Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in Patients With Atopic Disorders

Inclusion criteria

All subjects

• Age 18-40.
• Read, signed and dated informed consent.
• Women of childbearing potential must use an acceptable method of contraception

Group 1: Healthy subjects

• No history of atopic dermatitis as documented in the patient file
• No active atopic dermatitis
• No other atopic disorders such as asthma or allergic rhinitis.
• Prick test without clinical significance
• IgE within normal range

Group 2: Subjects with history of atopic dermatitis

Group 3: Subjects with mild active atopic dermatitis

• SCORAD 1 - 15.

Group 4: Subjects with mild allergic rhinitis

• At least one active allergic rhinitis phase during last year.

Exclusion criteria

• Known or suspected history of smallpox vaccination or typical vaccinia scar.
• Positive test result in MVA specific ELISA at screening.
• Positive result in HIV or HCV antibody test at screening.
• Surface antigen of Hepatitis B Virus (HBsAg) positive at screening.
• Pregnant or breast-feeding women.
• Positive pregnancy test at screening and/or within 24 hours prior to vaccination.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the institutional upper limit of normal.
• Positive urine glucose by dipstick or urine analysis.
• Inadequate renal function defined as a serum creatinine above the institutional upper limit of normal; urine protein >30 mg/dl or trace proteinuria (by urine analysis or dipstick); and a calculated creatinine clearance <80 ml/min.
• Electrocardiogram (ECG) with clinical significance.
• Hemoglobin <11 g/dl; White blood cells less than 2,500 and more than 11,000/mm3; Platelets less than 140,000/mm3.
• Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
• History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject.
• History of or active autoimmune disease.
• Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
• History of malignancy.
• History or clinical manifestation of clinically significant mental illness or haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
• Any condition which might interfere with study objectives.
• History of immunodeficiency.
• History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or other heart condition under the care of a doctor.
• Three or more of the following risk factors: High blood pressure, high blood cholesterol, diabetes mellitus or high blood sugar, a first degree relative who had a heart condition before the age of 50, smoking cigarettes.
• History of chronic alcohol abuse and/or intravenous drug abuse.
• History of allergic reactions likely to be exacerbated by any component of the vaccine.
• History of anaphylaxis or severe allergic reaction.
• Acute disease (illness with or without a fever) at the time of enrollment.
• Any vaccinations within a period starting 30 days prior to administration of the vaccine and ending at study conclusion.
• Chronic administration of immuno-suppressant or immune-modifying drugs.
• Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
• Administration or planned administration of immunoglobulins and/or any blood -- Use of any investigational or non-registered drug.
• Blood donation 8 weeks in advance or during study participation.