EUCTR2014-001924-31-GB进行中(未招募)1 期
Exploring novel mechanisms of vaccine failure and induction of pulmonary immunity following live attenuated influenza vaccination in HIV infected and uninfected individuals: a pilot study. - LAIV-HIV
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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 clinical trial of medicinal product
入排标准
入选标准
- •antiretroviral therapy
- •count of >200/mm3 (for at least 6 months, last available measurement within 3 months)
- •load undetectable (for at least 6 months, last available measurement within 3 months)
- •of having received at least one dose of trivalent inactivated influenza vaccine in the past
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •egg allergy
- •Hypersensitivity
- •to gentamicin
- •or breastfeeding
- •lung disease (e.g. bronchiectasis)
- •history of severe asthma or current active wheezing
- •cause for immunosuppression (e.g. malignancy) or immunosuppressive
- •B or C coinfection
- •(as defined by a detectable HBSAg or HCV RNA)
- •close contact with severely immunocompromised individuals in 2 weeks
- •following LAIV (e.g bone marrow transplant recipients)
- •of any other vaccination within the last 4 weeks
- •Individuals
- •who have had a febrile illness or other symptoms of acute infectious
- •illness (respiratory, enteric or soft tissue) within the last 2 weeks.
- •Individuals
- •with a known and current history of anaemia or any symptoms
- •(shortness of breath, chronic fatigue, chest pain or pallor) suggestive of
- •possible anaemia or haemoglobin below the lower limit of sex adjusted normal
- •range on a full blood count taken within the last 3 months.
- •(active) participation in any clinical trial
- •to communicate in English or convey willingness to participate
研究者
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