Effects of Persistent Innate Immune Activation on Vaccine Efficacy Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction).
研究概览
简要总结
Vaccines have been responsible for preventing millions of deaths and extending the average human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes and associated functions that bring about protective immunity.This study aims to define cellular functions and genes important for the hepatitis B (HBV) vaccine immune response in healthy individuals. The investigators hypothesize that many genes associated with innate and adaptive immune functions are important for an effective HBV vaccine response.
详细描述
Vaccines have been responsible for preventing millions of deaths and extending the average human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes and associated functions that bring about protective immunity. Knowledge of those genes and cellular functions activated by effective vaccination can improve our understanding of how the immune system works and define the features necessary for a successful vaccine response. This study aims to define cellular functions important for the hepatitis B (HBV) vaccine immune response in healthy individuals. The investigators will identify those genes that are activated or suppressed in immune cells at various times after each dose of the HBV vaccine. The investigators will explore these vaccine-induced "gene signatures" to characterize the cellular functions associated with an effective immune response to HBV vaccination. The investigators hypothesize that many genes associated with innate and adaptive immune functions are important for an effective HBV vaccine response.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer without significant medical problems
- •Willing to receive three doses of an FDA-approved Hepatitis B vaccine
排除标准
- •Male or female < 18 and > 60 years of age
- •Received any vaccine within a month prior to study vaccine
- •History of Hepatitis B infection
- •History of previous Hepatitis B vaccination(s)
- •History of Hepatitis C virus (HCV) infection or positive HCV antibody test
- •Participation in another clinical study of an investigational product currently or within the past 90 days, or expected participation during this study
- •Positive serum antibody against Hep B surface antigen and/or core Hep B core antigen
- •human immunodeficiency virus (HIV) positive
- •In the opinion of the investigator, the volunteer is unlikely to comply with the study protocol
- •Any clinically significant abnormality or medical history or physical examination including history of immunodeficiency or autoimmune disease
- •Is pregnant or lactating
- •Currently taking systemic steroids or other immunomodulatory medications including anticancer medications and antiviral medications
- •Any clinically significant acute or chronic medical condition requiring care by a primary care provider (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the investigator, would preclude participation
- •Unable to continue participation for 30 weeks
研究组 & 干预措施
Hepatitis B vaccination
All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).
干预措施: Hepatitis B Vaccine (Recombinant) (Biological)
结局指标
主要结局
Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction).
时间窗: Day 1, Day 3, Week 1, and Week 2
Number of differentially expressed genes at time point versus prevaccination baseline (p\<0.05). Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses. Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.
Number of Significantly Differentially Expressed Genes at False Discovery Rate (FDR)< 0.05 (Upon Correction for Multiple Testing).
时间窗: Day 1, Day 3, Week 1, and Week 2
Number of significantly differentially expressed genes at time point versus prevaccination baseline (FDR\<0.05). Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses. Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.
次要结局
未报告次要终点
研究者
Brad Rosenberg
Whitehead Presidential Fellow
Rockefeller University