Characterization of human peripheral and intestinal T-cell responses after mucosal antigen exposure: induction of tolerance vs. immunization by oral administration of KLH

Charité Universitaetsmedizin Berlin0 个研究点开始时间: 2011年12月27日最近更新: 2015年8月24日

试验速览

暂无简介。

•Written consent (according to § 40 AMG (1) 3 b)
•Age 18 - 69 years
•• negative pregnancy test
•• highly effective contraception in women (defined as the Pearl Index <1)
•No participation in another study by the AMG one month before and during participation, and after 5 half-lives of / investigational product / s from the previous AMG study
•During the study, taking a normal diet
•For the group A5 is also the inclusion criterion
•Indication for elective resection for diverticulitis
•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 64
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Pregnancy and lactation
•contraindications to study medication (including excipients of the pharmaceutical form)
•immunodeficiency
•Hypersensitivity to exogenous protein
•Interactions with the study medication (KLH)
•Use of gastric acid-inhibiting agents (H2 blockers, proton pump inhibitors (PPIs)
•Immunosuppressive or anti-inflammatory medication
•vaccination three months before or during participation
•lack of willingness to store and transfer data pseudonymous disease in the clinical examination
•Accommodation in an institution of judicial or administrative order
•chronic infections (eg chronic hepatitis, tuberculosis)
•Chronic diseases (eg severe asthma, chronic obstructive pulmonary disease, autoimmune diseases)
•serious illness of important organs (liver, kidney, GFR calculated <60 ml / min, lung, heart. Clinical signs of heart failure> NYHA I, left ventricular ejection fraction <45%, absolute arrhythmia with atrial fibrillation with the need for medical anticoagulation, non-drug controlled heart rhythm disorder), hemodynamically relevant pericardial effusion-)
•fatal cerebrovascular events currently or in the case history (eg, TIA, PRIND) and other CNS disorders such as multiple sclerosis, myasthenia gravis
•Diabetes mellitus
•psychiatric illness
•Drugs or drug abuse
•severe allergic reaction in the past.
•Pathological laboratory abnormalities for: serum ALT and GGT, creatinine and blood

发起方

Charité Universitaetsmedizin Berlin