Application of hepatitis B surface antigen-antibody complexes in preparing prophylaxis product with no response or low response to hepatitis B vaccine

Abstract

The invention discloses a new utility of hepatitis B surface antigen-antibody compound in the hepatitis B vaccine non-respond or low-respond prevention agent, which is characterized by the following: purifying recombined HBsAG or inactivated serum HBsAG in the mammal cell, adopting hepatitis B with antibody serum or vaccine globulin as compound, improving anti-HBs ability for non-respond or low-respond mouse.

Description

technical field

[0001] The invention belongs to the field of biological products. The invention relates to a new use of the hepatitis B surface antigen-antibody complex, in particular to the use of the hepatitis B surface antigen-antibody complex in preparing non-responsive or low-response preventive products for hepatitis B vaccine. Background technique

[0002] At present, the existing hepatitis B preventive vaccines at home and abroad have made important contributions in preventing the occurrence and development of hepatitis B and liver cancer (Beasley RP et al, Lancet, 2: 1099, 1983; Lo KJ et al, J Inf Dis152: 817, 1985; Sha Qinghong et al., Acta Virology vol 7 suppl: 56, 1991. The vaccines currently used to prevent hepatitis B are all made of hepatitis B surface antigen protein (HBsAg), which is derived from plasma purification and inactivation, using recombinant yeast gene Hepatitis B surface antigen protein expressed by engineered bacteria or expressed in mammalian c...

Examples

Embodiment 1

[0012] Two different strains of mice B10 and B10s (histocompatibility are both H2f, (Jackson co.) the former is a responsive strain to HBsAg, the latter is a non-responsive strain) were immunized with HBsAg and HBsAg-anti-HBs respectively, Results HBsAg alone could not induce the same level of anti-HBs in B10s as the B10 strain, but HBsAg-anti-HBs could induce the same level of anti-HBs in B10s as the B10 strain.

[0013] According to the results of square array titration and the determination of residual HBsAg and anti-HBs, 27.5 μg of HBsAg purified from blood (added in 2 times) was added, diluted 1:30, and the titer ELISA was 1:3200 mouse antibody - 47 μl of HBs to make HBsAg-anti-HBs, another 27.5 μg of the same batch of HBsAg was added to 47 μl of phosphate buffer as a control for HBsAg injection. Take 10 B10 mice and 10 B10s mice respectively without adjuvant. Each mouse is injected intramuscularly with 1 μg HBsAg or HBsAg-anti-HBs complex containing 1 μg HBsAg, and immun...

Embodiment 2

[0018] For Balb / c mice that respond to hepatitis B vaccine (HBsAg), first use cyclosporin A (cyclosporinAclin Exp Immunol 1989, 78: 263-70; World J Gastroenterol 1999, 5: 209-212;), and then use Simple HBsAg expressed by yeast genetic engineering or HBsAg-expressed by yeast genetic engineering was immunized with mouse anti-HBs, and the anti-HBs titer was determined by ELISA after serum was collected. Results The anti-HBs titer of HBsAg-anti-HBs immunized mice was significantly higher than the anti-HBs titer of HBsAg immunized mice alone, indicating that the HBsAg-anti-HBs complex can be used for immunocompromised hepatitis B vaccine (HBsAg) ineffective Responsive or low-responsive organisms are used as preventive preparations.

[0019] Get 24 Balb / c rats with a weight of 16-20 grams, and inject 0.5 mg of cyclosporin A (cyclosporin A) intraperitoneally into each of 20 (diluted with normal saline, and then inject 0.1-2 cyclosporin every other day. In addition 4 rats were only i...

technical field

[0001] The invention belongs to the field of biological products. The invention relates to a new use of the hepatitis B surface antigen-antibody complex, in particular to the use of the hepatitis B surface antigen-antibody complex in preparing non-responsive or low-response preventive products for hepatitis B vaccine. Background technique

[0002] At present, the existing hepatitis B preventive vaccines at home and abroad have made important contributions in preventing the occurrence and development of hepatitis B and liver cancer (Beasley RP et al, Lancet, 2: 1099, 1983; Lo KJ et al, J Inf Dis152: 817, 1985; Sha Qinghong et al., Acta Virology vol 7 suppl: 56, 1991. The vaccines currently used to prevent hepatitis B are all made of hepatitis B surface antigen protein (HBsAg), which is derived from plasma purification and inactivation, using recombinant yeast gene Hepatitis B surface antigen protein expressed by engineered bacteria or expressed in mammalian c...

Examples

Embodiment 1

[0012] Two different strains of mice B10 and B10s (histocompatibility are both H2f, (Jackson co.) the former is a responsive strain to HBsAg, the latter is a non-responsive strain) were immunized with HBsAg and HBsAg-anti-HBs respectively, Results HBsAg alone could not induce the same level of anti-HBs in B10s as the B10 strain, but HBsAg-anti-HBs could induce the same level of anti-HBs in B10s as the B10 strain.

[0013] According to the results of square array titration and the determination of residual HBsAg and anti-HBs, 27.5 μg of HBsAg purified from blood (added in 2 times) was added, diluted 1:30, and the titer ELISA was 1:3200 mouse antibody - 47 μl of HBs to make HBsAg-anti-HBs, another 27.5 μg of the same batch of HBsAg was added to 47 μl of phosphate buffer as a control for HBsAg injection. Take 10 B10 mice and 10 B10s mice respectively without adjuvant. Each mouse is injected intramuscularly with 1 μg HBsAg or HBsAg-anti-HBs complex containing 1 μg HBsAg, and immun...

Embodiment 2

[0018] For Balb / c mice that respond to hepatitis B vaccine (HBsAg), first use cyclosporin A (cyclosporinAclin Exp Immunol 1989, 78: 263-70; World J Gastroenterol 1999, 5: 209-212;), and then use Simple HBsAg expressed by yeast genetic engineering or HBsAg-expressed by yeast genetic engineering was immunized with mouse anti-HBs, and the anti-HBs titer was determined by ELISA after serum was collected. Results The anti-HBs titer of HBsAg-anti-HBs immunized mice was significantly higher than the anti-HBs titer of HBsAg immunized mice alone, indicating that the HBsAg-anti-HBs complex can be used for immunocompromised hepatitis B vaccine (HBsAg) ineffective Responsive or low-responsive organisms are used as preventive preparations.

[0019] Get 24 Balb / c rats with a weight of 16-20 grams, and inject 0.5 mg of cyclosporin A (cyclosporin A) intraperitoneally into each of 20 (diluted with normal saline, and then inject 0.1-2 cyclosporin every other day. In addition 4 rats were only i...