Status:
COMPLETED
Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in Patients With Atopic Disorders
Lead Sponsor:
Bavarian Nordic
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Dermatitis, Atopic
Hay Fever
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in populations with atopic disorders.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00189917
Start Date
April 1 2004
Last Update
January 10 2019
Active Locations (1)
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1
Department of Infectious Diseases and Tropical Medicine
Munich, Bavaria, Germany, 80802