NCT07753265尚未招募1 期
A Study on the Live-Attenuated Herpes Zoster Vaccine for Sequential Booster Immunization Following Recombinant Herpes Zoster Vaccine
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- immunogenicity
研究概览
简要总结
Evaluate the immunogenicity after boost vaccination with the live attenuated herpes zoster vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 50 years old;
- •The participant can provide personal informed consent and sign the informed consent form;
- •temperature ≤ 37.0℃ on the day of administration;
- •capable of complying with the requirements of the clinical trial protocol to complete the trial.
排除标准
- •Subjects with immunodeficiency or immunosuppression caused by underlying diseases or treatments, including primary/acquired immunodeficiency (e.g., AIDS and other virus-induced immunodeficiency), hematologic malignancies (leukemia, lymphoma or other bone marrow/lymphoid neoplasms), ongoing immunosuppressive therapy, or radiotherapy/chemotherapy for malignancies.
- •Subjects with a history of allergic reaction to any component of the investigational product.
- •Subjects with acute infection or acute exacerbation of chronic infection (vaccination should be deferred).
- •Women of non-postmenopausal status with positive pregnancy test, pregnant or lactating women, or those planning pregnancy within 6 months.
- •Subjects with prior history of herpes zoster.
- •Subjects with prior receipt of varicella or herpes zoster vaccine.
- •Receipt of live-attenuated vaccines within 14 days, or subunit/inactivated vaccines within 7 days prior to study vaccination.
- •Receipt of whole-blood, plasma or immunoglobulin within 5 months before, or within 3 weeks after study vaccination.
- •Receipt of investigational drugs from other clinical trials within 1 month before study vaccination, current participation in another clinical trial, or planned use of investigational agents during study period.
- •Current or planned use of salicylates (including aspirin, diflunisal, etc.).
- •Uncontrolled abnormal blood pressure at screening (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg despite medication).
- •Subjects meeting contraindications or precautions specified in the product's prescribing information.
- •Any condition that, in the Investigator's opinion, may interfere with study evaluations.
研究组 & 干预措施
live-attenuated zoster vaccine
Experimental
live-attenuated zoster vaccine
干预措施: live-attenuated zoster vaccine (Biological)
结局指标
主要结局
immunogenicity
时间窗: 30 days after administration
IgG to gE/FAMA antibody/Cellular immune level
次要结局
未报告次要终点
研究者
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