Liquid vacuum composition and application thereof

A liquid vaccine and composition technology, applied in the field of vaccines, can solve the problems of rebound of pertussis incidence, cumbersome reconstitution process, drop in vaccination rate, etc., so as to avoid wrong or missed vaccination, avoid reconstitution process, and reduce workload. Effect

Active Publication Date: 2020-03-27
SINOVAC RES & DEV
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the 1970s, due to serious adverse reactions after inoculation with whole-cell diphtheria pertussis vaccine (DTwP), countries such as Japan and the Netherlands appeared to resist vaccination and stop using it, resulting in a decline in the vaccination rate, resulting in the incidence of pertussis There is a rebound
Although there are similar products (DTaP / Hib / Men) in development both at home and abroad at present, its Hib and Men components still adopt freeze-drying process to prepare corresponding combined vaccines; Reconstitution, the reconstitution process is cumbersome; at the same time, based on the safety risk introduced by the freeze-drying process and the limitation of production capacity, the adsorption of acellular diphtheria-poliovirus inactivated vaccine-Haemophilus influenzae type b (combined)- Research on meningococcal polysaccharide (conjugated) liquid combination vaccine, which has good social and economic value

Method used

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  • Liquid vacuum composition and application thereof
  • Liquid vacuum composition and application thereof
  • Liquid vacuum composition and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] This embodiment provides a liquid vaccine preparation, which contains the following components per person-time dosage:

[0047] Pertussis toxin 8μg, filamentous hemagglutinin 8μg, pertactin 2.5μg, diphtheria toxoid 2Lf, tetanus toxoid 5Lf, inactivated poliovirus type I stock solution 7.5DU, inactivated poliovirus type II Virus stock solution 22.5DU, inactivated type III poliovirus stock solution 22.5DU, group A meningitis polysaccharide-protein conjugate 10 μg, group C meningitis polysaccharide-protein conjugate 10 μg, Haemophilus influenzae type b polysaccharide-protein conjugate 10μg, aluminum content 0.6mg / ml, appropriate amount of sodium chloride aqueous solution, and phosphate buffer solution to adjust the pH value to 5.8-7.2. An appropriate amount of stabilizers, such as M199 medium and amino acids, can also be added to the vaccine.

[0048] Mix the combined vaccine well before use for intramuscular injection.

[0049] The liquid vaccine formulation provided in ...

Embodiment 2

[0051] This embodiment provides a liquid vaccine preparation, which contains the following components per person-time dosage:

[0052] Pertussis toxin 8 μg, filamentous hemagglutinin 8 μg, pertactin 2.5 μg, diphtheria toxoid 2Lf, tetanus toxoid 5Lf, inactivated poliovirus type I stock solution 15DU, inactivated poliovirus type II Stock solution 45DU, inactivated type III poliovirus stock solution 45DU, group A meningitis polysaccharide-protein conjugate 15 μg, group C meningitis polysaccharide-protein conjugate 15 μg, Haemophilus influenzae type b polysaccharide-protein conjugate 15 μg, The aluminum content is 0.8 mg / ml, an appropriate amount of sodium chloride aqueous solution, and a phosphate buffer solution to adjust the pH value to 5.8-7.2. An appropriate amount of stabilizers, such as M199 medium and amino acids, can also be added to the vaccine.

[0053] Mix the combined vaccine well before use for intramuscular injection.

[0054] The liquid vaccine formulation provid...

Embodiment 3

[0056] This embodiment provides a liquid vaccine preparation, which contains the following components per person-time dosage:

[0057] Pertussis toxin 25μg, filamentous hemagglutinin 25μg, pertactin 8μg, diphtheria toxoid 12.5Lf, tetanus toxoid 3.5Lf, inactivated poliovirus type I stock solution 15DU, inactivated poliovirus type II Virus stock solution 45DU, inactivated type III poliovirus stock solution 45DU, group A meningitis polysaccharide-protein conjugate 10 μg, group C meningitis polysaccharide-protein conjugate 10 μg, Haemophilus influenzae type b polysaccharide-protein conjugate 10 μg , aluminum content 0.8mg / ml, appropriate amount of sodium chloride aqueous solution, and phosphate buffer solution to adjust the pH value to 5.8-7.2. An appropriate amount of stabilizers, such as M199 medium and amino acids, can also be added to the vaccine.

[0058] Mix the combined vaccine well before use for intramuscular injection.

[0059] The liquid vaccine preparation provided in ...

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Abstract

The invention relates to a liquid vacuum composition which comprises diphtheria toxoid, tetanus toxoid, pertussis toxins, filamentous hemagglutinin, pertactin, inactivated poliovirus, type-b haemophilus influenzae capsular polysaccharide-protein conjugate and meningococcus capsular polysaccharide-protein conjugate, wherein the inactivated poliovirus comprises type-I, type-II and type-III poliovirus Sabin strains. By adopting the liquid vacuum composition provided by the invention, security risks caused by freeze-drying processes and limits of production capacities can be avoided, and meanwhile, a tedious redissolution process needed before immunization of a freeze-dried vacuum is avoided. The liquid vacuum composition provided by the invention is capable of preventing six infectious diseases simultaneously, so that the workload of inoculation and the burden of children can be greatly reduced.

Description

technical field [0001] The invention relates to the field of vaccines, in particular to a liquid vaccine composition capable of simultaneously preventing pertussis, diphtheria, tetanus, polio, Haemophilus influenzae type b and Neisseria meningitidis. Background technique [0002] Timely vaccination is an effective preventive and protective measure. Pertussis, diphtheria and tetanus combined vaccine (DTP), as the first vaccine included in the WHO Expanded Immunization Program (EPI), has played an important role in the prevention and control of these three infectious diseases. In the 1970s, due to serious adverse reactions after inoculation with whole-cell diphtheria pertussis vaccine (DTwP), countries such as Japan and the Netherlands appeared to resist vaccination and stop using it, resulting in a decline in the vaccination rate and the incidence of pertussis There is a backlash. At present, in most developed countries, acellular diphtheria pertussis vaccine (DTaP) with le...

Claims

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Application Information

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IPC IPC(8): A61K39/295A61K39/02A61K39/05A61K39/08A61K39/095A61K39/102A61K39/12A61P31/04A61P31/14
CPCA61K39/099A61K39/05A61K39/08A61K39/102A61K39/095A61K39/12A61P31/04A61P31/14A61K2039/70C12N2770/32034Y02A50/30
Inventor 范鑫韩振隋晓斌徐树利王治伟杨帆高强尹卫东
Owner SINOVAC RES & DEV
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