Healthy volunteers
Conditions
Interventions
Product Name: Keyhole limpet hemocyanin
Pharmaceutical Form:
CAS Number: 9013-72-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.1-
Product Name
Sponsors
Charité Universitaetsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety of immunization with KLH following oral and / or parenteral administration;Secondary Objective: Occurrence of a cutaneous immune response of type IV (delayed type, delayed type hypersensitivity "DTH") after immunization Detectable KLH-specific T- and B-cell responses;Primary end point(s): Frequency of adverse events after oral and/or parenteral KLH administration;Timepoint(s) of evaluation of this end point: Adverse events will be assessed at the study visits | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Occurence of a cutaneous DTH reaction KLH-specific T- and B-cell responses;Timepoint(s) of evaluation of this end point: DTH reactions will be assessed 24h and 48h after parenteral immunization KLH-specific T- and B-cell responses will be examined at the study visits | — |
Countries
Germany
Outcome results
None listed