Recombinant human papillomavirus vaccine composition and use thereof

A technology of human papillomavirus and composition, which is applied in the field of recombinant human papillomavirus vaccine composition, can solve the problems of low vaccination completion rate, achieve the effects of reducing antigen immunization dose, high immune activity, and reducing the number of immunizations

Active Publication Date: 2022-02-08
IMMUNE PATH BIOTECHNOLOGY SUZHOU CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Although some HPV preventive vaccines have been developed in the world's existing technologies, there are still problems such as low vaccination completion rate due to more immunization shots

Method used

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  • Recombinant human papillomavirus vaccine composition and use thereof
  • Recombinant human papillomavirus vaccine composition and use thereof
  • Recombinant human papillomavirus vaccine composition and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1: the preparation of the vaccine composition containing HPV each type L1 VLP antigenic protein

[0044] In order to study the technical effect of the vaccine preparation composition provided by the present invention. The inventors of the present invention have made the following various vaccine preparation compositions (0.5ml / dose), each preparation composition contains HPV various types of L1 VLP proteins (HPV16L1, 18L1, 6L1, 11L1, 31L1, 33L1, 45L1, 52L1, 58L1), aluminum adjuvant and CpG ODN adjuvant. The specific preparation method is as follows: Firstly, the stock solution of various types of HPV L1 VLP antigens is adsorbed on aluminum adjuvant (aluminum phosphate adjuvant AP, purchased from Zerun Biotechnology Co., Ltd.), and prepared into different ratios of various types of HPV L1 VLP antigens / aluminum Adjuvant (w / w) ratio of the adsorbed sample (here the aluminum adjuvant content is substantially the content of aluminum element); then add different c...

Embodiment 2

[0049] For obtaining the recombinant human papillomavirus vaccine preparation composition to be evaluated in Example 1. The inventors carried out immunogenicity studies using BALB / c mice as animal models. The immunogenicity of the vaccine preparation composition provided by the present invention was studied with various types of HPV L1 VLP proteins as antigens and aluminum adjuvant and CpG ODN as adjuvants. Select BALB / female mice aged 6-8 weeks and divide them into random groups, 10 mice in each group, intramuscularly inject vaccines prepared with HPV L1 VLP proteins of various types combined with adjuvant (Table 1), and the injection volume is 0.05ml (that is, 1 / 10 doses), set up a self-made vaccine group, a marketed vaccine Gardsail 9 group, and an adjuvant control group. One injection group was immunized on day 0, and blood was collected on day 35; Groups were immunized on days 0, 21, and 42, and blood was collected on day 56. Pseudovirion-Based Neutralization Assay (PB...

Embodiment 3

[0077] The inventors also studied the immunogenicity of new nine-valent HPV vaccines with different CpG ODN contents (such as 500~1000μg), and the immunogenicity of new nine-valent HPV vaccines containing different CpG ODN types (such as CpG7909 and CpG1018), and the results It shows that the new nine-valent HPV vaccines with various formulations have good immunogenicity. The mouse experiment procedure and neutralizing antibody detection method are the same as in Example 2, and the research results are shown in Table 6 below.

[0078] Table 6 GMT of mouse serum neutralizing antibody titers 14 days after two injections of each vaccine

[0079]

[0080] Note: See Table 1 for the formulations of No. 2, 4, 6 and 7 vaccines. The doses for mouse muscle immunization are all 1 / 10 doses, and the volume of immunization is 0.05ml.

[0081] It can be seen from Table 2-6 that the vaccine composition prepared according to the specific components and ratios provided by the present invent...

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Abstract

The invention discloses a recombinant human papillomavirus vaccine composition and its application. Compared with the combination of other antigens and adjuvants, the novel vaccine composition provided by the present invention has more beneficial immune effects, reduces the number of immunizations, reduces the dose of antigen immunization, reduces immunization costs, and is beneficial to improve the immunization coverage. Therefore, the vaccine composition of the present invention becomes a new generation of human papillomavirus vaccine.

Description

technical field [0001] The invention belongs to the field of biomedicine, in particular, the invention relates to a recombinant human papillomavirus vaccine composition and application. Background technique [0002] Papillomavirus (PV) is a pathogen that can infect vertebrates, and more than 300 species have been discovered so far. There are more than 200 types of human papillomavirus (HPV) that can infect humans, and more than 40 of them can cause human diseases. The capsid of HPV is composed of major capsid protein L1 and minor capsid protein L2. HPV mainly infects skin and mucous membrane tissues, and in most cases HPV infection has no obvious clinical symptoms. However, some persistent HPV infections can cause skin and mucous membrane epithelial hyperplasia and even canceration. Clinically, it is manifested as different types of epithelial warts, malignant tumors such as cervical cancer, anal cancer and vaginal cancer. According to the relationship with cancer, these...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/295A61K39/12A61K39/39A61P31/20
CPCA61K39/12A61K39/39A61P31/20A61K2039/55505A61K2039/55561C12N2710/20034A61K2039/523A61K2039/70A61K2039/5258A61K2039/545C12N2710/20023C12N2710/20071C07K14/005C12N7/00
Inventor 周晨亮李军瑞宋玉娇魏健刘革史力莫呈钧张智
Owner IMMUNE PATH BIOTECHNOLOGY SUZHOU CO LTD
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