NCT07386509终止1 期
WU 345: Immune Responses to Adjuvanted and Non-adjuvanted Seasonal Influenza
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Comparison of antibody titers at Day 28 versus baseline
研究概览
简要总结
Healthy adults (18-49 years of age) with no previous influenza virus vaccination history for at least three years prior to enrollment will be recruited to participate in this study. All subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly in opposite deltoid muscles. Blood samples collected at 9 visits (screening, baseline, days 7, 14, 28, 60, 90, 120 and 180, fine needle aspiration (FNAs) from axillary lymph nodes from both axillae at baseline, days 7, 14, 28, 60, 90, 120 and 180.
详细描述
Healthy adults (18-49 years of age) with no previous influenza virus vaccination history for at least three years prior to enrollment will be recruited to participate in this study. All subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly in opposite deltoid muscles. Blood samples collected at 9 visits (screening, baseline, days 7, 14, 28, 60, 90, 120 and 180, fine needle aspiration (FNAs) from axillary lymph nodes from both axillae at baseline, days 7, 14, 28, 60, 90, 120 and 180.
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 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Healthy subjects aged 18-49 years.
- •Able to understand and give informed consent.
- •Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods* for 28 days before and 28 days after rabies vaccination.
- •Women of child-bearing potential using licensed hormonal methods must also use a second form of contraception.
- •4. Are in good health, as determined by medical history and targeted physical exam related to this history.
- •5. Willing to give FNA specimens for the study.
- •6. The following laboratory values obtained within 14 days prior to entry by any US laboratory that has a CLIA certification or its equivalent.
- •Absolute neutrophil count (ANC) ≥750 cells/mm3
- •Hemoglobin ≥11.0 g/dL for men and ≥10.0 g/dL for women
- •Platelet count ≥100,000/mm3
- •Creatinine clearance ≥60 mL/min estimated by the Cockcroft-Gault equation
- •NOTE: A program for calculating creatinine clearance by the Cockcroft-Gault method is available on www.fstrf.org
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (SGPT) ≤5.0 times upper limit of normal (ULN)
- •Erythrocyte sedimentation rate (ESR) within normal range
排除标准
- •1. Receipt of the following:
- •Receipt of blood products 3 months prior to vaccination or expected receipt through 12 months after vaccination.
- •Receipt of any live virus vaccines within 28 days prior to vaccination or expected receipt within 28 days after vaccination. *
- •Receipt of any inactivated vaccine within 14 days or expected receipt within 14 days after vaccination other than study vaccine. *
- •Presence of co-morbidities or immunosuppressive states such as: Chronic medical problems including (but not limited to) insulin dependent diabetes, severe heart disease (including arrhythmias), severe lung disease, auto immune diseases, thrombocytopenia and any other severe medical conditions.
- •3. Alcohol abuse, drug abuse, or psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data.
- •4. Any history of lymphoma involving axillary nodes or any history of breast cancer.
- •5. Impaired immune function or known chronic infections including, but not limited to, known HIV, tuberculosis, hepatitis B or C; organ transplantation (bone marrow, hematopoietic stem cell, or solid organ transplant); immunosuppression due to cancer; current and/or expected receipt of chemotherapy, radiation therapy, steroids** (i.e., more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 90 days , or high dose inhaled corticosteroids***); and any other immunosuppressive therapies (including anti-TNF therapy), functional or anatomic asplenia, or congenital immunodeficiency.
- •6. Pregnancy or breast feeding
- •Conditions that could affect the safety of the volunteers, such as:
- •Severe reactions to prior vaccinations, including anaphylaxis
- •History of Guillain-Barré syndrome
- •History of bleeding disorders or current use of warfarin, aspirin, heparin, nonsteroidal anti-inflammatory drugs (NSAIDs) or other blood thinner/anticoagulant medications in the past week
- •Any allergy to any component of the vaccine or lidocaine
- •Subjects with any acute illness, including any fever (> 100.4 F [>38.0C], regardless of the route) within 3 days prior to vaccination *.
- •9. Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.
- •10. ESR>30 mm/hour.
- •Previously received the 2019-2020 influenza vaccine.
- •Bilateral inflammatory process of upper arms in the past 2 weeks.
- •Prior breast or axillary biopsy and/or surgery.
- •An individual who initially is excluded from study participation based on one or more of the time-limited exclusion criteria (e.g., acute illness, receipt or expected receipt of live or inactivated vaccines) may be reconsidered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria.
- •Subjects receiving > 20 mg/day of prednisone or its equivalent daily or on alternate days for more than 2 weeks may enter the study after therapy has been discontinued for more than 3 months.
- •Subjects are excluded if on high dose intranasal steroids defined as > 960 mcg/day of beclomethasone dipropionate or equivalent.
研究组 & 干预措施
Single dose of both Fluad® and Afluria®
Experimental
All subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly
干预措施: Fluad® and Afluria® vaccination (Drug)
结局指标
主要结局
Comparison of antibody titers at Day 28 versus baseline
时间窗: Baseline and Day 28
次要结局
- Frequency, severity, and causality of all adverse events.(Baseline and Day 28)
研究者
研究点 (1)
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