Multivalent DTP-POLID vaccines

An immune composition and technology for polio, applied in the field of multivalent vaccine administered in pediatrics, can solve the problem of immunogenicity reduction and other problems

Inactive Publication Date: 2008-08-06
CONNAUGHT LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, reduced immunogenicity has been reported for acellular pertussis vaccines containing PT, FHA, and 69K (Ref. 77) and for acellular pertussis vaccines containing PT, FHA, and 69K, and pili (Ref. 76).

Method used

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  • Multivalent DTP-POLID vaccines
  • Multivalent DTP-POLID vaccines
  • Multivalent DTP-POLID vaccines

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0072] Agglutinogen preparation

[0073] Referring to Fig. 1, this is a flowchart illustrating a method for preparing an agglutinogen from a Bordetia strain. As shown in Figure 1, a Bordetella cell homogenate containing an agglutinogen, such as a Bordetella pertussis cell homogenate, is extracted with, for example, a urea-containing buffer, such as selection with 10 mM potassium phosphate, 150 mM NaCl and 4M urea. The agglutinogen was selectively extracted from the cell homogenate to obtain the first supernatant (sp1) containing the agglutinogen and the first residual precipitate (ppt1). The first supernatant (sp1) can be separated from the first residual precipitate (ppt1) by eg centrifugation. This residual precipitate (ppt1) was discarded. The clarified supernatant (sp1) can then be concentrated and diafiltered eg 10 mM potassium phosphate / 150 mM NaCl / 0.1% Triton X-100 using eg a 100-300 kDa NMWL filter.

[0074] The first supernatant is then incubated at a certain tempe...

Embodiment 1

[0223] This example will describe the cultivation of Bordetella pertussis.

[0224] Main strain:

[0225] The culture of the main strain of Bordetella pertussis is stored at 2°C-8°C in the form of batch freeze-dried strains.

[0226] Working strains:

[0227] This freeze-dried culture was revived in Hornibrook medium and used to plate on Bordet-Gengou agar (BGA) plates. Hornibrook medium contains the following components:

[0228] Composition 1 Litre

[0229] Casein hydrolyzate (activated carbon treatment) 10.0g

[0230] Niacin 0.001g

[0231] CaCl 2 0.002g

[0232] NaCl 5.0g

[0233] MgCl 2 ·6H 2 O 0.025g

[0234] KCl0.200g

[0235] K 2 HPO 4 0.250g

[0236] Starch 1.0g

[0237] distilled water to 1.0 liter

[0238] Adjust the pH to 6.9 ± 0.1 with 1% sodium carbonate. This medium was dispensed into test tubes and sterilized: steam heated in an autoclave for 20 minutes, then autoclaved at 121°C-124°C for 20 minu...

Embodiment 2

[0267] This example describes the purification of antigens from Bordetella pertussis cell cultures.

[0268] Prepare media and cell concentrates:

[0269] In two production fermenters, the bacterial suspension was incubated at 34°C-37°C for 35-50 hours. Take samples from the fermenter and check that there are no bacteria in the culture medium. This suspension was added to a continuous flow disc-pack centrifuge and centrifuged (12000 xg) to separate the cells from the culture medium. Cells are collected and ready for extraction of pili components. The supernatant was passed through a ≤0.22 μm filter membrane, and the filtrate was concentrated by ultrafiltration with a 10-30 kDa nominal molecular weight limit (NMWL) membrane. Store this concentrate, waiting for the separation and purification of pertussis toxin (PT), filamentous hemagglutinin and 69kDa (Pertactin) and other components.

[0270] Separate the components in the culture medium:

[0271] The components (69 kDa, ...

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Abstract

A multi-component vaccine composition is described comprising acellular pertussis vaccine components, diphtheria toxoid, tetanus toxoid and inactivated poliovirus. The composition also may contain a conjugate of a capsular polysaccharide of Haemophilus influenzae type b and tetanus toxoid or diphteria toxoid, which may be reconstituted from a lyophilized state by the other components of the vaccine. The administration of the multiple component vaccine results in no diminution in the immunogenicity of any component as a result of interference by other components of the vaccine.

Description

field of invention [0001] The present invention relates to multivalent vaccines, in particular multivalent vaccines for pediatric administration. [0002] Referenced related applications [0003] This application is a continuation-in-part of co-pending U.S. Patent Application No. 08 / 501,743 filed July 12, 1995, which itself is a co-pending U.S. Patent Application No. filed May 4, 1995. Part of 08 / 433,646 continued application. Background of the invention [0004] Pertussis is a severe, highly contagious upper respiratory tract infection caused by the bacterium Bordetella pertussis (B. pertussis). The World Health Organization estimates that there are 60 million cases of pertussis each year, resulting in 500,000 to 1 million deaths (Ref. 1. Throughout this specification, various references are given in parentheses in order to fully understand Discusses the state of the art to which the present invention pertains. The complete bibliographic information of each reference can...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/295A61P31/04A61K31/00A61K39/05A61K39/08A61K39/10A61K39/102A61K39/116A61K39/13A61P31/00A61P31/12
CPCA61K39/295A61K39/0016A61K39/12A61K2039/70C12N2760/16234C12N2770/32634A61K39/05A61K39/08A61K39/099A61K39/102A61K2039/5252A61K2039/55A61K2039/55505A61P11/00A61P31/00A61P31/04A61P31/12A61P31/14A61P31/16A61P37/04Y02A50/30
Inventor R·E·F·法希姆L·U·L·潭L·巴雷托J·蒂普哈旺G·E·D·杰克森
Owner CONNAUGHT LAB
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