Homing potential of the antigen specific B cell and antibody mediated immune response after vaccination

Helsinki University Central Hospital0 个研究点开始时间: 2012年3月28日最近更新: 2012年4月18日

试验速览

暂无简介。

•1. Male or female subjects aged =18 to =65 years
•2. General good health as established by medical history and physical examination
•3. Written informed consent
•4. Available for all visits scheduled in this study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 380
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Vaccination against same pathogen in resently
•2. Resent history of disease that is causing by pathogen which against the vaccine is indicated.
•3. Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within
•4. Current intake of antibiotics or end of antibiotic therapy <8 days before first IMP administration of oral vaiinse
•5. 6 months before the first dose of IMP; oral corticosteroids in dosages of =0.5 mg/kg/d prednisolone or equivalent
•are excluded; inhaled or topical steroids are allowed
•6. Acute or chronic clinically significant gastrointestinal disease
•7. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human
•immunodeficiency virus (HIV) infection
•8. Pregnancy or lactation
•9. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without
•fever (fever is defined as body temperature of =38 °C).
•10. Alcohol or drug abuse
•11. Suspected non-compliance
•12. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator

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