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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Bavarian Nordic
ClinicalTrials.gov Identifier:
NCT00189917
First received: September 11, 2005
Last updated: October 10, 2006
Last verified: October 2006
  Purpose

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 Intervention Phase
Dermatitis, Atopic
Hay Fever
Biological: IMVAMUNE (MVA-BN)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bavarian Nordic:

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

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

Estimated Enrollment: 60
Study Start Date: April 2004
Estimated Study Completion Date: April 2006
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189917

Locations
Germany
Department of Infectious Diseases and Tropical Medicine
Munich, Bavaria, Germany, 80802
Sponsors and Collaborators
Bavarian Nordic
Investigators
Principal Investigator: Frank von Sonnenburg, M.D. Department of Infectious Diseases and Tropical Medicine of the University of Munich
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00189917     History of Changes
Other Study ID Numbers: POX-MVA-007, NIH N01-AI-30016
Study First Received: September 11, 2005
Last Updated: October 10, 2006
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on September 14, 2014