Lipid and Nitrous Oxide Combination as Adjuvant for the Enhancement of the Efficacy of Vaccines

a technology of nitrous oxide and vaccine, which is applied in the direction of antibacterial agents, antibody medical ingredients, immunological disorders, etc., can solve the problems of inability to induce an appropriate, protective, immune response, and sustainably deliver vaccines to everyone at risk, so as to enhance the action of antigens, enhance the immune response, and enhance the effect of specific neutralizing antibodies

Inactive Publication Date: 2009-01-08
EXHAUSTO +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0036]It is an object of the present invention to provide an adjuvant with the characteristic of enhancing the action of antigens, and to provide pharmaceutical preparations of such adjuvants in conjunction with antig

Problems solved by technology

While microbicides may usefully extend prevention options and serve as valuable prototypes for vaccine development, it is not clear that these can be delivered sustainably to everyone at risk.
A major hindrance that has prevented the development of effective mass immunization programs is the inability to induce an appropriate, protective, immune response.
Such a response can be extremely difficult to elicit, especially by recombinant, soluble protein subunits.
This deficiency is due to the inability of these antigens to access the machinery of the appropriate antigen-processing pathway.
Furthermore, products given by syringe are inherently more expensive than those which can be taken by mouth or—for example—as a nasal spray.
The danger of re-use of needles in underdeveloped countries is a compounding factor.
Despite the urge for an efficient mucosal vac

Method used

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  • Lipid and Nitrous Oxide Combination as Adjuvant for the Enhancement of the Efficacy of Vaccines
  • Lipid and Nitrous Oxide Combination as Adjuvant for the Enhancement of the Efficacy of Vaccines
  • Lipid and Nitrous Oxide Combination as Adjuvant for the Enhancement of the Efficacy of Vaccines

Examples

Experimental program
Comparison scheme
Effect test

preparation 1

Preparation of FAA-1 for the Parenteral Rabies and Nasal Diphtheria Toxoid (DT)-Vaccines

[0127]Step 1: The buffer solution applicable to the specific antigen is saturated with nitrous oxide at ambient pressure using a pressure vessel and sparger. In the case of rabies the buffer used was phosphate buffered saline (PBS), in the case of the DT for nasal administration, distilled water was used.[0128]Step 2: The following group of fatty acids was heated to 70° C.: 21% oleic acid, 34% linolenic acid, and 28% linoleic acid. These fatty acids were modified by esterification with an ethylene group of the carboxy terminal. The pegylated, hydrogenated fatty acid, ricinoleic acid (also known by the INCI name as PEG-n-Hydrogenated Castor Oil), was heated to 80° C. and mixed with the first group of fatty acids at 70° C. The ratio of the first group of fatty acids to the latter fatty acid was 3:1.[0129]Step 3: The buffer solution was heated to 70° C. and mixed with the fatty acid mix to a final c...

preparation 2

Preparation of FAA-2 for Parenteral Hepatitis 6 Vaccine

[0131]To the fatty acids contained in FAA-1 above was added[0132]1. dl-a-Tocopherol as anti-oxidant[0133]2. additional ethylated fatty acids DHA (decahexonoic acid) and EPA (eicosapentaenoic acid). The preferable amount of the two fatty acids for this invention was 0.2%.[0134]3. Entrapment of the Hepatitis B peptide occurred by mixing for 30 minutes in a Vibramix at ambient temperature.

[0135]Stable particles of fairly homogeneous sizes ranging from 20 nm to 50 μm can be manufactured with ease on a large scale. The size and shape of the particles can be reproducibly controlled. The use of FAA-1 and FAA-2 in animal studies as it pertains to this invention is described below. The following antigens considered to be representative and hence demonstrative albeit not exhaustive of the range of vaccines to which the invention relates, were used in the cell and animal studies to confirm the invention:

A toxoid as antigen (diphtheria)

An i...

example 1

Determination of the Capacity of an FAA-1 / DT Vaccine to Induce a Systemic Immune Response after Oral and Nasal Administration Respectively

[0137]This example pertains to the enhancement of the immune response to the diphtheria toxoid specifically in a nasally and orally administered vaccine in animals in comparison to the currently used gold standard—an aluminium hydroxide (alum)-based parenteral vaccine.

1. Objective of the Study:

[0138]The primary objective of this study was to assess the efficacy of FAA-derived formulations of the present invention in enhancing the systemic immune response after oral and nasal administration of the model antigen DT when compared with antigen administered in

a) PBS saline

b) Alum by parenteral route.

[0139]Desai et al16 showed that chitosan particle uptake by M-cells is dependent on the size of the particles as well as the hydrophobic / hydrophilic character of the particles. It has been established that particles with sizes in the nanometer range are mor...

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Abstract

The invention provides for a method of enhancing immunological responses to an antigen in a vaccine formulation, and for a vaccine formulation that provides for an enhanced immunological response to an antigen. In the method and formulation the antigen is administered with an adjuvant which adjuvant comprises a solution of nitrous oxide gas in a pharmaceutically acceptable carrier solvent for the gas and which adjuvant includes at least one fatty acid or ester or other suitable derivative thereof selected from the group consisting of oleic acid, linoleic acid, alpha-linolenic acid, gamma-linolenic acid, arachidonic acid, eicosapentaenoic acid [C20: 5ω3], decosahexaenoic acid [C22: 6ω3], ricinoleic acid and derivatives thereof selected from the group consisting of the C1 to C6 alkyl esters thereof, the glycerol-polyethylene glycol esters thereof and the reaction product of hydrogenated natural oils composed largely of ricinoleic acid based oils, such as castor oil with ethylene oxide.

Description

FIELD OF THE INVENTION[0001]This invention relates to pharmaceutical preparations (which expression is herein intended to include veterinary preparations) for use in the prevention of disease by inoculation against infective organisms afflicting the animal body (which expression is herein intended to include the human body).BACKGROUND TO THE INVENTION[0002]In EP 93912877.3 and U.S. Pat. No. 5,633,284 and their equivalents there is disclosed that dermatological or topical compositions comprising the combination of nitrous oxide [N2O] and at least one fatty acid, or lower alkyl ester thereof, in a dermatologically acceptable carrier medium, are useful in the treatment of a variety of skin, muscle and joint disorders. It further disclosed therein that such combinations might beneficially also include additional active ingredients. The following active ingredients are specifically mentioned in this regard: coal tar solution, collagen, nicotinamide, nicotinic acid, lanolin, vitamin E, me...

Claims

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Application Information

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IPC IPC(8): A61K39/145A61K39/00A61K39/12A61K39/02A61K39/07A61K39/106A61K39/102A61K39/095A61K39/13A61P37/02A61K47/12A61K39/25A61K39/20A61K39/205A61K39/165A61K39/10A61K39/09A61K39/08A61K39/112A61K39/05A61K39/29
CPCA61K39/39A61K2039/55544A61K39/292A61K39/05A61K39/205A61K2039/55555A61P31/00A61P31/04A61P31/12A61P31/16A61P37/02Y02A50/30
Inventor GROBLER, ANNEKOTZE, ABRAHAM FREDERIK
Owner EXHAUSTO
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