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Adsorbed DTaP-IPV/Hib combined vaccine and preparation method thereof

A technology for Haemophilus influenzae and cell-free DTP, which is applied in the fields of medical biotechnology and biological products, can solve problems such as strong toxicity, and achieve the effects of low production cost, optimized composition and content, and less adverse reactions to vaccines

Active Publication Date: 2019-04-02
BEIJING MINHAI BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, only Pentaxim TM produced by SanofiPasteur (SP) is the only DTaP-IPV / Hib combination vaccine approved for marketing in China. Strong toxicity, therefore, the World Health Organization (WHO) encourages more manufacturers to use the Sabin strain to produce inactivated polio vaccine (sIPV)

Method used

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  • Adsorbed DTaP-IPV/Hib combined vaccine and preparation method thereof
  • Adsorbed DTaP-IPV/Hib combined vaccine and preparation method thereof
  • Adsorbed DTaP-IPV/Hib combined vaccine and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0054] The IPV neutralizing antibody level analysis of the combined vaccine of embodiment 1 different Sabin strain antigen content

[0055] In order to analyze the influence of different Sabin strain antigen content on the IPV immune effect of combined vaccine, prepare three kinds of DTaP-IPV / Hib combined vaccine test articles (test articles 1, 2) containing different concentrations of I, II, and III type D antigens. , 3), the antigenic content of three kinds of combination vaccines for testing is as shown in table 1, is reference substance with commercially available IPV vaccine. Wistar rats were immunized with three kinds of test products and control products, 10 rats in each group, each rat was injected with 0.5 mL, blood was collected 21 days after immunization to separate serum, and the titer of poliomyelitis neutralizing antibody in rats was detected by cell method, calculated ED50 value.

[0056] Table 1 Antigen content of three kinds of combination vaccines for testin...

Embodiment 2

[0065] Embodiment 2 Contains the protective effect analysis of the DTaP-IPV / Hib combination vaccine of different concentrations of aluminum hydroxide

[0066] On the basis of the test product 1 in Example 1, the adjuvant of the DTaP-IPV / Hib combination vaccine was optimized, and the DTaP-IPV / Hib combination vaccine containing different concentrations of aluminum hydroxide adjuvant was prepared respectively, wherein each 0.5mL The aluminum hydroxide content in the preparation is respectively 0.5mg / mL, 1.0mg / mL, 1.5mg / mL, 2.0mg / mL and 2.5mg / mL, carry out pertussis, diphtheria, tetanus potency, Hib antibody test respectively. The conversion rate and the in vivo immune efficacy experiment of IPV were used to analyze the immune effect of the combined vaccine. The diphtheria, tetanus, pertussis and Hib potency tests were carried out according to the third part of the "Chinese Pharmacopoeia" 2015 edition. IPV was used to immunize wistar rats with 4 dilutions of original times, 1 / 3 t...

Embodiment 3

[0078] The effect of embodiment 3 phosphate buffer saline on the antigenic protein adsorption rate and pH stability of DTaP-IPV / Hib combination vaccine

[0079] On the basis of the DTaP-IPV / Hib combined vaccine that the test product 1 of Example 1 contains 1.5mg / mL aluminum hydroxide adjuvant, investigate adding 2mmol, 4mmol, 6mmol, 8mmol, 10mmol sodium dihydrogen phosphate-disodium hydrogen phosphate phosphate buffer (pH 6.0-7.0), the influence of aluminum hydroxide adjuvant on antigenic protein adsorption rate and pH stability. The protein adsorption rate analysis is shown in Table 10. After adding phosphate buffer, the protein adsorption rate decreased gradually with the increase of the concentration of phosphate buffer. When the concentration of phosphate buffer was 8mmol / mL, the protein adsorption rate dropped to below 90%. When the concentration is 2-6mmol / mL, the adsorption rate is above 90%, so the concentration of the phosphate buffer in the combined vaccine should n...

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Abstract

The invention discloses an adsorbed DTaP-IPV / Hib combined vaccine and a preparation method thereof. The combination vaccine provided by the present invention includes an acellear pertussis antigen, adiphtheria antigen, a tetanus antigen, inactivated poliovirus and a haemophilus influenzae type b antigen, wherein the poliovirus is a Sabin strain. The method adopts the attenuated strain of the poliovirus Sabin strain to prepare the combined vaccine, and the combined vaccine has higher biosafety, less adverse reaction, and low production cost. By optimizing the antigen composition, adjuvants andstabilizers of the combined vaccine, the immunogenicity of various antigens in the combined vaccine provided by the invention are fully exerted, and the combined vaccine has high stability, and is suitable for popularization and application.

Description

technical field [0001] The invention relates to the fields of medical biotechnology and biological products, in particular to an adsorption-free DTP-poliomyelitis-Hemophilus influenzae type b combined vaccine and a preparation method thereof. Background technique [0002] Whooping cough, diphtheria, tetanus, poliomyelitis and Haemophilus influenzae type b (Hib) infections are all infectious diseases that seriously endanger human health, especially the health of infants and young children. Vaccination is the most cost-effective measure to prevent these infectious diseases . [0003] Since 1997, Canada and some European countries have started to use the pertussis-diphtheria-tetanus-polio-haemophilus influenzae type b (DTaP-IPV / Hib) vaccine, and more than 20 countries have now used it Listed as immunization program. DTaP-IPV / Hib combination vaccine can simultaneously prevent five serious threats to infants and young children including pertussis, diphtheria, tetanus, poliomyel...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/295A61K39/116A61K39/10A61K39/08A61K39/05A61K39/102A61K39/13A61P31/04A61P31/14
CPCA61K39/0016A61K39/102A61K39/12A61K2039/5254A61K2039/55505A61K2039/70A61P31/04A61P31/14C12N2770/32334Y02A50/30
Inventor 王婷婷庞强齐世博刘建凯郑海发
Owner BEIJING MINHAI BIOTECH
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