Preparation combination of multivalence pneumococcal conjugate vaccine and application thereof

A pneumococcal and conjugated vaccine technology, used in multivalent vaccines, vaccines, medical preparations containing active ingredients, etc., can solve the problems of no GSK development and increased antigen content.

Active Publication Date: 2018-09-14
CANSINO BIOLOGICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, compared with the 7-valent pneumonia conjugate vaccine, the antigen content in the finished preparation of the 13-valent pneumonia conjugate vaccine increased by 10%.
GSK’s 10-valent pneumonia

Method used

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  • Preparation combination of multivalence pneumococcal conjugate vaccine and application thereof
  • Preparation combination of multivalence pneumococcal conjugate vaccine and application thereof
  • Preparation combination of multivalence pneumococcal conjugate vaccine and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0079] 1. Differences in molecular weight of conjugates prepared with different carrier proteins

[0080] Select pneumonia capsular polysaccharides of different serotypes and couple them with CRM197 and TT respectively. The coupling method of polysaccharides and proteins adopts the commonly used experimental method in the industry—CDAP or reducing amine conjugation chemical reaction (see patent WO95 / 08348 for details ), the molecular weight of the conjugate was detected after purification, and the results are shown in Table 1.

[0081] Table 1 Molecular weight of different carrier conjugates

[0082]

[0083]

[0084] Remarks: The molecular weight of the conjugate is represented by the recovery rate of KD<0.35

[0085] The results showed that the molecular weights of the conjugates of different carrier proteins were different for the same serotype, and generally the molecular weight of TT as carrier protein was higher than that of CRM197 as carrier protein. The molecul...

Embodiment 2

[0102] 1. Immunogenicity of different carrier 13-valent pneumonia conjugate vaccines

[0103] The experimental method of capsular polysaccharide and carrier protein coupling is the same as in Example 1, prepares 13-valent pneumococcal conjugates (Table 6) of different carriers, and measures the immunogenicity in the mouse model (see Figure 5 ).

[0104] Table 6 Summary of carrier protein information for 13-valent conjugates

[0105]

[0106]

[0107] Note: All samples have the same polysaccharide antigen content of the same serotype

[0108] From Figure 5 It can be seen that the immunogenicity of some serotypes has little correlation with the carrier protein, such as SP1, 3, and 18C, but the immunogenicity of some serotypes has a great correlation with the carrier protein. On the whole, the immunogenicity of samples 4 and 5 is better than that of samples 1-3.

[0109] In short, the use of dual-carrier conjugate vaccines reduces the immune interference between diffe...

Embodiment 3

[0118] 1. Comparison of the immunogenicity of the new 13-valent pneumonia conjugate vaccine

[0119] The experimental method of capsular polysaccharide and carrier protein coupling is the same as that of Example 1, and different quantities of dual-carrier conjugate vaccines are prepared. All pneumonia serotypes are divided into two categories, one with CRM197 as the carrier protein, and the other with TT / HID as the carrier protein, choose one of them (SP7F or SP19F), two (SP7F and SP19F) , and all (SP1, SP4, SP5, SP19F, SP7F) coupled with TT or HID, the sample information is shown in Table 8, and the immune mice were studied for immunogenicity (see Figure 7 ).

[0120] Table 8 New 13-valent conjugate vaccine

[0121]

[0122] Remarks: All samples have the same polysaccharide antigen content of the same serotype, and the classification of samples coupled with HID carrier protein is the same as TT

[0123] From Figure 7It can be seen that the immunogenicity of sample 5 ...

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Abstract

The invention provides a preparation combination of multivalence pneumococcal conjugate vaccine, a preparation method thereof and application in medicine preparation for preventing and treating diseases caused by pneumococcus. The invention further discloses a control method for conjugate molecular weight in the preparation combination of the multivalence pneumococcal conjugate vaccine. The seruminhibition problem in the multivalence pneumococcal conjugate vaccine is solved by the provided pneumococcal conjugate vaccine, and the immunogenicity in the preparation combination can be effectivelyimproved. The preparation method for the preparation combination of the multivalence pneumococcal conjugate vaccine can effectively control the molecular weight in the conjugate, and free protein andfree polysaccharide which do not join in conjugation can be easily removed.

Description

technical field [0001] The invention relates to the technical field of vaccine product development, in particular to a preparation combination of a multivalent pneumococcal conjugate vaccine and a preparation method thereof, and the application of the preparation combination in preparing medicines for preventing or treating diseases caused by pneumococcus. Background technique [0002] Streptococcus pneumoniae, referred to as pneumococcus for short, is a Gram-positive bacterium whose main pathogenic factor is capsular polysaccharide. Capsulated strains are 10 times more virulent than non-encapsulated strains 5 times. According to the antigenic structure of the capsular polysaccharide, pneumococcus is divided into more than 90 serotypes, of which about 30 serotype strains can cause a variety of invasive diseases, including bacteremia, meningitis, pneumococcal pneumonia, and invasive pneumonia Coccidiosis (IPD) etc. [0003] Pneumococcus mainly causes lobar pneumonia, which...

Claims

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Application Information

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IPC IPC(8): A61K39/116A61K39/385A61K39/09A61P31/04
CPCA61K39/092A61K39/385A61K2039/6037A61K2039/70A61P31/04
Inventor 李军强巢守柏朱涛莘春林
Owner CANSINO BIOLOGICS INC
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