus, herpes virus, human papillomavirus or rubella virus, and the bacterium is Streptococcus pneumoniae, Mycobacterium tuberculosis, Bordetella pertussis, Neisseria meningitidis, Haemophilus influenzae type b, Vibrio cholerae, or Corynebacterium diphtheriae.

8. The composition of any one of claims 1 to 5, wherein the antigen is a whole antigen, a split antigen, or a subunit antigen of an influenza virus.

9. The composition according to any one of claims 1-5, wherein the antigen is an inactivated whole COVID-19 antigen, a recombinant protein antigen thereof, or various viral vectors comprising genes encoding antigenic proteins.

10. The composition according to any one of claims 1-5, wherein the antigen is a hepatitis B surface antigen (HBs antigen) and / or a hepatitis B nucleocapsid antigen (HBc antigen).

11. A composition base used in a composition for spraying a nasal vaccine, which is obtained by adding polyethylene glycol to cross-linked polyacrylic acid.

12. A system for intranasal administration of a vaccine, comprising a spray device in which a nozzle contacts the periphery of the external nostril to fix the direction of spraying, into which the composition according to any one of claims 1-10 is loaded.

13. A composition according to any one of claims 1-5, which is used for intranasal administration with a volume of one injection into the nose of 250-750 μl for simultaneous action on both the nasal mucosa and the nasopharynx.