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Multivalent glycoconjugates immunogenic compositions

A technology of immunogenicity and composition, applied in the field of polysaccharide conjugate composition, can solve the problem that there is no human NTS vaccine available

Pending Publication Date: 2021-08-17
BHARAT BIOTECH INTERNATIONAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0020] No human NTS vaccine is available, although different forms of typhoid vaccine are in use

Method used

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  • Multivalent glycoconjugates immunogenic compositions
  • Multivalent glycoconjugates immunogenic compositions
  • Multivalent glycoconjugates immunogenic compositions

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0096] Example 1: Vaccine produced

[0097] The combined ethylene glycol conjugate vaccine compositions of the present disclosure are provided in Table 1.

[0098] Table 1: Vaccines according to the invention

[0099]

[0100]

Embodiment 2

[0101] Example 2: Vaccine production method

[0102] A. Preparation of Salmonella enteritidis COPS:FliC conjugate:

[0103] Conjugation of S. Enteritidis COPS to S. Enteritidis FliC was achieved by cyanylation chemistry to generate lattice conjugates on the protein with more than one random primary amine and Hydrazide crosslinking. For this, the protein is first derivatized at the carboxyl group of the protein with adipate dihydrazide using carbodiimide. Additionally, COPS was activated with CDAP to introduce reactive cyanate groups at the polysaccharide hydroxyl groups. The derivatized protein and activated polysaccharide are then mixed together because the protein and polysaccharide are linked to each other at more than one point; this forms a heterogeneous lattice that differs both in molecular weight and distribution of attachment points. Figure 1 shows an overview of the chemical synthesis of the S. Enteritidis COPS:FliC conjugate.

[0104] Protein Activation: S. Enteri...

Embodiment 3

[0127] Example 3: Serological analysis of vaccines

[0128] Toxicity studies were performed on both bivalent and trivalent formulations, while immunogenicity studies were further performed on the trivalent vaccine alone. Both bivalent and trivalent formulations were designed with the same buffer components and the same strength of individual antigens. For the evaluation of the immunogenicity studies, only trivalent formulations were selected because trivalent formulations covered components of bivalent formulations. The results showed that the trivalent formulation gave a high fold increase of antibodies, so it is expected that the bivalent formulation as a separate vaccine should also express the same level of immunogenicity against the respective diseases.

[0129] Immunogenicity studies of a trivalent Salmonella conjugate vaccine drug product:

[0130] The Trivalent Salmonella Conjugate Vaccine drug product in multiple-dose vials and the Bivalent Salmonella Conjugate Vacc...

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Abstract

Disclosed are multivalent conjugate compositions against Salmonella diseases. A combined vaccine composition of glycol-conjugates in tetravalent, trivalent and bivalent combinations are disclosed in the present invention.

Description

[0001] Related Patent Applications [0002] This application claims priority and benefit from Indian Patent Application No. 201841017672 filed on November 10, 2018; the disclosure of which is incorporated herein by reference. [0003] field of invention [0004] The present invention relates to the field of polysaccharide conjugate immunogenic compositions such as vaccines. More specifically, the present invention relates to the field of polysaccharide conjugate compositions. The combined conjugate vaccine composition of the present invention is useful for prophylaxis against infections caused by Salmonella and non-typhoidal Salmonella infections causing typhoid fever. [0005] Background of the invention [0006] In humans, infections caused by Salmonella enterica depend primarily on the serovar of infection. Most invasive infections that cause typhoid are from what are known as Salmonella enterica serotype Typhi (S.typhi); Salmonella enterica serotypes A, B, and C Serovar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/112A61K47/64
CPCA61K47/6415A61K47/646A61K39/0275A61P31/04A61K2039/70A61K39/095A61K2039/6068A61K2039/6037Y02A50/30A61K39/116A61K47/10
Inventor 克里希纳·默斯·艾拉文卡特桑·拉马沙米曼达拉普·甘加达尔·奈杜
Owner BHARAT BIOTECH INTERNATIONAL