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Vaccine

A vaccine and combined vaccine technology, applied in the field of vaccines for poliomyelitis prevention, can solve the problems of complicating the development of multi-component vaccines

Inactive Publication Date: 2009-09-16
GLAXOSMITHKLINE BIOLOGICALS SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Multi-component vaccine development is complicated by the well-documented phenomenon of antigenic competition (or interference)

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0205] Example 1: Testing of Low Dose IPV Formulations

[0206] For all formulations of Example 1, except IPV (which was added but not adsorbed), the antigen was adsorbed by addition of aluminum salts prior to preparation.

[0207] The table below shows the adsorption methods for D, T, Pw and HBsAg.

[0208] AlPO 4

[0209] |

[0210] D (7.5Lf / 0.075mg Al 3+ )

[0211] |

[0212] Stir at room temperature for 15 to 20 minutes.

[0213] |

[0214] Adjust pH to pH5.1+ / -0.1

[0215] |

[0216] Stir at room temperature for 15 to 20 minutes.

[0217] |

[0218] Calibration pH5.1+ / -0.1

[0219] |

[0220] Stir at room temperature for 15 up to 45 minutes.

[0221] |

[0222] Mature at 37°C + / -1°C for 7 days + / - 8 hours without stirring (glass con...

Embodiment 2

[0374] Example 2: Feasibility of not using thimerosal in the vaccine of the present invention

[0375] The Preservative Efficiency Test (PET) enables the detection of antimicrobial activity of test vaccines. The test includes:

[0376] In the final container step of the vaccine formulation, the vaccine formulation is challenged with a designated inoculation of suitable microorganisms,

[0377] Store the inoculated formulation at the indicated temperature

[0378] Samples are withdrawn from the container at regular intervals and the organisms in the withdrawn samples are counted.

[0379] PET assay procedures are described in the European Pharmacopoeia (5.1.3) and USP (). According to these guidelines, antimicrobial activity was evaluated by comparing the reduction in the number of viable microorganisms with the criteria mentioned in the table below (Table 7)

[0380]

[0381] Table 7. EP and USP Standards

[0382] Nru * : not recycled

[0383] Ni * : not increased ...

Embodiment 3

[0384] Example 3: Effect of Hib components on IPV potency and IPV stability over time

[0385] The relative potency of IPV was tested as described in Example 1 to determine the effect of the Hib component on IPV potency and to evaluate the stability of IPV over time under different IPV dose conditions. The vaccines studied were DTPwHBIPV(40-8-32) with reconstituted DTPwHBIPV and stored for 8 months, DTPwHBIPV(20-4-16), with reconstituted DTPwHBIPV (20-4-16) and stored for 8 months , DTPwHBIPV (20-4-16) and stored for 8 months, DTPwHBIPV (10-2-8) and DTPwHBIPV (10-2-8) containing reconstituted Hib and stored for 8 months. Measured relative to DTPaIPVHB (Pediarix) ( image 3 a) or Poliorix ( image 3 b) RP value. The Hib component was found to have no effect on IPV potency. The relative potency of IPV was found to be maintained at month 8 ( image 3 ).

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Abstract

The present invention relates to the field of vaccines for protecting against polio, and in particular to combination vaccines for protecting against polio, diphtheria, tetanus, and pertussis diseases. Specifically, vaccines comprising reduced dose inactivated poliovirus (IPV) is provided, which can maintain an adequate or improved level of protection against polio.

Description

field of invention [0001] The invention relates to the field of vaccines for preventing polio, in particular to a combined vaccine for preventing polio, diphtheria, tetanus and pertussis. Background technique [0002] Combination vaccines, which provide protection against multiple pathogens, are highly desirable in order to minimize the number of immunizations required to confer protection against multiple pathogens, reduce the cost of administration, and increase acceptance and coverage. The development of multicomponent vaccines is complicated by the well-documented phenomenon of antigenic competition (or interference). Antigen interference refers to the observation that administration of multiple antigens often results in a reduced response to certain antigens relative to the response when those antigens are administered alone. [0003] Combination vaccines are known to protect against Bordetella pertussis, Clostridium tetani, Corynebacterium diphtheriae, and optionally ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/13
CPCY02A50/30
Inventor H·德亨普丁纳M·迪谢纳A·玛丽M·索恩沃
Owner GLAXOSMITHKLINE BIOLOGICALS SA
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