CSP #403 - Trial of Varicella Zoster Vaccine for the Prevention of Herpes Zoster and Its Complications
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38,456
- 试验地点
- 43
- 主要终点
- Reduce burden of illness due to herpes zoster (HZ)
研究概览
简要总结
The incidence and severity of HZ (or shingles), as well as the frequency and severity of its complications, increases markedly with increasing age. More than half of all cases occur in persons over the age of 60. Even without complications, HZ can interfere with an elderly patient's ability to perform essential activities of daily living, resulting in a loss of independence that is emotionally devastating and frequently irreversible. The most common complication of HZ in elderly persons is postherpetic neuralgia (PHN), which frequently results in disordered sleep, chronic fatigue, anxiety and severe depression. Antiviral therapy has a modest impact on the acute phase of HZ. However, it does not appear to prevent the development of PHN.
This study is a 5.5 year randomized, double-blind, placebo-controlled, efficacy trial to determine whether vaccination with live-attenuated Oka/Merck varicella-zoster decreases the incidence and/or severity of herpes zoster (HZ) and its complications in adults 60 years of age and older.
详细描述
Primary Hypothesis:
Immunization with live, attenuated (Oka/Merck) varicella-zoster vaccine will significantly reduce the burden of illness associated with herpes zoster (HZ).
Secondary Hypotheses:
Immunization with live, attenuated (Oka/Merck) varicella-zoster vaccine will reduce the incidence of postherpetic neuralgia (PHN).
Primary Outcomes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 60 years of age and older.
- •History of Chickenpox.
- •Have given written informed consent prior to enrollment.
- •History of varicella or long-term (greater than or equal to 30 years) residence in the continental USA.
排除标准
- •No history of shingles, no current history of immune suppression (e.g. malignancy or neoplastic disease, corticosteroid therapy).
- •No immunosuppression resulting from disease (e.g., malignancy; HIV infection), corticosteroids (except intermittent topical or inhaled corticosteroid [greater than 800 mcg/day beclomethasone dipropionate or equivalent]), or other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation).
- •No active neoplastic disease (except local skin cancer or other malignancies [e.g., prostate cancer] that are stable in the absence of immunosuppressive/cytotoxic therapy).
- •No prior Herpes Zoster.
- •No prior receipt of varicella vaccine.
- •No allergic sensitivity to neomycin.
- •No history of anaphylactoid reaction to gelatin.
- •No significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 5 years).
- •Not ambulatory (must not be bed-ridden or homebound).
- •No receipt of immune globulin or any other blood product within 3 months before or planned during the 3-5 year study period.
- •No receipt of any other immunizations within one month before study vaccination (2 weeks in the case of inactivated influenza vaccines or other non-replicating immunization products [e.g., dT, pneumococcal vaccine, hepatitis A vaccine, hepatitis B vaccine]), or scheduled within 6 weeks after study vaccination.
- •Not currently receiving antiviral therapy.
- •No other condition (e.g., extensive psoriasis, chronic pain syndrome, cognitive impairment, severe hearing loss) that, in the opinion of the investigator, might interfere with the evaluations required by the study.
- •No intercurrent illness (e.g., urinary tract infection, influenza) that might interfere with the interpretation of the study.
- •No females who are pre-menopausal.
- •No subjects unlikely to adhere to protocol follow-up.
- •No subjects involved in a conflicting (vaccine or investigational drug) clinical trial.
结局指标
主要结局
Reduce burden of illness due to herpes zoster (HZ)
时间窗: Incidence of postherpetic neuralgia (PHN), where PHN is defined as HZ-associated pain greater than or equal to 3 persisting or appearing more than 30 days after the onset of the HZ rash
次要结局
未报告次要终点