NCT02368327已完成不适用
Clinical Study to Generate Exploratory Training Set of Data on the Time Course of Gene Expression Profile at Site of Antigen Deposition Compared With Whole Blood Following IM Injection With Alum or MF59-adjuvanted Protein Subunit Vaccines
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change from baseline values of gene expression in whole blood and muscle
研究概览
简要总结
This clinical study is part of the BIOVACSAFE project which is funded by the Innovative Medicine Initiative. In this study we will take a small muscle biopsy in order to identify any differences in the response around the actual site of injection compared with responses we measure in blood at the same time.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •The participant is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
- •The participant has signed the ICF.
- •Healthy male participants aged 18-45 years inclusive.
- •BMI between 19-27 kg/m
- •Pre-immunised with Hepatitis B vaccine
- •Hepatitis B sAb positive (evidence of vaccine-induced immunity)
- •Hepatitis B sAg and cAb negative (evidence of lack of prior/current HBV infection)
- •Hepatitis C and HIV seronegative.
- •Available for follow-up for the duration of the study.
- •Agree to abstain from donating blood during the study.
- •The participant is, in the opinion of the investigator, healthy on the basis of a, medical history, a symptom directed medical examination and vital signs.
排除标准
- •History of hypersensitivity to any of the vaccine components or a history of any allergy that in the opinion of the investigator would contraindicate participant participation
- •Clinically significant psychiatric, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological (particularly myasthenia gravis), immunological, or haematological disease or abnormality, as determined by the study physician.
- •Known immune or coagulation disorder or clinically significant abnormalities of platelets, Hb or coagulation on screening labs
- •Known allergy to injected local anaesthetics
- •Unwilling to undergo muscle biopsies
- •Use of steroids or immunosuppressive/immunomodulating drugs either orally or parenterally within 3 months of visit
- •Currently participating in a clinical trial with an investigational or non- investigational drug or device, or has participated in another clinical trial within the 3 months preceding the study.
- •Any condition that, in the investigator's opinion, compromises the participant's ability to meet protocol requirements or to complete the study.
- •Receipt of blood products or immunoglobin, within 3 months of visit
- •Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants receive one dose of saline placebo
干预措施: Placebo (Biological)
Fendrix
Active Comparator
Participants receive one dose of Fendrix vaccine
干预措施: Fendrix (Biological)
Fluad
Active Comparator
Participants receive one dose of Fluad vaccine
干预措施: Fluad (Biological)
结局指标
主要结局
Change from baseline values of gene expression in whole blood and muscle
时间窗: Day 0, Day 0+3 hours, Day 1, Day 3, Day 5 and Day 7
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Chronic Obstructive Pulmonary Disease (COPD) Breathing Record StudyPulmonary Disease, Chronic ObstructiveNCT02814253TidalSense30
终止
不适用
An In-vitro Standardization of B Cell Elispot AssaysTransplant SensitizationPanel Reactive AntibodySensitization to HLA AntigensNCT01334281Northwestern University19
招募中
2 期
A Clinical Study to Visualize Microvessels Using Photoacoustic Imaginglymphedema of the extremitiesLymphedemaD008209JPRN-jRCTs032210561Kishi Kazuo120
招募中
1 期
A Clinical Study to Visualize Vessels Using PhotoacousticImagingVarix, peripheral vascular disease, diabetes mellitus, vasculitis, Raynaud s syndrome, hemangioma, vVascular diseaseI839, E14, L959, I730, D180, Q279JPRN-jRCTs032210555Obara Hideaki30
招募中
1 期
An Exploratory Clinical Study to Evaluate the Safety, Tolerability, Immune Response and Preliminary Efficacy of LM103 Injection in Combination With PD-1 in Patients With Advanced Solid TumoursSolid CancerNCT06697665Suzhou BlueHorse Therapeutics Co., Ltd.10