Persistence of Protection Conferred by Shingrix Against Herpes Zoster
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Magnitude of Varicella-Zoster Virus (VZV) DNAemia
研究概览
简要总结
The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people. Two vaccines are currently approved by the Food and Drug Administration (FDA) to prevent shingles. Zostavax is a live virus vaccine which has been available since 2006 and prevents shingles about 50% of the time, though it is less effective the older a person is when they receive it. Shingrix, which was approved by the FDA in 2017, is not a live virus, but has an additive in the vaccine to boost immune response. It is about 97% effective at preventing shingles regardless of a person's age and so far has been effective for at least 4 years after vaccination. Because Zostavax has live virus in it, giving a "challenge" dose of Zostavax - vOka varicella zoster virus - to people who have received both vaccines (Zostavax or Shingrix) in the past, will allow researchers to learn more about how the body works to prevent shingles and how any shingles vaccination helps protect against shingles.
详细描述
The primary endpoint of this study was the area under the concentration/time curve of quantitative VZV DNA in plasma. However, all the VZV DNA measurements were below the lower limit of quantitation of the assay. Due to this unexpected outcome, we performed a qualitative analysis of presence or absence of VZV DNA in plasma at Day ≥3 after the vOka challenge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 50-85
- •General good health
- •Women of non-childbearing potential must be postmenopausal or have undergone hysterectomy or bilateral oophorectomy
- •ARM 1 ONLY: Documented evidence of immunization with ZVL or SRX at least 5 years previously
- •ARM 2 ONLY; Documented evidence of immunization with ZVL 6-12 months prior to enrollment
- •ARM 3 ONLY: Have never received any shingles vaccination
排除标准
- •Prior history of herpes zoster (HZ)
- •Blood products received in the 3 months prior to study enrollment or planned for the subsequent week for Arm 1; Arm 2 requires same exclusion; Arm 3 extends the exclusion to the week after the vOka challenge, which is 6 months after completing SRX administration.
- •Significant immune suppressive illness or therapy
- •Concomitant vaccine received within 2 (inactive) or 4 (live) weeks prior to the study or during the first week of the study.
- •Women of childbearing potential.
- •Pregnancy or breastfeeding.
- •Participation in a concurrent clinical study in which the subject will be exposed to and investigational product during the period starting 7 days before the first dose of study vaccine through the completion of the study.
研究组 & 干预措施
ZVL >5 years previously
Participants have received Zostavax (ZVL) at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.
干预措施: Zostavax (Biological)
ZVL 6-12 months previously
Participants who received ZVL 6-12 months previously will be administered an intradermal dose of vOka varicella zoster virus (ZVL) in non-dominant deltoid.
干预措施: Zostavax (Biological)
No previous ZVL
Participants who've never received a shingles vaccine will be given the 2 standard doses of RZV. Six months later they will be given the intradermal dose of vOka varicella zoster virus (ZVL) in the non-dominant deltoid.
干预措施: Zostavax (Biological)
No previous ZVL
Participants who've never received a shingles vaccine will be given the 2 standard doses of RZV. Six months later they will be given the intradermal dose of vOka varicella zoster virus (ZVL) in the non-dominant deltoid.
干预措施: Shingrix (Biological)
SRX >5 years previously
Participants have received Shingrix at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.
干预措施: Zostavax (Biological)
结局指标
主要结局
Magnitude of Varicella-Zoster Virus (VZV) DNAemia
时间窗: Until VZV DNA is undetectable in the blood, measured up to Day 7
Varicella-Zoster Virus (VZV) DNAemia will be measured by polymerase chain reaction (PCR) as a surrogate for viremia over the first 7 days after vOka intradermal (ID) challenge. The outcome measure will be the area under the concentration time curve of the VZV DNAemia expressed in DNA copies/ml of blood.
次要结局
未报告次要终点