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Compositions and methods for treating viral infections

A composition, virus technology, applied in the field of compositions and methods for treating viral infections, capable of solving problems such as maintenance difficulties, non-strict compliance with cold chain procedures, equipment failure and power outages

Inactive Publication Date: 2015-01-21
VARIATION BIOTECHNOLOGIES INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Establishing cold chains for vaccine storage and distribution is major work and difficult to maintain
It is also clear that, despite best efforts, the cold chain does not always work as intended for a number of reasons, such as: poorly maintained or outdated refrigeration equipment, power outages leading to equipment Insufficient chain procedures and monitoring

Method used

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  • Compositions and methods for treating viral infections
  • Compositions and methods for treating viral infections
  • Compositions and methods for treating viral infections

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0113] Example 1: Reverse Melt Preparation of Antigen-Containing Vesicles

[0114] This example describes a reverse-melt formulation for the preparation of antigen-containing nonionic surfactant vesicles (NISV). In Step 1, a 5:4:1 molar ratio of the following lipids was placed in a 50 ml flat-bottomed glass beaker: 1-monopalmitin (MPG), cholesterol (CHO), and dicetyl phosphate (DCP), Make sure that no powder gets on the sides of the glass beaker. Melt the lipid at about 120 to 125°C for 10 minutes in a heated oil bath with occasional stirring in a glass oven covered with aluminum foil.

[0115] At this stage, the inactivated antigen vaccine (reconstituted according to the manufacturer's Sanofi Pasteur vaccine) stock solution in a heated water bath at about 30 to 35° C. for 5 to 10 minutes. In step 2, the resulting vaccine stock solution was homogenized at 8000 rpm at 30 to 35 °C, and the molten lipid mixture was added to the homogenized vaccine stock solution (to obtain 6....

Embodiment 2

[0116] Example 2: Study on thermal stability of antigen-containing vesicles prepared by reverse melting method

[0117] To assess thermal stability, NISV was prepared as described in Example 1, and lyophilized aliquots were stored at two different thermal storage temperatures (5±3°C and 40±2°C) (prior to reconstitution). ). If stored in a refrigerator at 2°C to 8°C, the freeze-dried Vaccines are stable; reconstituted vaccines are unstable and should be used immediately. in lyophilized or reconstituted form The vaccine is also stable at elevated temperatures. At specific times, stability samples were removed from the thermostat, reconstituted in WFI and analyzed for appearance, pH, microscopy, Zeta potential, nano size and ELISA (antigen content). The vaccine control (unformulated lyophilized Vaccine) (Test 7 (TA7)), stored as above but without the addition of NISV, was also tested.

[0118] Rabies virus antigen content in NISV preparations was determined by performi...

Embodiment 3

[0131] Example 3: In vivo animal testing of antigen-containing vesicles prepared by the reverse melting method

[0132] Female Balb / C mice (6 to 8 weeks old; body weight 18 to 28 grams, Charles River Canada Inc.) were immunized once (n=8) intramuscularly on day 0 (with 0.1 ml of the indicated vaccine samples). Serum samples collected before and after the first immunization were analyzed for formulated and unformulated Humoral immune response to vaccines. The humoral immune response was determined by performing an IgG ELISA serology assay. An indirect ELISA was performed to assess anti-rabies virus-specific IgG titers in immune sera. Briefly, rabies virus antigen ( Vaccine, Sanofi Pasteur) coated each well of a 96-well ELISA plate overnight at 4°C. The next day the plates were washed with PBS containing 0.05% Tween 20 and then blocked with PBS containing 10% goat serum (1 hour at 37°C). After the incubation time, the plates were washed six times in wash buffer (0.05% Twee...

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Abstract

The present disclosure provides compositions and methods useful for treating viral infections. As described herein, the compositions and methods are based on the development of immunogenic compositions that include an inactivated virus in combination with a non-ionic surfactant vesicle (NISV). In certain embodiments at least a portion of the antigen present in the composition is physically associated with the NISV. In certain embodiments the compositions are lyophilized and subsequently rehydrated after a period of storage. In certain embodiments the rehydrated compositions exhibit greater potency as compared to otherwise equivalent compositions that lack the NISV. In certain embodiments the lyophilized compositions are stored at temperatures in excess of 8° C. prior to rehydration. In certain embodiments the rehydrated compositions exhibit greater potency as compared to otherwise equivalent compositions that lack the NISV and that were also stored at temperatures in excess of 8° C. prior to rehydration. In certain embodiments the antigen is taken from a licensed vaccine and the administered dose of antigen is less than the standard human dose for the licensed vaccine.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of US Provisional Application Serial No. 61 / 585,971, filed January 12, 2012, the contents of which are hereby incorporated by reference in their entirety. Background technique [0003] Many viral infections cause serious health problems and may eventually lead to the death of the infected individual. One strategy for vaccination against such viral infections involves inactivating (or "killing") a previously virulent virus and administering it to an individual. The immune system can then later recognize the virulent form of the infectious agent and can respond either by neutralizing the infectious agent or by destroying cells that have been infected by the infectious agent. Several such inactivated vaccines have been developed, eg for poliovirus, rabies virus and hepatitis A. [0004] Poliovirus infection may cause mild illness that does not involve the central nervous system. Howeve...

Claims

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Application Information

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IPC IPC(8): A61K47/14A61K39/12A61K39/13A61K39/205A61K39/29A61K47/08A61K47/12A61K47/20A61K47/24A61K47/28A61K9/19A61P31/12A61P37/04
CPCA61K47/14A61K39/12A61K47/24A61K47/28A61K39/205C12N7/00C12N2760/20171A61K2039/55566C12N2760/20134A61K39/39A61K2039/55555A61P31/12A61P37/04Y02A50/30
Inventor 大卫·E·安德森
Owner VARIATION BIOTECHNOLOGIES INC