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Immunogenic Substances Comprising A Polyinosinic Acid-Polycytidilic Acid Based Adjuvant

a polynucleotide complex and immunogenic composition technology, which is applied in the field of immunogenic compositions, can solve the problems of ineffective use of polyinosinic acid-polycytidylic acid (pic), one of the most studied polynucleotide complexes, and inability to provide optimal efficacy/safety profile, and induce unacceptable adverse side effects

Inactive Publication Date: 2009-07-09
YISHENG BIOPHARMA SINGAPORE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Polyinosinic acid-polycytidylic acid (PIC), one of most studied polynucleotide complexes, was not effective when used in monkeys and humans due to its instability in the body after administration.
However, Lin found that that the form of PICKCa originally identified does not provide the optimal efficacy / safety profile for use as an adjuvant and also induces unacceptable adverse side effects under certain conditions.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

PIKA In Combination with a Variety of Antigens Induces a Specific Immune Response

[0261]This example involves use of PIKA in combination with a variety of antigens to elicit a specific immune response in vivo. The research was conducted in a series of independent experiments with a common protocol though using a different antigen each time. The antigens tested include: a recombinant protein hepatitis B surface antigen type adw, an inactivated split influenza vaccine (VAXIGRIP from Sanofi Pasteur), a synthesized HIV peptide antigen, a recombinant protein herpes simplex virus type 2 gD antigen, recombinant protective anthrax protein antigen, inactivated whole virus avian influenza antigen strain H5N1 and an inactivated whole virus Severe Acute Respiratory Syndrome (SARS) inactivated antigen.

[0262]The protocol for the individual experiment involves the inoculation of groups of Balb / c mice, three mice per group, with compositions of antigen alone, antigen with the PIKA adjuvant (a hetero...

example 1.1

Recombinant Hepatitis B Surface Antigen (HBSAg) adw

[0268]The results in table 6 below are the results of the ELISPOT test detecting the presence number of cells producing INF-γ, IL-2 and IL-4 using a recombinant protein hepatitis B surface antigen (HBsAg) type adw. The data in the table 6 (see also FIGS. 1, 2 and 3) represent the ELISPOT reading, the number of spot forming cells, that is, a direct measure the number of cells producing cytokine.

[0269]The distinct increase in the number of spot forming cells with the addition of the PIKA adjuvant (as compared with the antigen alone) demonstrates that the addition of the PIKA adjuvant to recombinant hepatitis B surface antigen enhances the expression of cytokines INF-γ, IL-2 and IL-4 by cultured spleen cells. The observed expression of cytokines indicates an enhanced adaptive immune response of both a humoral and cell mediated immunity induced by the presence of the PIKA adjuvant.

TABLE 6ELISPOT detection of murine splenocytes producing...

example 1.2

VAXIGRIP (Sanofi Pasteur), Inactivated and Purified Influenza Antigen Comprising; H1N1, H3N2 Like Strains and b / Shanghai5 / 36112002 Strain

[0272]The results in table 8 below are the results of the ELISPOT test detecting the presence the number of cells producing INF-γ, IL-2 and IL-4 using VAXIGRIP vaccine a inactivated split human influenza vaccine produced by Sanofi Pasteur. The data in the table 8 (see also FIGS. 5, 6 and 7) represent the ELISPOT reading, the number of spot forming cells, that is, a direct measure of cytokine production.

[0273]The distinct increase in the number of spot forming cells with the addition of the PIKA adjuvant (as compared with the antigen alone) demonstrates that the addition of the PIKA adjuvant to the influenza antigen enhances the expression of cytokines INF-γ, IL-2 and IL-4 by cultured spleen cells. The observed expression of cytokines indicates an enhanced adaptive immune response of both a humoral and cell mediated immunity induced by the presence ...

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Abstract

The present invention provides a polynucleotide adjuvant (PICKCa) composition and methods of use in eliciting an immune response, in particular a mucosal immune response. The polynucleotide adjuvant comprises of a polyriboinosinic-polyribocytidylic acid (PIC), at least one antibiotic and at least one positive ion. The present invention also provides an immunogenic composition comprising the polynucleotide adjuvant composition together with other immunogenic compositions such as an antigen (e.g., as in a vaccine) selected from viral, bacterial, fungal, parasitic and / or cancer antigens. The present invention further contemplates methods of use of such adjuvant compositions, particularly in eliciting an immune response, in particular a mucosal immune response to an antigenic compound.

Description

FIELD OF INVENTION[0001]The invention generally relates to immunogenic compositions and methods of their use. More specifically the invention relates to an immunogenic composition comprising a polynucleotide adjuvant in combination with one or more antigenic substances to be used to elicit disease specific immune response in a host.BACKGROUND OF INVENTION[0002]The immune system may exhibit both specific and nonspecific immunity. Nonspecific immunity encompasses various cells and mechanisms such as phagocytosis (the engulfing of foreign particles or antigens) by macrophages or granulocytes, and natural killer (NK) cell activity, among others. Nonspecific immunity relies on mechanisms less evolutionarily advanced and does not display the acquired nature of specificity and memory, which are exemplary hallmarks of a specific immune response. The key differences between specific and nonspecific immunity are based upon B and T cell specificity. These cells predominantly acquire their resp...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K39/12A61K39/235A61K39/155A61K39/21A61K39/145A61K39/275A61K39/02
CPCA61K33/00A61K2039/55561A61K45/06A61K39/39A61P31/00A61P31/04A61P31/10A61P31/12A61P31/14A61P31/16A61P31/18A61P31/20A61P31/22A61P33/00A61P35/00A61P37/00A61P37/04Y02A50/30A61K33/06C12P19/34A61K39/00
Inventor LIN, HAIXIANGLI, LIE TAO VICTOR
Owner YISHENG BIOPHARMA SINGAPORE
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