Combination vaccine composition comprising reduced dose inactivated poliovirus and method for preparing the same

A composition and inactivation technology, applied in biochemical equipment and methods, medical preparations without active ingredients, medical preparations containing active ingredients, etc., can solve the problems of saturated adsorption capacity and incomplete adsorption of antigens.

Pending Publication Date: 2021-07-23
SERUM INST OF INDIA PTE LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0060] d) Individual or combined adsorption of antigens on adjuvants, where combined adsorption has the advantage of ease of operation, while disadvantages include where the first pre-adsorbed antigen is partially or completely desorbed during the addition of subsequent antigens
Antigen added in the last step may not be fully adsorbed as previous antigen may have saturated the adsorption capacity

Method used

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  • Combination vaccine composition comprising reduced dose inactivated poliovirus and method for preparing the same
  • Combination vaccine composition comprising reduced dose inactivated poliovirus and method for preparing the same
  • Combination vaccine composition comprising reduced dose inactivated poliovirus and method for preparing the same

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Experimental program
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no. 1 approach

[0090] According to a first embodiment of the present disclosure, the combination vaccine composition includes, but is not limited to, an antigen / immunogen selected from the group consisting of Diphtheria Toxoid (D), Tetanus Toxoid (T), Whole Cell Pertussis Bordet influenzae (wP), Haemophilus influenzae type b (Hib) PRP-CP conjugate, hepatitis B (HepB), reduced doses of inactivated poliovirus (IPV), and additionally 2-phenoxyethanol and at least one A combination of paraben preservatives.

[0091] According to the second embodiment of the present disclosure, the combination vaccine composition may further include one or more antigens, which are respectively selected from but not limited to the group consisting of: Haemophilus influenzae (a, c, d , e, f serotypes and acapsulated strains), hepatitis (A, C, D, E, F and G strains), Neisseria meningitidis A, B, C, Y, W-135 or X, Influenza, Staphylococcus aureus, Salmonella typhi antigen, acellular pertussis antigen, modified adeny...

no. 5 approach

[0108] According to the fifth embodiment of the present disclosure, IPV (Sabin strain or Salk strain) may not be adsorbed on any adjuvant alone and then added to the final combination vaccine composition.

[0109] According to a preferred aspect of the fifth embodiment, IPV (Sabin strain or Salk strain) can be adsorbed on an adjuvant, more preferably on aluminum phosphate or aluminum hydroxide present in the combination vaccine, wherein the IPV antigen, for The percent adsorption of IPV type 1 can range from 10% to 30%, the percent adsorption of IPV type 2 can range from 60% to 100%, and the percent adsorption of IPV type 3 can range from 0% to 25% Inside.

no. 6 approach

[0110] According to the sixth embodiment of the present disclosure, IPV (Sabin strain or Salk strain) components can be adsorbed individually to an adjuvant selected from the group consisting of aluminum salt (Al 3+ ), such as aluminum hydroxide (Al(OH) 3 ) or aluminum phosphate (AlPO 4 ), alum, calcium phosphate, MPLA, 3D-MPL, QS21, CpG-containing oligodeoxynucleotide adjuvants, liposomes or oil-in-water emulsions or combinations thereof. (eg, before or after mixing with other ingredients, if present). If adsorbed, one or more IPV components can be adsorbed on aluminum hydroxide (Al(OH) 3 ) or aluminum phosphate.

[0111] IPV (Sabin strain or Salk strain) components can be adsorbed onto aluminum salts by the following procedure:

[0112] Take the desired volume of autoclaved Al(PO) 4 or Al(OH) 3 To achieve the final alum (Al 3+ ) at a concentration of 0.1 mg to 0.8 mg / dose,

[0113] • Add bulk IPV with adjusted D-Ag units and make up volume with diluent (10x M-199+0.5...

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Abstract

The present disclosure relates to a fully liquid immunogenic composition comprising a combination of antigens / immunogens. The immunogenic composition comprises optimum amount of antigens / immunogens to confer protection against a number of diseases. The composition exhibits improved immunogenicity and stability. A process for preparing the vaccine composition is also disclosed.

Description

technical field [0001] The present disclosure relates to the field of biotechnology, and more specifically, it relates to methods of preparing multi-dose combination vaccine compositions comprising a set of antigens / immunogens and preservatives. The present disclosure further relates to improved methods in the field of combination vaccine production. Background technique [0002] Combination vaccines that provide immunogenicity against many diseases are always superior to monovalent vaccines because of fewer injections, fewer complications associated with multiple intramuscular injections, reduced administration and production costs, reduced storage costs, and fewer delays or misses risk of vaccination and improved patient compliance by reducing the number of separate vaccinations. Furthermore, completely liquid formulations of combination vaccines have significant advantages over those requiring reconstitution. The average preparation time for fully liquid vaccines was al...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/00A61K39/02A61K39/13A61K39/29A61P31/00
CPCA61K39/0018A61K39/099A61K39/13A61K39/292A61K2039/5252A61K2039/70C12N2730/10134C12N2770/32634A61P31/00Y02A50/30A61K39/295A61K39/05A61K39/08A61K39/102A61K9/08A61K47/06A61K47/10A61K47/02A61P31/04A61P31/12A61K2300/00A61K47/14A61K2039/10A61K2039/521A61K2039/55505A61K2039/6037C12N7/00
Inventor 因德·吉特·夏尔马拉凯什·库马尔贾甘纳坦·森堡拉卡基安南·基尔文尼马诺哈尔·多达帕尼尼阿尼·维扬卡特拉奥·希托勒
Owner SERUM INST OF INDIA PTE LTD
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