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临床试验/NCT03875703
NCT03875703招募中不适用

Biological Collection for Studying Vaccine-induced Immune Responses

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,200
试验地点
1
主要终点
Change in transcriptional analysis, analysis of the innate immune response after vaccination

研究概览

简要总结

Introduction: Vaccination is a powerful weapon in the fight against infectious diseases, which has led to dramatic reduction in mortality and complications from some diseases. In this respect, vaccination is a real worldwide public health challenge (WHO). Thus, vaccine research benefits from an exponential development of knowledge in immunology and biotechnology. In particular, the advent of recent tools ("omics", new cytometric assays) and the description of new categories of immune cells (Tfh, BReg...) have revolutionized the characterization of immune responses, particularly post-vaccination. To study of the immune response following vaccination remains essential in order to define the immunological correlates to vaccine protection. This response also varies according to parameters related to the vaccine (type, adjuvant, dose, regimen...) and to the vaccinated host (genetics, age, morbidity, treatment ...). Analyzing with new generation immune assays, new data on immunological responses post-vaccination from a clinical cohort is therefore essential to better define these correlates.

Objective: To develop new vaccines (HIV, emerging infectious diseases) the investigators use a "System vaccinology" method to decipher the mechanisms of immune responses set up against vaccines currently being developed or marketed, specifically in specific populations (patients with primary immune deficiency, sickle cell patients, solid organ transplanted patients, COPD).

Method: Description of the genetic, molecular and cellular mechanisms of the immune response to vaccines recommended for adults, in particular influenza and pneumococcal vaccines, but also other mandatory vaccines (MMR,...) or vaccine for travelers (yellow fever, ...) as part of routine care in different population categories (healthy subjects, HIV+ subjects, COPD patients, ...), using qualitative and quantitative immunological assays: transcriptional analysis of the dynamic innate immune response, analysis of the lymphocytes B & T responses (phenotype, repertoire analysis, functional analysis including T reg and TFH populations, antibody response), genetic analysis in the context of primary immune deficiencies) Conclusion: The data generated will allow the best possible analysis of vaccine responses according to vaccines and vaccinated populations, providing important information for the research developed within the department.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years old
  • Informed and consented
  • Need to be vaccinated for routine care

排除标准

  • Person under guardianship or safeguards
  • Pregnant or breastfeeding woman
  • No affiliation to a health insurance scheme

结局指标

主要结局

Change in transcriptional analysis, analysis of the innate immune response after vaccination

时间窗: Hour 24 after vaccination

Transcriptomic analysis performed from whole blood samples

次要结局

  • T cell immune response(at Day 0, Day 7, Day 14 and Month 1 after vaccination)
  • B cell immune response(at Day 0, Day 7, Day 14 and Month 1 after vaccination)
  • Specific antibody response to the used vaccines at M1(at Month 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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