Clinical Study to Generate a Set of Data Characterising Clinical Events, Physiological Responses, and Innate and Adaptive Immune Responses Following a Single IM Immunisation With Fluad Seasonal Influenza Vaccine or Placebo in Healthy Adults

University Hospital, Ghent2 个研究点分布在 1 个国家目标入组 240 人开始时间: 2014年10月2日最近更新: 2022年12月20日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: University Hospital, Ghent
入组人数: 240
试验地点: 2
主要终点: Frequency of local and systemic vaccine-related clinical events.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this protocol is to generate a set of data that will be analysed by integrated systems biology approach, for validation in subsequent clinical trials or in animal models.

240 healthy participants (18-45y) will be enrolled, 228 will be administered a dose of Fluad on Day 0, 12 will receive a placebo on Day 0.

详细描述

This study is part of the BIOVACSAFE project, a 5-year project funded by the Innovative Medicine Initiative, which will undertake a series of correlated clinical studies that will apply and develop technologies to generate clinical data on inflammation with licensed vaccines as benchmarks, and identify biomarkers to predict acceptable reactogenicity, for correlation with standardized clinical readouts and inflammatory markers assessed in natural infections.

The purpose of this protocol is to generate a set of data that will be analysed by integrated systems biology approach, for validation in subsequent clinical trials or in animal models. The dataset will broadly characterise:

Physiological responses at various time points after immunisation by measuring:
Local and systemic vaccine-related clinical events.
Physiological assessments: heart rate, temperature, blood pressure.
Haematology (blood counts and ESR), biochemistry parameters.
Metabolic, innate and adaptive immune responses including:
Innate immune activation detected by global gene expression in whole blood
Metabolic responses detected by metabolic gene expression and pathway activation in whole blood
Adaptive immunity determined by:

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy male or female subjects aged 18-45 years inclusive.
•Male: Female ratio - Screening will ensure that no more than 2/3 of the population should be of either male or female
•The subject is, in the opinion of the investigator: healthy based on medical history and clinical exam, with no active disease process that could interfere with the study endpoints.
•Has a body Mass Index ≥18 and ≤30
•Is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
•The subject has signed the ICF.
•The subject is available for follow-up for the duration of the study.
•The subject agrees to abstain from donating blood during their participation in the study, or longer if necessary.
•If the subject is a heterosexually active female, she is willing to use an effective method of contraception with partner (oral contraceptive pill; intrauterine device; injectable or implanted contraceptive; condoms incorporating spermicide if using these; physiological or anatomical sterility) from 30 days prior to, and 3 months after, vaccination. Willing to undergo urine pregnancy tests prior to vaccination at screening.
•The subject has venous access sufficient to allow blood sampling as per the protocol.

排除标准

•Pregnant or lactating at any point during the study from screening to final follow up.
•Hypersensitivity to the active components of FLUAD, any of the excipients, eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde, and cetyltrimetholammonium bromide or those who have had a previous life-threatening reaction to previous influenza vaccinations.
•Presence of primary or acquired immunodeficiency states with a total lymphocyte count less than 1,200 per mm3 or presenting other evidence of lack of cellular immune competence e.g. leukaemias, lymphomas, blood dyscrasias, or patients receiving immunosuppressive therapy (including regular use of oral or parenteral corticosteroids).
•Use of any immune suppressing or immunomodulating drugs within 6 months of Visit
•Regular use of non-steroidal anti-inflammatory drugs (oral or parenteral route) within 6 months of Visit 1 considered by the study physician as likely to interfere with immune responses.
•Current intake of excessive amounts of alcohol and/or caffeine (as evaluated by the investigator) and not willing to adapt this use during the study period.
•Currently performing extreme physical activities (as evaluated by the investigator) and not willing to adapt this use during the study period.
•Receipt of a vaccine within 30 days of visit 1, or requirement to receive another vaccine within the study period.
•Vaccination with the 2014/2015 seasonal influenza vaccine and/or any other seasonal influenza vaccine within the last 6 months before the first study visit.
•Presence of an acute severe febrile illness at time of immunisation.
•History of alcohol, narcotic, benzodiazepine, rilatine, or other substance abuse or dependence within the 12 months preceding Visit
•Currently participating in another clinical study with an investigational or non-investigational drug or device, or has participated in a clinical trial within the 3 months preceding Visit
•Any condition that, in the investigator's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.
•Receipt of blood products or immunoglobin, or blood donation, within 3 months of screening.
•Unable to read and speak Dutch or English to a fluency level adequate for the full comprehension of procedures required in participation and consent.

结局指标

主要结局

Frequency of local and systemic vaccine-related clinical events.

时间窗: At all time points from vaccination up to 28 days after vaccination

Change from pre-immunisation baseline values in global gene expression measured on whole blood samples.