2024-513933-18-00招募中4 期
(The Lion Trial) LAIV induced Immune respOnse in the Nasopharynx
Leids Universitair Medisch Centrum (LUMC)1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年7月24日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Presence or absence of viral shedding of vaccine-strains after first and second dose of LAIV in nasal lining fluid, collected using nasosorptions and analyzed with RT-qPCR.
研究概览
简要总结
Identifying mucosal surrogates of protection following intranasal LAIV in children. Shedding of the LAIV is used as a surrogate for susceptibility to infection, with the expectation that the first dose of LAIV induces variable levels of immunity that confer protection against shedding of the second dose.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Age between two and seven years old
- •Parents ability and willingness to adhere to protocol-specified procedures, including availability of a freezer at home to store samples. Donating blood is optional as this is a secondary endpoint.
排除标准
- •Recipient of any influenza vaccine (both LAIV or IIV) in the same or a previous flu-season.
- •Recipient of any other vaccine within one month prior to inclusion-date.
- •Meeting one or more contraindications for the Fluenz vaccine as stated in paragraph 6.3 of the protocol.
- •Substantial language barrier of either potential subject or parent. Participants and their parents are asked to self-collect samples during this trial, therefore instructions need be given and adequately understood.
结局指标
主要结局
Presence or absence of viral shedding of vaccine-strains after first and second dose of LAIV in nasal lining fluid, collected using nasosorptions and analyzed with RT-qPCR.
Presence or absence of viral shedding of vaccine-strains after first and second dose of LAIV in nasal lining fluid, collected using nasosorptions and analyzed with RT-qPCR.
次要结局
- LAIV shedding kinetics (density and duration) during first and second dose of LAIV, measured in nasal lining fluid using nasosorptions and analyzed with RT-qPCR.
- Change in influenza specific mucosal antibodies (including IgA) in nasal lining fluid before and after first and second dose of LAIV. Measured in nasal lining fluid from nasosorptions and analyzed for binding and/or functional capacity.
- Nasal immune responses during LAIV, with soluble proteins measured in nasal lining fluid from nasosorption samples.
- Nasal colonization and infection dynamics by other URT bacteria and viruses, comparing composition before and after LAIV. Samples will be collected using nasosorptions and analyzed with molecular methods.
- Analysis of peripheral immune system in whole blood collected at baseline and 28 days post LAIV dose 1. Measured using tools such as spectral flow cytometry.
- Serum and mucosal IgG and IgA post-LAIV, comparing baseline to day 28 post-LAIV. Measured through binding and functional assays.
- Correlating immune responses and shedding kinetics with data from baseline questionnaire and daily questionnaires assessing RTI-related symptoms. Collected using electronic recordings.
研究者
Maurits Thomas Wulffraat
Scientific
Leids Universitair Medisch Centrum (LUMC)
研究点 (1)
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