A Phase 1 Randomized, Subject-Blinded, Active-Controlled, Dose Escalation, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers Between the Ages of 50 and 69 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Number of AEs (Adverse Events)
研究概览
简要总结
This is a randomized, active-controlled, dose-escalation multi-center study of 2 doses (Day 1 and Week 8) of an investigational herpes zoster (HZ) vaccine (Z-1018), combining herpes zoster antigen- (gE) with a Toll-like receptor 9 (TLR9) agonist adjuvant (CpG 1018) with and without alum in approximately 150 healthy volunteers 50 to 69 years of age (inclusive).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 50 to 69 years of age
- •Be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
- •Must be able to comprehend and follow all required study procedures and be available for all visits scheduled in the study
- •Seronegative for human immunodeficiency virus (HIV)
排除标准
- •History of HZ
- •Previous vaccination against varicella or HZ
- •If female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy
- •Known history of HIV (HIV 1/2 antibodies)
- •Has a history of sensitivity to any component of study vaccines
- •Has received any blood products or immunoglobulin within 90 days prior to study injection, or is likely to require infusion of blood products during the study period
- •Has received the following prior to the first injection:
- •14 days: any non-live vaccine
- •Any live vaccine, including a COVID-19 vaccine
- •Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids
- •Granulocyte or granulocyte-macrophage colony-stimulating factor
- •Any other investigational medicinal agent, including a COVID-19 vaccine
- •Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose
- •Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous cell or basal cell carcinoma of the skin
- •History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- •History of autoimmune disease
研究组 & 干预措施
Z-1018 Dose Level 2a
100 mcg gE + 6000 mcg CpG 1018 + alum
干预措施: Z-1018 (Biological)
Shingrix
干预措施: Shingrix (Biological)
Z-1018 Dose Level 2
100 mcg gE + 6000 mcg CpG 1018
干预措施: Z-1018 (Biological)
Z-1018 Dose Level 1a
100 mcg gE + 3000 mcg CpG 1018 + alum
干预措施: Z-1018 (Biological)
Z-1018 Dose Level 1
100 mcg gE + 3000 mcg CpG 1018
干预措施: Z-1018 (Biological)
结局指标
主要结局
Number of AEs (Adverse Events)
时间窗: Day 1 through week 20
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine
时间窗: Day 1 to day 7
Number of SAEs (Serious Adverse Events)
时间窗: Through week 20
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine.
时间窗: Day 57 to day 63
次要结局
- Measure Geometric mean concentration (GMC) of IgG antibodies to varicella-zoster virus (VZV) antigen glycoprotein E (gE)(At week 12)
- Response rate of vaccine(At week 12)
- Frequency of CD4+ T cells(At week 12)