Protective Mechanisms Against a Pandemic Respiratory Virus: B-Cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 3, 2011

Stanford University0 个研究点目标入组 63 人开始时间: 2011年9月最近更新: 2017年8月21日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Stanford University
入组人数: 63
主要终点: Number of Individual Twins Who Received Influenza Vaccine

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will investigate markers, mechanisms and define general predictors for immunological health by comparing influenza vaccine responses in monozygotic and dizygotic twins.

详细描述

The investigators plan to study the response to influenza vaccines much more broadly and deeply across different age groups and with different vaccine formulations and to probe the influence of genetics on these responses using monozygotic and dizygotic twins. On an investigational basis, investigators plan to compare various immunological responses, identify age-specific biomarkers or clusters of markers, quantify the frequency of influenza-specific T-cells pre- and post-vaccination, and determine the effective breadth of T-cell repertoire to an influenza vaccine within an individual as a function of age and to what degree this is genetically determined.

Twin Groups B-E will receive a single administration of the 2011-2012 formulation of seasonal trivalent inactivated influenza vaccine (TIV). Group F, elderly monozygotic twin participants, will be randomly assigned to receive a single dose of inactivated vaccine, either the usual dose or the High-Dose TIV. Blood samples to conduct the assays described will be taken at pre-immunization, Days 7-10 and 28 post-immunization. The number of individual participants, not the number of twin pairs is being reported in all the modules.

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: 18 Years 至 100 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Otherwise healthy, ambulatory adults, ages 18-30 years (identical or fraternal twin pairs), 40-64 years (identical or fraternal twin pairs) or 65-100 years (identical twin pairs).
•Willing to complete the informed consent process.
•Availability for follow-up for the planned duration of the study at least 28 days after immunization.
•Acceptable medical history and vital signs.

排除标准

•Prior off-study vaccination with trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV) in Fall 2011
•Allergy to egg or egg products, or to vaccine components, including thimerosal (if TIV multidose vials used)
•Allergy to latex (for Group F only - may be assigned to Fluzone High-Dose). Review with investigator.
•Life-threatening reactions to previous influenza vaccinations
•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, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
•Blood pressure >150 systolic or > 95 diastolic at Visit 1
•Hospitalization in the past year for congestive heart failure or emphysema.
•Chronic Hepatitis B or C
•Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays, topical steroids and inhaled 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 aspirin up to 325 mg.day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety.
•Receipt of blood or blood products within the past 6 months
•Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
•Inactivated vaccine 14 days prior to vaccination
•Live, attenuated vaccine within 60 days of vaccination
•History of Guillain-Barre Syndrome
•Pregnant or lactating woman
•Use of investigational agents within 30 days prior to enrollment
•Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
•Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.