Immune Response to Shingles Vaccination
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood
研究概览
简要总结
The purpose of this study is to learn more about the immune response to varicella zoster virus (VZV).
详细描述
Participants 70 years of age or older will receive the FDA-approved shingles vaccine (Zostavax). Blood samples and optional skin biopsies will be obtained before and after vaccination to study the immune responses to shingles vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •70 years of age or older.
- •History of chickenpox.
- •Exclusion Criteria
- •Previous vaccination with Zostavax or with the chickenpox vaccine.
- •History of ever having had shingles.
- •Been in close contact with a person who had chickenpox or shingles in the past 5 years.
- •VZV seronegative
- •Taking systemic suppressive regular doses of drugs with anti-VZV activity such as acyclovir, famciclovir, or valacyclovir. Episodic use is allowed. For Cohort 1: medication cannot be taken 24 hours prior to or 30 days after receiving Zostavax per CDC recommendations.
- •HIV seropositive.
- •Hepatitis C infection or active Hepatitis B infection.
- •History of a life-threatening allergic reaction (anaphylactic/anaphylactoid reaction) to gelatin, neomycin, or any other component of shingles vaccine. Neomycin allergy manifested as contact dermatitis is not an exclusion.
- •Has immunosuppression as a result of an underlying illness (e.g. leukemia, lymphoma or other malignant neoplasms) or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy.
- •Has long-term use of oral or parenteral steroids (>7 days), or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
- •Women of child-bearing potential only: pregnant or planning to become pregnant 3 months post vaccination
- •Donated blood in the past 8 weeks or planning to donate blood during the study
- •Weighs less than 110 lbs
- •Has any condition or medical history that would, in the opinion of the site principal investigator place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- •Additional exclusions for optional skin biopsy:
- •Has an acute or chronic medical condition that, in the opinion of the investigator, would render biopsies unsafe
- •History of coagulopathy or taking medication that may cause bleeding (long term aspirin, heparin, coumadin)
- •History of keloid formation or excessive scarring
- •History of frequent cellulitis or boils (>3 episodes in past 2 years) requiring antibiotic therapy.
- •Allergy to lidocaine, silver nitrate, or mupirocin.
排除标准
- 未提供
研究组 & 干预措施
10 persons over 70 years of age that received Zostavax
10 persons over 70 years of age that received Zostavax (single 0.65-mL dose subcutaneously in the deltoid region of the upper arm)
干预措施: Zoster Vaccine Live (Drug)
结局指标
主要结局
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood
时间窗: 6 months
To determine if Zostavax, when given as FDA indicated, boosts VZV-specific T-cells in the blood
Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin
时间窗: 4 weeks
To determine if shingles disease boosts the local level of VZV-specific T cells in skin 4 weeks after Zostavax
次要结局
- Number of Participants With Adverse Events Due to Zostavax(6 months)
研究者
Christine Johnston
Associate Professor
University of Washington