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Poly saccharide-protein combination vaccine

A combined vaccine and polysaccharide technology, applied in the directions of viral antigen components, antibodies, and antibody medical components, can solve the problems of poor polysaccharide antigen reactivity, short-term immune response, low affinity, etc., to improve immune coverage, enhance immunogenicity, The effect of a good immune response

Inactive Publication Date: 2003-06-25
BEIJING LUZHU BIOTECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Bacterial polysaccharides belong to T cell-independent antigens, which have the following characteristics: (1) only weak immune response can be produced in young animals or infants, or even no immune response, and the immune response increases with age; (2) Produce low-affinity antibodies, mainly IgM and a small amount of IgG antibodies; (3) only produce transient immune responses, without immune memory and immune enhancement effects during repeated vaccinations; (4) prone to immune tolerance; (5) Ordinary adjuvants are not easy to enhance immunity to this antigen
[0010] The thymus of infants under 2 years old is immature, and their reactivity to polysaccharide antigens is poor. After polysaccharides enter the body, they cannot be recognized by the body's immune system and cannot produce effective antibodies. Therefore, polysaccharide vaccines for children under 2 years old cannot produce protective antibody
However, if the polysaccharide conjugate vaccine is inoculated first, and then the tetanus toxoid is inoculated, only the enhancement of the tetanus toxoid antibody response can be seen, but there is no enhancement effect on the immunogenicity of the polysaccharide antigen of the vaccine

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1 A+C group meningococcal polysaccharide, Haemophilus influenzae type B polysaccharide-tetanus toxoid conjugate vaccine (1) Purification of polysaccharide

[0031] Suitable medium can be used for the production of polysaccharide vaccine. The liquid culture medium used for production should not contain components that can form a precipitate with the added cetyltrimethylammonium bromide. The culture medium should not contain harmful substances or other allergens.

[0032] After inoculating strains in a suitable medium, harvest after the logarithmic production period or before the stationary period. It is advisable to add formaldehyde solution to the culture for sterilization or heat sterilization to ensure the sterilization safety and not damage the polysaccharide of the bacteria. Centrifuge the sterilized single harvest (or combined harvest) to remove bacteria, collect the supernatant, add cetyltrimethylammonium bromide to it and mix it, and centrifuge to collect the...

Embodiment 3

[0048] Example 3 Groups A and C meningococcal polysaccharides, Haemophilus influenzae type B polysaccharides-mouse immunoglobulin (IgG) conjugate vaccine (1) Coupling of polysaccharides and mouse immunoglobulins (IgG) 1. Activated polysaccharides

[0049] Take A group (or C group) meningococcal (or Hib) polysaccharide 100mg (4mg / ml, 25ml), adjust the pH to 10.8 with 0.5M NaOH, add 50mg cyanogen bromide, and use 0.5M NaOH to maintain the pH at around 10.8±0.5 1 hour (22C). Then adjust the pH to 8.8 with 0.5M HCl, add 350mg adipic hydrazide (ADH), and react for 6 minutes; adjust the pH to 8.5 with 0.5M NaOH and maintain the pH within the range of 8.5±0.5 for 15 minutes; light at 4~8℃ Stir gently for 12 hours. Dialysis with pre-cooled 0.05M NaCl solution for 48 hours (4-8°C), during which time the fluid was changed 5 times (or ultrafiltration with a 100KD ultrafiltration membrane). The activated polysaccharide-ADH derivative was filtered with a 0.45μm filter membrane. 2. Coupling of ...

Embodiment 4

[0061] Example 4 Group A and C meningococcal polysaccharide, Haemophilus influenzae type B polysaccharide-human immunoglobulin (IgG) conjugate vaccine

[0062] The operation of this embodiment is the same as that of the third embodiment, except that the mouse serum immunoglobulin used in the third embodiment is replaced with human immunoglobulin for intravenous injection.

[0063] The conjugate vaccine prepared with human immunoglobulin as a carrier can be used for immunization of people of all age groups over 3 months old. The dosage range is 5-100μg / dose (calculated as polysaccharide), the number of immunizations is 2-3 times, and the immunization interval is 4-8 weeks.

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Abstract

Group A and Group C epidemuic cerebrospinal meningitis Neisseria capsular polysaccharide and type-B influenza Hemophilus polysaccharide are combined onto effective protein carrier chemically via covalent bond, so that combined polysacchairde-protein vaccine for immunologically inocualting human body is prepared to prevent infection caused by Group A and Group C epidemic cerebrospinal meningitis neisseria and type-B influenza Hemophilus.

Description

Technical field: [0001] The present invention relates to a vaccine preparation combining bacterial capsular polysaccharide and protein, in particular to a group A and C group epidemic cerebrospinal polysaccharide-protein combined vaccine and Haemophilus influenzae polysaccharide-protein combined vaccine. Background technique: [0002] Epidemic cerebrospinal meningitis is an infectious disease with a long history. The epidemic area is very wide, spreading to all continents of the world, and it has not been effectively controlled. [0003] Meningococcal is a common human infectious disease, which only infects humans. People are directly infected through droplets or secretions. Under normal circumstances, this contact makes the other person a healthy carrier. Depending on age and environment, 10-50% of people can become carriers. Under the influence of the human body's weakened resistance and certain environmental influences, Neisseria meningococcus can invade the bloodstream and th...

Claims

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Application Information

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IPC IPC(8): A61K31/12A61K39/12A61K39/13A61K39/145A61K39/395
CPCY02A50/30
Inventor 孔健蒋先敏吴冠江
Owner BEIJING LUZHU BIOTECH
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