A Pilot Clinical Study of PET Scanning in Evaluation of Vaccine Reactogenicity

Imperial College London0 个研究点目标入组 54 人开始时间: 2016年6月10日最近更新: 2020年9月9日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Imperial College London
入组人数: 54
主要终点: 18FDG-PET/CT imaging

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study forms part of an integrated, multi-study effort to identify potential biomarkers of reactogenicity to vaccines. We have selected PET-CT as it is in routine clinical use and has been serendipitously shown to image lymph nodes and injection site inflammation after immunisation.The study's objectives are exploratory:

To methodically characterise relative anatomical distribution and intensity of post-immunisation innate immune activation visualised by PET-CT after immunisation with adjuvanted and non-adjuvanted vaccines.
To correlate PET/CT changes with diary card recorded symptoms of reactogenicity.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
主要目的: Basic Science
盲法: None

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Able to read and understand the informed consent form (ICF), and understand study procedures
•Signed the ICF
•Healthy male aged 18'Äì55 years inclusive
•BMI 19'Äì27 kg/m2
•Pre-immunised with hepatitis B vaccine on the basis of immunisation history if Fendrix or Engerix B is to be the study vaccine
•Available for follow-up for the duration of the study
•Is, in the opinion of the investigator, healthy on the basis of a medical history, symptom directed medical examination and vital signs
•Have not undergone research radiation exposures, and agree to avoid such exposures, for 12 months before/after this study
•Be willing to avoid vigorous exercise or contact sports between vaccination and PET scan (e.g. gym workouts, prolonged cycling, rowing, martial arts or rugby)

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
•Use of steroids or immunosuppressive/immunomodulating drugs either orally or parenterally within 3 months of the PET scan. (Topical/ocular/nasal/inhaled steroids are allowed.)
•Expression of only TSPO with low-affinity to PBR28, on the basis of TSPO genotype
•Currently participating in a clinical study with a drug or device
•Any condition that, in the investigator'Äôs opinion, compromises the participant'Äôs ability to meet protocol requirements or to complete the study
•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

Bexsero

Experimental

Bexsero (Meningococcal group B subunit / Outer Membrane Vesicles, GlaxoSmithKline); 0.5 mL. intramuscular. stat.

干预措施: Immunization (Biological)

Fendrix

Experimental

Fendrix (Hepatitis B surface antigen adjuvanted by AS04C containing 3¬≠O¬≠desacyl¬≠4'¬≠ monophosphoryl lipid A adsorbed on aluminium phosphate, GlaxoSmithKline; 0.5 mL. intramuscular. stat.

干预措施: Immunization (Biological)

Fluad

Experimental

Fluad (split virion inactivated seasonal trivalent influenza vaccine adjuvanted with MF59C, Northern Hemisphere 2016-17, Seqirus Vaccines and Diagnostics) 0.5 mL. intramuscular. stat.

干预措施: Immunization (Biological)

Seasonal Trivalent Influenza Vaccine

Experimental

Seasonal Trivalent Influenza Vaccine ('ÄòSTIV'Äô, split virion inactivated, Northern Hemisphere 2016-17, Sanofi Pasteur); 0.5 mL. intramuscular. stat.

干预措施: Immunization (Biological)