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Recombinant herpes zoster vaccine
Herpes zoster may occur after primary infection with varicella virus, and the risk of herpes zoster increases with age and reduced immune function. Immunosuppression and aging are the susceptibility factors of herpes zoster. About one-third of people may develop herpes zoster at a certain stage in their lives. The incidence of HZ ranges from 1.2‰ to 4.8‰ each year in immunocompetent people worldwide. In the United States, the incidence of herpes zoster ranges from 3.2‰ to 4.2‰ each year, with about 1 million people affected each year. Among them, the incidence can reach 10‰ each year in people aged 60 years and above. In Europe and Japan, about 1.7 million and 600,000 people suffer from herpes zoster each year, respectively. Herpes zoster in China has not been included in the management of infectious diseases, and there are no systematic studies on the incidence level, disease burden and risk factors of herpes zoster. According to the most conservative incidence rate of 1.5‰ each year worldwide, more than 2 million people suffer from herpes zoster each year in China.
Two generations of herpes zoster vaccine products have been launched in the market worldwide. The first-generation vaccine is a conventional live attenuated vaccine, which is prepared by inoculating human diploid cells (MRC-5) with attenuated varicella-zoster virus Oka strain, culturing and harvesting the virus liquid, and adding stabilizer for lyophilization. The second-generation vaccine is a gene engineered protein vaccine, which is composed of glycoprotein E (gE) in varicella-zoster virus and adjuvant system AS01B. In clinical trials, the protection rate of the second-generation gene engineered vaccines against HZ was 96.6% in the population aged 50-59 years, and 97.9% in the population aged 70 years and above. Based on its outstanding safety and efficacy data, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention in the United States issued an opinion: (1) The gene engineered vaccines is recommended for the elderly population aged 50 years and above with normal immune function to prevent herpes zoster and its related complications; (2) the gene engineered vaccines is recommended for the adult population who has previously received the first-generation live attenuated vaccine and has normal immune function to prevent herpes zoster and its related complications; (3) the gene engineered vaccines is superior to the live attenuated vaccine in preventing herpes zoster and its related complications.
The herpes zoster vaccine project developed by RecBio includes a new generation of gene engineered subunit vaccines. At present, the project has progressed smoothly, and there have been significant breakthroughs in various critical technical difficulties.
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