一项采用多中心、 双盲、 安慰剂对照设计,用于评价在 40岁及以上人群中
按种重组带状疱疹疫苗 (CHo细胞)保护效力持久性的 ⅡIb期临床试验
[Translation] A phase IIb clinical trial using a multicenter, double-blind, placebo-controlled design to evaluate the durability of protective efficacy of a recombinant herpes zoster vaccine (CHo cell) in people aged 40 years and above
1.与安慰剂 比较,评价重组带状疱疹疫苗 (CHo细胞 )在>40岁 人群 中全程免疫后13~36个 月预防带状疱疹的保护效力 (VaccineEff1cacy,VE)。
2.与安慰剂 比较,评价重组带状疱疹疫苗 (CHo细 胞)在≥40岁 人群中全程免疫后13~36个 月预防 HZ实验室确诊病例的保护效力。
[Translation] 1. To evaluate the protective efficacy of recombinant herpes zoster vaccine (CHo cells) in preventing herpes zoster (HZ) in people aged >40 years 13-36 months after full immunization compared with placebo (Vaccine Efficacy, VE).
2. To evaluate the protective efficacy of recombinant herpes zoster vaccine (CHo cells) in preventing HZ laboratory confirmed cases in people aged ≥40 years 13-36 months after full immunization compared with placebo.
/ Active, not recruitingPhase 2 基于多组学的重组带状疱疹疫苗(CHO 细胞)免疫应答保护机制临床研究
[Translation] Clinical study on the immune response protection mechanism of recombinant herpes zoster vaccine (CHO cells) based on multi-omics
(1)全景式揭示重组HZ疫苗先天免疫和适应性免疫应答规律,阐明重组HZ疫苗先天免疫和适应性免疫应答间的调控作用机制。
(2)确定精准预测HZ疫苗保护性免疫反应的早期先天免疫标志物,实现疫苗保护性免疫的早期精准预测与评价。
[Translation] (1) Panoramic reveal of the innate and adaptive immune response patterns of recombinant HZ vaccine, and clarify the regulatory mechanism between the innate and adaptive immune responses of recombinant HZ vaccine.
(2) Determine the early innate immune markers that can accurately predict the protective immune response of HZ vaccine, and achieve early and accurate prediction and evaluation of vaccine protective immunity.
/ Active, not recruitingNot Applicable 一项采用随机、盲法设计,评估重组带状疱疹疫苗(CHO细胞)LZ901对比同类阳性疫苗在50岁及以上人群中免疫原性和安全性的临床试验
[Translation] A randomized, blinded clinical trial to evaluate the immunogenicity and safety of the recombinant herpes zoster vaccine (CHO cells) LZ901 compared with similar positive vaccines in people aged 50 years and above
与对照疫苗比较,评价重组带状疱疹疫苗(CHO细胞)LZ901在50岁以及上人群中诱生细胞免疫的免疫原性。
[Translation] To evaluate the immunogenicity of recombinant herpes zoster vaccine (CHO cells) LZ901 in inducing cellular immunity in people aged 50 years and above, compared with a control vaccine.
100 Clinical Results associated with Green Bamboo Biopharmaceutical (Zhuhai) Co., Ltd.
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100 Translational Medicine associated with Green Bamboo Biopharmaceutical (Zhuhai) Co., Ltd.