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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00189917
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : June 3, 2015
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
Bavarian Nordic

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Hay Fever Biological: IMVAMUNE (MVA-BN) Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-label, Controlled Phase I Pilot Study to Evaluate Safety and Immunogenicity of MVA-BN® Smallpox Vaccine in 18-40 Year Old Vaccinia-naïve Subjects With Atopic Disorders
Study Start Date : April 2004
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smallpox
U.S. FDA Resources

Primary Outcome Measures :
  1. Occurrence, relationship and intensity of any serious adverse event at any time during the study.

Secondary Outcome Measures :
  1. ELISA specific seroconversion rates and geometric mean titres (at all blood sampling time points).
  2. Neutralisation assay specific seroconversion rates and geometric mean titres (at all blood sampling time points).

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00189917

Department of Infectious Diseases and Tropical Medicine
Munich, Bavaria, Germany, 80802
Sponsors and Collaborators
Bavarian Nordic
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Frank von Sonnenburg, M.D. Department of Infectious Diseases and Tropical Medicine of the University of Munich

Publications of Results: Identifier: NCT00189917     History of Changes
Other Study ID Numbers: POX-MVA-007
NIH N01-AI-30016
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Dermatitis, Atopic
Rhinitis, Allergic, Seasonal
Skin Diseases
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases