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Thermosensitive hepatitis B vaccine

A hepatitis B, sensitive technology, applied in the field of hepatitis B vaccine

Active Publication Date: 2014-12-24
IND TECH RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, a minority (approximately 5-10%) of normal vaccine recipients and approximately 40-50% of patients undergoing routine hemodialysis (patients with renal failure) have no immune response to current HBsAg vaccines
[0005] At present, the mechanism of non-response to HBsAg vaccine has not been fully confirmed, but evidence from genetic research points out that HLA-DR alleles are closely related to low vaccine response, and different races have different HLA-DR alleles. DR allele

Method used

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  • Thermosensitive hepatitis B vaccine
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] The assembly equipment is a condensing tube, and the condensing tube is wrapped with a heating belt device, which can remelt the monomers precipitated during the reaction. The reactor is a 250mL columnar glass vessel (8cmx8cmx10cm), with a heater and a temperature controller. , Use mechanical stirring to carry out polymerization reaction. Before polymerization, first raise the temperature to above 100°C, and pass nitrogen gas for 30 minutes to remove impurities and moisture. 26g of methoxypolyethylene glycol (mPEG, molecular weight 550g / mol), 50g of lactide and 17g of glycolide were sequentially added into the reactor, and the temperature was raised slowly until completely dissolved. The temperature was raised to 110°C sequentially, at this time, 37 μl of catalyst (Stannous 2-ethyl-Hexanoate, 2-ethylhexanoate) was added, and the reaction temperature was 150°C. The polymerization reaction was carried out for 8 hours, and the product was precipitated with ether / n-hexane (...

Embodiment 2

[0024] HBsAg (yeast-derived recombinant) (2μg), and mouse GM-CSF (cultivated by Pichia pastoris yeast) (5.4μg or 4.5x10 4 U)) and 0.2ml of the aqueous phase solution prepared in Example 1 (comprising biodegradable temperature-sensitive hydrogel copolymer mPEG 550 -PLGA 1405 ) mixed to obtain temperature-sensitive hepatitis B vaccine.

[0025] Hepatitis B antibody level measurement

Embodiment 3

[0027]The experimental mice were divided into 6 groups, and the following vaccines were administered to each group of experimental subjects: (1) 2 μg HBsAg placed in saline (saline), (2) 2 μg HBsAg+5.4 μg GM-CSF placed in physiological saline In water, (3) 2 μg HBsAg was placed in the aqueous phase solution prepared in Example 1, (4) the temperature-sensitive hepatitis B vaccine described in Example 2 (2 μg HBsAg+5.4 μg GM-CSF was placed in the solution prepared in Example 1 prepared aqueous phase solution), (5) separately inject 2 μg of HBsAg (which is placed in the aqueous phase solution prepared in Example 1) and 5.4 μg GM-CSF (which is placed in the aqueous phase solution prepared in Example 1) ), and (6) 2 μg H-B-Vax II (Merck Sharp & Dohme West Point, PA) (commercially available vaccine with aluminum hydroxide as adjuvant). The BALB / c mice used were between 6 and 8 weeks old.

[0028] Next, collect the serum of each group of experimental mice and calculate the HBs antib...

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Abstract

A thermosensitive hepatitis B vaccine is provided. The thermosensitive hepatitis B vaccine includes an aqueous phase solution comprising a biodegradable thermosensitive hydrogel copolymer; a surface antigen of hepatitis B virus (HBsAg); and a bioactive substance. The thermosensitive hepatitis B vaccine of the disclosure is particularly suitable for being applied in the patients, which are low responsive or non-responsive to conventional hepatitis B vaccine, for enhancing the induction of cell-mediated immune responses and overcoming the HBsAg non-responsiveness.

Description

technical field [0001] The invention relates to a hepatitis B vaccine, in particular to a temperature-sensitive hepatitis B vaccine. Background technique [0002] According to the statistics of the World Health Organization (WHO), more than one-third of the world's population has been infected with hepatitis B virus (hepatitis B virus, HBV), and there are about 350 million chronic hepatitis B virus carriers Among them, 15% to 25% of patients are at risk of liver disease complicated by hepatitis B virus, and even develop into liver cirrhosis or liver cancer. About one million people die from hepatitis B every year. [0003] The main countermeasure used to prevent hepatitis B virus infection and transmission is the vaccination of hepatitis B virus surface antigen (HBsAg). The current standard three-dose hepatitis B virus vaccine (from the plasma of HBV carriers or produced by genetic recombination technology) can make about 90% of the vaccinees successfully produce hepatitis ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/39A61K47/34A61P1/16A61P31/20
CPCA61K2039/55522A61K9/0024A61K47/34C12N2730/10134A61K39/292A61K39/12A61K2039/57A61P1/16A61P31/12A61P31/20
Inventor 陶秘华周和源沈欣欣林才佑
Owner IND TECH RES INST
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