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Liquid vaccine composition, and preparation method and application thereof

A liquid vaccine and composition technology, applied in the field of vaccines, can solve problems such as cumbersome reconstitution process, drop in vaccination rate, and rebound of pertussis incidence, and achieve the effect of avoiding reconstitution process, reducing workload and avoiding wrong vaccination

Pending Publication Date: 2020-04-14
SINOVAC RES & DEV
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  • Summary
  • 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
[0005] Due to the differences in the distribution of epidemics and the limitation of research difficulty, the Hib component of similar products currently under development at home and abroad still adopts the freeze-drying process to prepare the corresponding combined vaccine; The redissolving 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 DPT-inactivated poliovirus vaccine-Haemophilus influenzae type b (combined) liquid combination Vaccine research has good social and economic value

Method used

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  • Liquid vaccine composition, and preparation method and application thereof
  • Liquid vaccine composition, and preparation method and application thereof
  • Liquid vaccine composition, and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] This embodiment provides a liquid vaccine preparation, which contains the following components per person-time dosage:

[0041] 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, Haemophilus influenzae type b polysaccharide-protein conjugate 10μg, aluminum content 0.6mg / ml, appropriate amount of sodium chloride aqueous solution, phosphate buffer to adjust pH Value to 5.8 ~ 7.2. An appropriate amount of stabilizers, such as M199 medium and / or amino acids, can also be added to the vaccine.

[0042] The liquid vaccine formulation provided in this example can be used for booster immunization.

Embodiment 2

[0044] This embodiment provides a liquid vaccine preparation, which contains the following components per person-time dosage:

[0045] 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 poliovirus type III stock solution 45DU, Haemophilus influenzae type b polysaccharide-protein conjugate 15μg, aluminum content 0.8mg / ml, appropriate amount of sodium chloride aqueous solution, phosphate buffer solution to adjust the pH value to 5.8 ~7.2. An appropriate amount of stabilizers, such as M199 medium and / or amino acids, can also be added to the vaccine.

[0046] The liquid vaccine formulation provided in this example can be used for booster immunization.

Embodiment 3

[0048] This embodiment provides a liquid vaccine preparation, which contains the following components per person-time dosage:

[0049] 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 poliovirus type III stock solution 45DU, Haemophilus influenzae type b polysaccharide-protein conjugate 10μg, aluminum content 0.8mg / ml, sodium chloride aqueous solution with appropriate amount of phosphate buffer to adjust the pH value to 5.8 ~7.2. An appropriate amount of stabilizers, such as M199 medium and / or amino acids, can also be added to the vaccine.

[0050] The liquid vaccine preparation provided in this example can be used for basic immunization.

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Abstract

The invention relates to a liquid vaccine composition. The liquid vaccine composition comprises diphtheria toxoid, tetanus toxoid, pertussis toxin, filamentous hemagglutinin, Bordetella pertussis adhesin, an inactivated poliovirus type I Sabin strain, an inactivated poliovirus type II Sabin strain, an inactivated poliovirus type III Sabin strain and a Haemophilus influenzae type b capsular polysaccharide-protein conjugate. The liquid vaccine composition avoids the safety risk and capacity limitation caused by a freeze-drying process, avoids the tedious redissolving process of a freeze-dried vaccine before immunization, and reduces the production and use costs. Furthermore, the vaccine composition can be used for basic immunization or enhanced immunization, and the titer of the antibody inserum of an immunized person can be improved on the basis of ensuring safety.

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 and Haemophilus influenzae type b. 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 less side effects is produ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/295A61K39/13A61K39/05A61K39/08A61K39/10A61K39/102A61K47/18A61P31/14A61P31/04
CPCA61K39/12A61K39/05A61K39/08A61K39/099A61K39/102A61K47/183A61P31/14A61P31/04A61K2039/70C12N2770/32334A61K2039/5252Y02A50/30
Inventor 王治伟范鑫徐树利隋晓斌吴慕胜李海涛高强尹卫东
Owner SINOVAC RES & DEV
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