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Clinical Trials associated with Zoster vaccine, Live(Shanghai Institute of Biological Products)A Safety and Immunogenicity Study of a Zoster Vaccine in Healthy Adults >= 40 Years
Varicella-zoster virus (VZV) is a herpesvirus that causes two distinct clinical syndromes.Primary infection is manifested as varicella (chickenpox), whereas reactivation of latent VZV results in a localized eruption known as herpes zoster. Most people 40 years of age or older had evidence of previous VZV infection. This study plans to have 522 adults above 40 years old involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated zoster vaccine. The investigational vaccine is produced by Shanghai Institute of Biological Products Co., Ltd. The safety and immunogenicity of the zoster vaccine is evaluated.
评估带状疱疹减毒活疫苗用于40岁及以上健康人群安全性和免疫原性的随机、盲法、对照Ⅰ期、Ⅱ期临床试验
[Translation] A randomized, blinded, controlled phase I and II clinical trial to evaluate the safety and immunogenicity of herpes zoster live attenuated vaccine in healthy people aged 40 years and above
Ⅰ期临床试验:评价40岁及以上健康人群中免疫1剂带状疱疹减毒活疫苗、试验对照后的安全性; Ⅱ期临床试验:评价带状疱疹减毒活疫苗在40岁及以上健康人群中免疫1剂后特异性抗体阳转率、GMT及GMI和免疫持久性,并评价其安全性;初步探索和评价疫苗诱导的细胞免疫应答。
[Translation] Phase I clinical trial: To evaluate the safety of immunization with one dose of live attenuated herpes zoster vaccine and experimental control in healthy people aged 40 years and above; Phase II clinical trial: To evaluate the specific antibody seroconversion rate, GMT, GMI and immune persistence of live attenuated herpes zoster vaccine in healthy people aged 40 years and above after one dose, and to evaluate its safety; To preliminarily explore and evaluate the vaccine-induced cellular immune response.
100 Clinical Results associated with Zoster vaccine, Live(Shanghai Institute of Biological Products)
100 Translational Medicine associated with Zoster vaccine, Live(Shanghai Institute of Biological Products)
100 Patents (Medical) associated with Zoster vaccine, Live(Shanghai Institute of Biological Products)
100 Deals associated with Zoster vaccine, Live(Shanghai Institute of Biological Products)