ISRCTN13657999进行中（未招募）未知
An experimental medicine study of seasonal influenza vaccination responses in Lymph nodE single-cell Genomics in AnCestrY (LEGACY01)
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy adults aged =18 years and =55 years on the day of screening
- •2. Willing and able to provide written informed consent
- •3. Identifies as having African or Asian ancestry
- •4. Usually resident in the UK for =5 years prior to screening
- •5. Not pregnant on the day of screening and willing to use a highly effective form of contraception until 12 weeks after the study immunisation, if a person of childbearing potential
- •6. Willing to avoid all other vaccines within 4 weeks either side of the study injection and fine needle aspiration
- •7. Willing and able to comply with the visit schedule and provide samples
- •8. Willing to grant authorised persons access to their trial related medical record and GP records either directly or indirectly
排除标准
- •1. Pregnant or lactating
- •2. Has a significant clinical history, physical finding on clinical examination or laboratory finding during screening, or presence of a disease that is active or requires treatment to control it, including cardiac, respiratory, endocrine, metabolic, autoimmune, liver, neurological, oncological, psychiatric, immunosuppressive/immunodeficient or other disorders which in the opinion of the investigator is not compatible with healthy status, may compromise the volunteer’s safety, preclude vaccination or tissue sampling or compromise interpretation of the immune response to vaccine. Individuals with mild/moderate, well-controlled comorbidities are allowed.
- •3. Body mass index (BMI) of =30
- •4. History of anaphylaxis or angioedema
- •5. History of severe or multiple allergies to drugs or pharmaceutical agents or contraindicated from receiving influenza vaccine or local anaesthetic including lidocaine.
- •6. History of severe local or general reaction to vaccination defined as:
- •6.1. Local:
- •6.1.1. Extensive, indurated redness and swelling involving most of the arm
- •6.1.2. Not resolving within 72 h
- •6.2. General:
- •6.2.1. Fever =39.5 °C within 48 h
- •6.2.2. Bronchospasm
- •6.2.3. Laryngeal oedema
- •6.2.4. Collapse
- •6.2.5. Convulsions or encephalopathy within 72 h
- •7. Receipt of any immunosuppressive agents within 18 weeks of screening by any route other than topical
- •8. Prescribed regular blood thinning medication likely to induce bruising or bleeding on fine needle aspiration
- •9. Detection of antibodies to hepatitis C
- •10. Detection of antibodies to HIV
- •11. Detection of anti-hepatitis B core antibodies
- •12. Participating in a clinical trial with an investigational drug or device or treated with an investigational drug within 28 days of screening
研究者
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