Influenza vaccine composition for sublingual mucosa delivery

A technology of influenza vaccine and composition, which is applied in the direction of microorganisms, biochemical equipment and methods, and medical preparations containing active ingredients, etc., which can solve the problems of insufficient immunogenicity, immune tolerance of SLIT administration, and induction of immune tolerance and other problems, to achieve the effect of fast and convenient use, benefiting large-scale immunization, and improving immune response

Pending Publication Date: 2021-07-16
LIAONING CHENGDA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the disadvantages of this technical solution are: since the olfactory nerve in the nasal cavity is associated with the central nervous system, there is a risk of drug transfer to the central nervous system through the olfactory nerve when nasal mucosa is administered, and there is also retention and impact on the lower respiratory tract Defects
However, the route of administration of SLIT vaccine has the following problems: ①The immunogenicity of sublingual administration is not enough; ②The mucosal immune system can induce immune tolerance
The disadvantage of this plan is that the article only mentions that adjuvants can be added to the vaccine on page 15, but it does not screen for the type and content of adjuvants to ensure that the immunogenicity of the vaccine can be improved
As another example, literature (Spinner JL, Oberoi H S, Yorgensen Y M, et al. Methylglycol chitosan and a synthetic TLR4agonist enhance immune responses to influenza vaccine administered sublingually [J]. Vaccine, 2015, 33 (43): 5845-5853.) explored Adding the adjuvant CRX-601, chitosan or a combination of the two to the influenza vaccine can improve the immunogenicity of the vaccine, but its disadvantage is that it does not solve the problem of immune tolerance in SLIT administration
However, a large number of studies have found that oral mucosal administration will produce immune tolerance. Once immune tolerance is established, specific antibodies cannot be produced, so that normal immune responses cannot be performed.
Unfortunately, the current literature on oral administration of virus vaccines has not explored the issue of immune tolerance caused by oral mucosal administration

Method used

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  • Influenza vaccine composition for sublingual mucosa delivery
  • Influenza vaccine composition for sublingual mucosa delivery
  • Influenza vaccine composition for sublingual mucosa delivery

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Preparation of Example 1 Influenza Vaccine Sublingual Rapidly Disintegrating Tablet

[0032] In order to facilitate the screening, the present invention makes the influenza vaccine composition into sublingual rapidly disintegrating tablets, and investigates the influencing factors on the immunogenicity and immune tolerance of the influenza vaccine. It should be noted that the focus of the present invention is to explore the relationship between the screening of adjuvants on the immunogenicity and immune tolerance of influenza vaccines, not to investigate the immunogenicity and immune tolerance of influenza vaccines by changing the application dosage form of the influenza vaccine composition. influence relationship. Therefore, the sublingual rapidly disintegrating tablet of influenza vaccine prepared in Example 1 is only an example of SLIT administration, but the dosage form application of the influenza vaccine composition is not limited to the sublingual rapidly disinte...

Embodiment 2

[0036] The impact of the kind of embodiment 2 adjuvants on the immunogenicity of influenza vaccine

[0037] The purpose of this example is to investigate the impact of the type of adjuvant on the immunogenicity of influenza vaccine, and select FimH adjuvant, MF59 adjuvant, CRX-601 adjuvant, chitosan adjuvant, and aluminum hydroxide adjuvant for comparative research.

[0038] The inspection method is as follows:

[0039] 1) Take the prescribed amount of FimH adjuvant, MF59 adjuvant, CRX-601 adjuvant, chitosan adjuvant, aluminum hydroxide adjuvant, and set aside;

[0040] 2) Fix the component ratio of the adjuvanted influenza vaccine to the tablet matrix material, refer to (Huang Jihan, Huang Xiaohui, Chen Zhiyang, et al. Equivalent dose conversion between animals and between animals and humans in pharmacological tests[J]. China Clinical Pharmacology and Therapeutics, 2004, 9 (9): 1069-1072.) article, the dosage of human sublingual tablet is converted into the dosage of mouse s...

Embodiment 3

[0048] Example 3 The impact of the type of adjuvant on sublingual mucosal immune tolerance

[0049] The purpose of this example is to investigate the impact of the type of adjuvant on sublingual mucosal immune tolerance, and select FimH adjuvant, MF59 adjuvant, CRX-601 adjuvant, chitosan adjuvant, and aluminum hydroxide adjuvant for comparative research .

[0050] The inspection method is as follows:

[0051] 1) Take the prescribed amount of FimH adjuvant, MF59 adjuvant, CRX-601 adjuvant, chitosan adjuvant, aluminum hydroxide adjuvant, and set aside;

[0052] 2) Fix the component ratio of the adjuvanted influenza vaccine and the tablet matrix material, and prepare the corresponding sublingual rapidly disintegrating tablet of influenza vaccine according to the preparation method in Example 2. Mice were inoculated with SLIT. The sublingual mucosa was isolated at 0 or 2 hours after SLIT immunization, and cells were harvested from the mucosa and analyzed by flow cytometry. Two...

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PUM

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Abstract

The invention discloses an influenza vaccine composition for sublingual mucosa delivery. The influenza vaccine composition for sublingual mucosa delivery comprises (a) an effective dose of an influenza vaccine and (b) a FimH adjuvant. According to the influenza vaccine composition for sublingual mucosa delivery, a specific content of the FimH adjuvant is selected and added into the influenza vaccine to form the composition for sublingual mucosa delivery, so that the immune response of the influenza vaccine is effectively improved, and the immune tolerance existing in sublingual mucosa delivery is avoided.

Description

technical field [0001] The invention relates to the technical field of influenza vaccine administration, in particular to an influenza vaccine composition for sublingual mucosal delivery. Background technique [0002] Influenza is an acute respiratory disease caused by influenza virus. Influenza viruses cause high mortality and morbidity worldwide due to their easy mutation, strong infectivity, and rapid transmission. To distinguish between influenza viruses, human influenza viruses are mainly type A and type B. Type A (A) is divided into several subtypes. There are three subtypes circulating in the population: A1, represented by A(H1N1); A2, represented by A(H2N2); and A3, represented by A(H3N2). The main clinical manifestations of influenza virus infection are fever, headache, general weakness, often accompanied by respiratory symptoms such as runny nose, dry cough, sore throat, and concurrent myocarditis and pericarditis. Vaccination is currently the main measure to p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/145A61K39/39A61P31/16
CPCA61K39/12A61K39/39A61K2039/525A61K2039/542A61K2039/55516A61P31/16C12N2760/16034C12N2760/16134C12N2760/16234A61K2300/00
Inventor 廖辉张庶民周荔葆马凤森刘苗苗修雪亮徐国标王一平杨文腰吴铮
Owner LIAONING CHENGDA BIOTECH
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