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Vaccine composition

A composition, immunogenic technology, applied in the field of vaccine composition

Active Publication Date: 2012-09-05
SERUM INST OF INDIA PTE LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Existing standalone IPV formulations do not contain adjuvants

Method used

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  • Vaccine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0084] Process for preparing an oil-in-water emulsion and combining the emulsion with an IPV vaccine

[0085] According to the document [Ott et al., The adjuvant MF59: a 10-year perspective. In-vaccine adjuvants: preparation methods and research protocols. Methods in Molecular medicine, vol 42, chapter 12, p211-228. Edited by D.T.O'Hagan (2000 )] to prepare oil-in-water emulsions. Briefly, 9.75 g squalene (Sigma, from shark liver) was mixed with 1.175 g sorbitan trioleate. Separately 1.175 g of polysorbate 80 was mixed with 240 ml of 10 mM pH 6.5 citrate buffer before adding to the squalene-sorbitan trioleate solution. The mixture was further homogenized for 1 minute using a bench top homogenizer (Silverson). Immediately after that, the material was subjected to five-channel high-pressure microfluidization using a Microfluidics M110H microfluidizer (Microfluidics, MA, USA). The size of the oil droplets was verified to be less than 150 nm using a Malvern laser particle size ...

Embodiment 2

[0088] Immunization and immunogenicity evaluation in rats

[0089] Rats (n=5) were injected intramuscularly twice (days 0 and 28) with 0.1 ml of A) full-strength IPV; B) IPV diluted 10 times with PBS and C) IPV diluted 10 times with the above emulsion. immunity. Sera were collected on day 42 and evaluated for poliovirus neutralization titers for all three of the IPV vaccines.

[0090] The geometric mean titers for virus neutralization are shown in the table below

[0091] Table 1 Geometric mean titer (N=5)

[0092]

[0093] (The values ​​in brackets represent the geometric mean deviation)

[0094] This demonstrates that when combined with an oil-in-water emulsion, a 1 / 10th dose of the IPV vaccine elicited an immune response at least as effective as that elicited by the full-dose vaccine without adjuvant.

[0095] The addition of adjuvants to IPV vaccines therefore allows for a reduction in vaccine dose and allows the use of lower doses of antigen for vaccination.

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Abstract

The application provides cost effective immunogenic IPV formulations.The said formulations contain an adjuvant that can enable 5 to 10 fold dose reduction for inactivated polio virus vaccines.

Description

technical field [0001] The present invention relates to a vaccine for use against poliovirus types 1, 2 and 3, in particular comprising reduced amounts of inactivated poliovirus D antigen in monovalent or multivalent form and an adjuvant to elicit protection against poliovirus Vaccine field for immunization. Background technique [0002] Inactivated poliovirus vaccines (IPV) currently registered and used are based on non-attenuated (Salk) poliovirus vaccines and strains: they are therefore also referred to as wild-type IPV (wtIPV). IPV is delivered by intramuscular (IM) or deep subcutaneous (SC) injection. IPV is currently available as an unadjuvanted stand-alone formulation or in various combinations, including DT-IPV (with diphtheria and tetanus toxoids) and the hexavalent DTPHepB-Hib-IPV vaccine (in addition to pertussis, hepatitis B and Haemophilus influenzae type b together) obtained. Future global demand for IPV following poliovirus eradication could increase from t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/13A61K47/00
CPCA61K39/12A61K39/13A61K2039/5252A61K2039/55566C12N2770/32634Y02A50/30
Inventor 贾达夫·谢瑞克·萨卡拉姆加伊罗拉·苏尼·贾格迪什普拉萨德高塔姆·玛尼西·马赫什库马
Owner SERUM INST OF INDIA PTE LTD