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INVENTION
Russian Federation Patent RU2207150
Ways to reduce vaccine reactogenicity and antigenic
Name of the inventor: Shepelev AP .; Yagovkin EA .; Vacha BF
The name of the patentee: Rostov Research Institute of Microbiology and Parasitology; Scientific-Production Enterprise "Biomed"
Address for correspondence: 344010, Rostov-on-Don, trans. News, 119, Rostov Research Institute of Microbiology and Parasitology
Starting date of the patent: 2001.11.27
The invention relates to medicine, particularly to immunology, aimed at reducing the side effects of the vaccine, while maintaining their antigenic properties and can be used in vaccinology. The essence of the method is the preparation in doses potentiated vaccines and serial dilutions of antigen C 200 and C 30 received 1x and dilutions association in the ratio 1: 1: 2 respectively. The technical result is to reduce the reactogenicity of vaccines and antigens while maintaining the original antigenic activity.
DESCRIPTION OF THE INVENTION
The invention relates to medicine, particularly to immunology, and aims to reduce the side effects of the vaccine, while maintaining their antigenic properties and can be used in vaccinology.
In medicine, vaccination has been widely used to generate immunity in the population. Much of the effect of vaccination depends on the completeness of the coverage of vaccination (especially children). This prevents reactivity of existing vaccines, which can cause the development of immunopathological processes, so there are numerous contraindications that narrows grafting and reflected on epidemiological welfare.
To avoid unnecessary vaccination reactions using methods aimed at obtaining highly purified protective antigens and vaccines (Petrov RV, RM KHaitov. Artificial antigens and vaccines. M., 1988).
These methods require multistep and complex biotechnological approaches.
In vaccinology the most accepted method of reducing the level of reactogenicity is the use of reduced doses of vaccines (Td toxoid) (NV Medunitsyn vaccinology Moscow, 1999;.. Instructions for use Td toxoid, approved by the Russian Ministry of Health 15.04.98).
However, the application of ADS in reduced doses sufficient antibody response to the development of full immunity is not always possible to achieve. In this regard, the WHO Committee for some vaccines (diphtheria, tetanus) recommends the use of a vaccine with a normal dose, but to prevent unwanted reactions pharmacological agents and carry out specialized training of children to the risk of adverse reactions.
The aim of the process is to preserve the original antigenic activity of vaccines and antigens.
The solution of the problem is provided in that reduced dose vaccinates received by and potentiated homeopathic dilutions to 200 C, 30 C, 1x, are combined in a ratio of 1: 1: 2.
Example 1. Diphtheria-tetanus toxoid.
Take commercial vaccine Td 1 ml, which is obtained from homeopathic potentiation by a series of successive dilution method 1x vaccine, C 30, C 200. For one dose vaccinates taking 0.25 ml of 1X dilution, 0.125 ml of dilution C and 0.125 ml of 30 With 200 dilution of that mix and shaken vigorously.
Animals (white mice) were vaccinated intraperitoneally with doubly interval of 14 days at a dose of 0.5 ml of the following three formulations:
- Commercial preparation I. Background Td vaccine without dilution and potentiation;
- Preparation II. Commercial Td vaccine, diluted with distilled water, but not potentiated homeopathic method;
- Preparation III. Commercial Td vaccine, diluted with distilled water and potentiated homeopathic method according to the proposed method;
- Preparation of IV. Commercial Td vaccine.
14 days after the second vaccination blood is taken and serum levels determined antitoxic antibodies in the indirect hemagglutination commercial diagnosticums. The results presented in Table. 1 show that immunizing dose reduction reduces the antigenicity and antibody production, whereas dose reduction combined with dilution potentiation preserves the antigenicity of the vaccine.
The results of the delayed-type hypersensitivity in white mice on the introduction of diphtheritic-tetanus vaccines are given in the Table. 2.
From Table. 1 shows that the dose reduction reduces the reactogenicity of vaccines, but using the proposed method corresponds to the antigenicity of the vaccine Td.
Example 2. Leptospira concentrated liquid whole-cell vaccine.
Take 1 ml of the commercial Leptospira vaccine containing 250 thousand. Leptospira cells in 1 ml, and from it is obtained according to the method of the homeopathic dilution series of successive 1x vaccine, C 30, C 200. For one dose vaccinates taking 0.25 ml of 1X dilution 0,125 ml of dilution 30 and 0,125 ml of dilution With 200, which are mixed and shaken vigorously.
Animals (golden hamsters) doubly vaccinated intraperitoneally at intervals of 14 days at a dose of 0.5 ml of the following preparations:
- Commercial preparation I. Background Leptospira vaccine without dilution and potentiation;
- Preparation II. Commercial Leptospira vaccine, diluted with distilled water, but not potentiated homeopathic method;
- Preparation III. Commercial Leptospira vaccine, diluted with distilled water and potentiated homeopathic method according to the proposed method.
From Table. 3 shows that low doses of Leptospira vaccine potentiated homeopathic method according to the proposed method causes the formation of antibodies, equivalent of concentrated whole vaccine use.
The study was conducted by evaluating the reactogenicity of delayed type hypersensitivity (DTH) test in albino mice paw edema. The results are shown in Table. 4.
The results show that the intensity of the DTH reactions was expressed in the animals when applying concentrated vaccine and could not be detected practically using formulations II and III groups.
Thus, the proposed method reduces the reactogenicity of the vaccine due to its dilution. The level of antigenicity of the vaccine of the present method is equivalent to the use of concentrated whole vaccine.
Example 3. Antigen capsular Haemophilus influenzae type B (Hib).
Take 1 ml of the capsular polysaccharide antigen solution containing 1 ml of 20 mcg polysaccharide Hib, which is obtained from homeopathic potentiation by a series of successive dilution method 1x antigen, C 30, C 200.
For single-dose vaccinates take 0.25 ml of 1x dilution, 0.125 ml of dilution 30 and 0,125 ml of dilution With 200, which are mixed and shaken vigorously.
Animals (white mice) were vaccinated intraperitoneally with doubly interval of 20 days at a dose of 0.5 ml of the following preparations:
- Preparation of I. The source of antigen - capsular polysaccharide (Hib) without dilution and potentiation;
- Preparation II. The capsular polysaccharide (Hib), diluted with distilled water, but not potentiated homeopathic method;
- Preparation III. The capsular polysaccharide (Hib), diluted with distilled water and potentiated homeopathic method according to the proposed method.
14 days after the second vaccination blood is taken and determine the level of serum antibodies to capsular antigen Hib response in enzyme immunoassay. The results are shown in Table. 5.
The study was conducted by evaluating the reactogenicity of delayed type hypersensitivity (DTH) test in albino mice paw edema. The results are shown in Table. 6.
Thus, for potentiating properties of reduced reactogenic vaccines for homeopathic method while maintaining the antigenicity of drugs that antibody is detected in experimental animals.
CLAIM
Method reduce reactogenicity of vaccines and antigens through the use of reduced dose vaccinates, characterized in that the vaccines of antigens are prepared and potentiated doses in successive dilutions of 200 C, 30 C and 1x and the resulting dilution is combined in a ratio of 1: 1: 2 respectively.
print version
Publication date 02.04.2007gg
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