NCT03898973撤回4 期
Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- HAI titer
研究概览
简要总结
This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to determine how immune memory develops at the actual site of exposure, and how immunization may alter this process.
详细描述
This is a Phase IV study of licensed influenza vaccines with up to 50 volunteers, 20-75 years of age.
Each volunteer will participate for approximately 1 week including enrollment, vaccination, and completion of sample collection.
The study has a total of 3 visits.
Study Procedures:
Screening Visit: Procedures during this visit are: Informed consent process, assess eligibility collect relevant clinical data and obtain 10 mL of blood to ensure the FNA will be safe (acceptable CBC and PT/PTT).
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20-75-year-old male and female patients
- •Body mass index (BMI) 20-35 kg/m2
- •Acceptable laboratory values: Absolute neutrophil count (ANC) > 750 cells/mm3; Hemoglobin >10 g/dL; Platelet count >75,000/mm3; Partial thromboplastin time (PTT) >1.2x ULN; Prothrombin time (PT) >1.2x ULN
- •Willing and able to complete the informed consent process
- •Availability for follow-up for the planned duration of the study
- •Acceptable medical history by review of inclusion/exclusion criteria
排除标准
- •Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination
- •Life-threatening reactions to previous influenza vaccinations
- •Allergy to egg or egg products or to vaccine components
- •Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- •History of immunodeficiency (including HIV infection)
- •Known or suspected impairment of immunologic function; may include significant liver disease, diabetes mellitus treated with insulin or moderate to severe renal disease
- •Chronic Hepatitis B or C.
- •Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible). Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
- •Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
- •Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator might jeopardize volunteer safety or compliance with the protocol.
- •History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
- •Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg per day), Plavix, or Aggrenox will be reviewed by investigators to determine if study participation would affect the volunteer's safety or compliance with the protocol.
- •Receipt of blood or blood products within the past 6 months or planned used during the study.
- •A medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
- •Receipt of an inactivated vaccine 14 days prior to study enrollment, or planned vaccinations prior to completion of last annual study visit (~ 28 days after study vaccination)
- •Receipt of a live, attenuated vaccine within 60 days prior to enrollment of planned vaccination prior to completion of last study visit (~ 28 days after study enrollment)
- •Need for allergy immunization (that cannot be postponed) until after the last study visit.
- •History of Guillain-Barre# syndrome
- •Use of investigational agents within 30 days prior to enrollment or planned use during the study.
- •Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or donation of platelets within 2 weeks of enrollment or planned donation prior to completion of the last visit.
- •Any condition which, in the opinion of the investigator, might interfere with volunteer safety,
结局指标
主要结局
HAI titer
时间窗: Day 7 after vaccination
This measures response to influenza vaccine
次要结局
未报告次要终点
研究者
Philip Grant
Assistant Professor of Medicine (Infectious Diseases)
Stanford University
研究点 (2)
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