15-valence pneumococcus conjugate combined vaccine containing 2-type and 12 F serotypes

A pneumococcal and combined vaccine technology, applied in the direction of multivalent vaccines, vaccines, antibacterial drugs, etc., can solve the problems of high lethality and non-inclusion

Pending Publication Date: 2016-10-12
BEIJING ZHIFEI LVZHU BIOPHARM +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In Guatemala, type 2 is the most lethal form of invasive pneumococcal disease in children, causes most meningitis, occurs at a young age (average 3.5 months), but is not covered by existing pneumococcal conjugate vaccines (Gaensbauer JT, et al al.Pediatric Invasive Pneumococcal Disease inGuatemala City:Importance of Serotype 2.Pediatr Infect Dis J.2016May;35(5):e139-43.)

Method used

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  • 15-valence pneumococcus conjugate combined vaccine containing 2-type and 12 F serotypes
  • 15-valence pneumococcus conjugate combined vaccine containing 2-type and 12 F serotypes
  • 15-valence pneumococcus conjugate combined vaccine containing 2-type and 12 F serotypes

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1: 15-valent pneumococcal conjugate combination prescription

[0037] Each 0.5ml dose contains a total of 32 μg of various types of polysaccharides (total polysaccharides), including 4 μg of type 6B, 2 μg each of type 1, 2, 3, 4, 5, 6A, 7F, 9V, 12F, 14, 18C, 19A, 19F, and 23F . Various types of polysaccharides are combined with diphtheria toxoid and adsorbed on aluminum phosphate adjuvant (aluminum content 0.125 mg), and the solvent is physiological sodium chloride solution.

Embodiment 2

[0038] Example 2: 15-valent pneumococcal conjugates combined with different injections of antibodies after immunizing mice

[0039] NIH mice were used to subcutaneously immunize 3 injections, each injection was separated by 2 weeks, and the dose was 0.1ml. Blood was collected 14 days after each dose of immunization, serum was separated, and the specific serum titer was determined. The serum antibody titer was determined by taking the mean value of the negative control plus 2 times SD as the cutoff value, and the data was analyzed after taking the logarithm, and the seroconversion rate was evaluated by the increase of the antibody by more than 4 times. The results show that the conjugate combination of the present invention can induce high-titer specific antibodies in mice, and ideal antibody titers and seroconversion rates can be achieved with one shot of immunization. For mice with very high antibody titers, again Antibody titers after immunization no longer increased.

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Embodiment 3

[0042] Example 3: 15-valent pneumococcal conjugate combination guinea pig active allergy test

[0043] Divided into two immunization dose groups of 2ml and 0.5ml, healthy white guinea pigs were intraperitoneally injected with 15-valent pneumococcal combination combination, once every other day, for sensitization for 3 consecutive times; on the 12th day after the last sensitization, a single intravenous injection was used to sensitize twice The combination of 15-valent pneumococcal conjugates of the dose was used for stimulation, and the allergic reaction of the 2ml dose group to guinea pigs was positive (++3, +++2, ++++1), and the main symptoms were restlessness, piloerection, Trembling, nose scratching, sneezing, coughing, shortness of breath, urination, tearing, dyspnea, unsteady gait, convulsions, death, the reaction appeared about 1 minute after administration, and death appeared about 5 minutes after administration, the surviving mice The reaction disappeared within half ...

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PUM

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Abstract

The invention relates to a 15-valence pneumococcus conjugate combined vaccine. The combination particularly contains 2-type and 12 F serotypes, has a wide immunization coverage rate and is used for preventing infectious diseases caused by pneumococcus. The combined vaccine further contains a 1-type serotype, a 3-type serotype, a 4-type serotype, a 5-type serotype, a 6A serotype, a 6B serotype, a 7F serotype, a 9V serotype, a 14-type serotype, a 18 C serotype, a 19 A serotype, a 19 F serotype and a 23 F serotype.

Description

Technical field: [0001] The invention relates to a 15-valent pneumococcal conjugate combination vaccine, which particularly contains type 2 and 12F serotypes, has wide immune coverage, and is used for preventing infectious diseases caused by Streptococcus pneumoniae. Background technique: [0002] Streptococcus pneumoniae is the most important pathogen causing community acquired pneumonia (CAP) in all age groups in developing and developed countries, and also the main pathogen causing otitis media, pneumonia, meningitis and bacteremia. Worldwide, the annual death toll caused by Streptococcus pneumoniae infection accounts for 9% of the total death toll, more than 30,000 cases of meningitis, more than 630,000 cases of bacteremia, 14 million cases of otitis media, and pneumonia caused by Streptococcus pneumoniae. 20 million cases. [0003] The immune preparations for preventing pneumococcal infection are divided into two types: polysaccharide vaccine and conjugate vaccine. pn...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/116A61K39/09A61P31/04
CPCA61K39/09A61K2039/55505A61K2039/55544A61K2039/55566A61K2039/55572A61K2039/55577A61K2039/55594A61K2039/6037A61K2039/6068A61K2039/70
Inventor 杜琳蒋仁生
Owner BEIJING ZHIFEI LVZHU BIOPHARM
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