16-valent streptococcus pneumoniae conjugate vaccine composition

A Streptococcus pneumoniae vaccine composition technology, applied in the field of 16-valent Streptococcus pneumoniae conjugate vaccine composition, to achieve the effect of increasing broad coverage, broad-spectrum and high-efficiency protection

Pending Publication Date: 2018-12-28
SHANGHAI RUIZHOU BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The 13-valent conjugated vaccine has an average coverage rate of 70-85% for the protection of Streptococcus pneumoniae in my country (Qin Ying et al., Interpretation of the WHO position document on Streptococcus pneumoniae vaccine in 2012, Chinese Journal of Preventive Medicine, 2014, 48(2): 85-90; Wan

Method used

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  • 16-valent streptococcus pneumoniae conjugate vaccine composition
  • 16-valent streptococcus pneumoniae conjugate vaccine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Prepare strain bank

[0022] Different serotypes of Streptococcus pneumoniae were inoculated into fresh sheep blood plates at 36°C, 5% CO 2 Culture and subculture in medium, and then amplify culture in liquid medium. After reaching a certain cell density, prepare the main generation and working generation strain banks, and store them in low-temperature refrigeration. The bacterial strain bank determines the serotype, viability, sterility, stability, etc. of Streptococcus pneumoniae through identification and identification experiments, and is suitable for research and development and large-scale production.

[0023] Fermentation and Harvesting

[0024] Take the working strains and pick the strains by streaking on the solid medium, inoculate them in 5ml of liquid medium, cultivate them at 36°C, transfer them to 500ml of culture medium, and expand them into 10L or 50L fermenters after culture. The fermentation broth is kept at pH 6.5-8.5, the air flow is controlled, and...

Embodiment 2

[0041] Fermentation and Harvesting

[0042] Take the working seeds and pick the strains by streaking on the soybean peptone solid medium, inoculate them in 5ml of liquid comprehensive medium, cultivate them at 36±2°C, transfer them to 500ml of culture medium, and then expand them to 10L of culture medium and 50L fermenter containing soybean medium. Maintain pH 7.4 with sterile sodium carbonate solution, and add appropriate amount of sterile sodium deoxycholate at the end of the logarithmic growth phase to lyse bacterial cells and release bacterial capsular polysaccharides. After lysis, cool the fermenter. The pH of the lysed broth was adjusted to about pH 6.0 with acetic acid. Lysates were clarified by continuous flow centrifugation followed by depth filtration and 0.45 μm microfiltration.

[0043] Polysaccharide purification

[0044] The purification of pneumococcal polysaccharide consists of several steps of concentration / ultrafiltration operation, column chromatography ...

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Abstract

The invention discloses a 16-valent streptococcus pneumoniae conjugate vaccine composition. The vaccine composition is obtained in a manner that streptococcus pneumoniae capsular polysaccharide afterseparation and purification and carrier protein are subjected to coupling combination to be mixed, wherein the capsular polysaccharide includes 16 streptococcus pneumoniae serotypes of 1, 2, 3, 4, 5,6A, 6B, 7F, 9V, 11A, 14, 15B, 18C, 19A, 19F and 23F. The 16-valent streptococcus pneumoniae conjugate vaccine composition can cover most of common pathogenic bacterial types or drug-resistance bacterial types of our country, and has the broad-spectrum and efficient protection effect on high-risk susceptible populations such as new-born infants, old people and children under two years old.

Description

technical field [0001] The invention belongs to the field of pneumonia vaccines, and more specifically relates to a 16-valent Streptococcus pneumoniae conjugate vaccine composition. Background technique [0002] The disease caused by Streptococcus pneumoniae is the most important cause of morbidity and mortality among children in the world, especially in developing countries. The disease caused by Streptococcus pneumoniae infection has become a serious public health problem in the world. Streptococcus pneumoniae high-risk susceptible groups mainly come from newborn babies, children under 5 years old, elderly people over 65 years old and people with weakened immunity. According to the World Health Organization (WTO), in 2005, 1.6 million people died of pneumococcal disease, including 700,000 to 1,000,000 children under the age of 5, most of whom were children in developing countries (http: / / www.who. int / biologicals / areas / vaccines / pneumo / en / ). In addition, people with season...

Claims

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Application Information

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IPC IPC(8): A61K39/09A61K39/385A61K39/116A61P31/04
CPCA61K39/092A61K39/385A61K2039/6037A61K2039/70
Inventor 祝先潮陈春光张泓何平张舒林
Owner SHANGHAI RUIZHOU BIOTECH CO LTD
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