Herpes zoster vaccine composition as well as preparation method and application thereof

Abstract

The invention discloses a herpes zoster vaccine composition as well as a preparation method and application thereof, and belongs to the field of vaccines. The vaccine composition comprises varicella-zoster glycoprotein E, a polylactic acid-polyglycolic acid copolymer (PLGA), a double-stranded polycytosine nucleotide fragment (Poly I: C) and a GC-rich single-stranded oligodeoxynucleotide fragment (CpG ODN), the particles with the diameter of 20-400 nanometers are prepared through microfluidic equipment or a double-emulsifying-medium evaporation method. The vaccine composition can specifically enhance humoral immune response and cellular immune response to varicella-zoster glycoprotein E, and can be used as a herpes zoster vaccine; and the components in the vaccine composition are cheap andeasily available, so that the vaccine cost is effectively reduced, and the vaccine yield is increased.

Description

technical field [0001] The invention belongs to the field of vaccines, in particular to a herpes zoster vaccine composition and its preparation method and application. Background technique [0002] Almost all children have been infected with varicella-zoster virus (Varicella-zostervirus, VZV) before they grow up. The first infection produces chickenpox, and the virus is latent in the ganglion after the chickenpox self-healing. Cellular immunity caused by aging or other reasons A weakened response (eg, HIV infection or immunosuppression) induces viral reactivation in the body, leading to the development of shingles. [0003] The protection rates of Merk attenuated vaccine Zostavax to people aged 50-59, 60-69 and over 70 are about 70%, 64% and 38% respectively. This decline in protection with age is largely attributable to the weakened cellular immune response that accompanies aging of the immune system. In addition, compared with the preparation of low-titer varicella vacci...

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Problems solved by technology

The key component of AS01B, QS21, is a polysaccharide mixture that can only be extracted from the saponin of the South American saponaria tree Quillaja saponaria by reverse-phase high-performance liquid chromatography. per person (consistent with its 2018 sales volume) and Chile, the main producing country, has begun to restrict the harvesting of related saponins), the quality control of the preparation process is difficult (the purified components are non-monomers with complex components, and the active ingredients are sensitive to temperature ), serious limitations such as the need to add detoxification agents due to hemolytic activity

In addition, according to the instructions of Shingrix, the adjuvant component AS01B needs to be temporarily mixed with the antigen before use (Bedsidemix), indirectly suggesting that the stability of the liposome adjuvant system needs to be further improved when used in vaccines

[0005] The above background makes the herpes zoster subunit vaccine expensive (150-200 US dollars / injection), but the supply is still in short supply (93.3% of the vaccines were sold in the United States in 2018, and there are basically no markets outside the United States at present)

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