Adjuvant-free single-dose HBsAg nanogel vaccine and preparation method thereof

A nanogel, single-dose technology, applied in the field of biomedicine, can solve the problems of high frequency of aluminum adjuvant vaccine immunization, short immunization memory time of aluminum adjuvant vaccine, and affecting the safety of the vaccinated population, achieving good immune effect, The effect of avoiding adverse reactions and reducing the frequency of administration

Active Publication Date: 2017-12-12
SHANDONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] In summary, the main reasons restricting the application of existing hepatitis B vaccines include: first, the number of immunizations with aluminum adjuvant vaccines is too high, which takes a long time, which limits the full implementation of vaccination; second, the immune memory time of aluminum adjuvant vaccines is short, and with As time goes by, the acquired immunity of hepatitis B will weaken; third, the aluminum adjuvant vaccine can only induce humoral immunity, and a small number of people cannot produce enough antibodies to prevent HBV infection; fourth, aluminum compounds as adjuvants may cause various adverse reactions, affecting the vaccinated population medication safety

Method used

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  • Adjuvant-free single-dose HBsAg nanogel vaccine and preparation method thereof
  • Adjuvant-free single-dose HBsAg nanogel vaccine and preparation method thereof
  • Adjuvant-free single-dose HBsAg nanogel vaccine and preparation method thereof

Examples

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Effect test

Embodiment 1

[0045] Example 1: Preparation of a single-dose HBsAg nanogel vaccine without an adjuvant with a positive charge on the surface

[0046] The specific preparation method is as follows:

[0047] CS solution (2mg / ml, pH=6), was added dropwise into HBsAg solution (25μg / ml) under stirring, after the stirring was stable, was added dropwise into γ-PGA solution (0.5mg / ml), stirred at 40°C for 20 minutes, that is A single-dose HBsAg nanogel vaccine (HBsAg Ng(+)) without adjuvant was prepared.

Embodiment 2

[0048] Example 2: Preparation of adjuvant-free single-dose HBsAg nanogel vaccine with negative charges on the surface

[0049] The specific preparation method is as follows:

[0050] γ-PGA solution (2mg / ml), was added dropwise to HBsAg solution (25μg / ml) under stirring, and after the stirring was stable, was added dropwise to CS solution (0.5mg / ml, pH=6), stirred at 40°C for 20 minutes, that is A single-dose HBsAg nanogel vaccine (HBsAg Ng(-)) without adjuvant was prepared.

[0051] The physical and chemical properties of the non-adjuvanted single-dose HBsAg nanogel vaccine prepared in Example 1 and Example 2 were investigated:

[0052] The particle size and Zeta potential were measured by a nanoparticle size analyzer (Zetasizer NanoZS90) produced by Malvern Instruments, UK. Morphology by JEM-100CXII transmission electron microscope (Jeol Corporation, Japan). The encapsulation efficiency of HBsAg was indirectly measured by centrifuging (40000×g, 20min) and measuring the fre...

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Abstract

The invention discloses an adjuvant-free single-dose HBsAg nanogel vaccine and a preparation method thereof. The preparation method of the adjuvant-free single-dose HBsAg nanogel vaccine comprises the following step: under a constant-temperature stirring condition, mixing CS, HBsAg and a gamma-PGA solution step by step to prepare the positive-charge or negative-charge adjuvant-free single-dose HBsAg nanogel vaccine. The positive-charge HBsAg nanogel vaccine can obtain effective antibody expression only by single-dose injection, so that the immunity of cells is enhanced, the compliance of a vaccinator can be better improved, and general implementation of HBV prevention is guaranteed. The adjuvant-free single-dose HBsAg nanogel vaccine can induce formation of immunological memory to perform long-acting immunity protection on the vaccinator. The negative-charge HBsAg nanogel vaccine has no obvious generation of antibodies through single-dose injection, but when applied in combination with the positive-charge HBsAg nanogel vaccine, can obtain stronger cell immunity, and can better perform long-acting immunity protection on HBV.

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to a novel adjuvant-free single-dose HBsAg nanogel vaccine and a preparation method thereof. Background technique [0002] According to recent statistics, about 2 billion people in the world have been infected with hepatitis B virus (HBV). Among them, more than 350 million become chronic hepatitis B virus (CHB) carriers, and they will be at risk of developing liver cirrhosis and liver cancer. About 2 million people die each year due to HBV infection. China is the hardest-hit area for chronic HBV infection, and the proportion of HBV carriers is as high as 9.3%. Therefore, the persistent virus infection caused by HBV still seriously endangers the health of our people and affects the improvement of our population quality. [0003] Preventive immunization is currently the best way to control HBV infection. Since 1982, safe and effective HBV preventive vaccines have been marketed. This va...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/29A61K9/06A61K47/36A61K47/34A61P1/16A61P31/20
CPCA61K9/0019A61K9/06A61K39/12A61K47/34A61K47/36C12N2730/10134
Inventor 张建王海刚韩秋菊徐东青赵华俊
Owner SHANDONG UNIV
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