Induction of immune tolerance vs. immunity after oral administration of an immunogenic substance

• Conditions: Healthy volunteers; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2011-001232-27-DE
• Lead Sponsor: Charité Universitaetsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-27
• Last Update Posted: 24 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• tumors
• psychiatric illness
• Drugs or drug abuse
• severe allergic reaction in the past.
• Pathological laboratory abnormalities for: serum ALT and GGT, creatinine and blood

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified