Clinical trial NCT00189917: Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in Patients With Atopic Disorders
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dermatitis, Atopic
Hay Fever
Lead sponsor: Bavarian Nordic
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2005-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Primary outcomes:
measure: Occurrence, relationship and intensity of any serious adverse event at any time during the study.
Secondary outcomes:
measure: ELISA specific seroconversion rates and geometric mean titres (at all blood sampling time points).
measure: Neutralisation assay specific seroconversion rates and geometric mean titres (at all blood sampling time points).
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Infectious Diseases and Tropical Medicine
state: Bavaria
Study officials:
affiliation: Department of Infectious Diseases and Tropical Medicine of the University of Munich
name: Frank von Sonnenburg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: von Sonnenburg F, Perona P, Darsow U, Ring J, von Krempelhuber A, Vollmar J, Roesch S, Baedeker N, Kollaritsch H, Chaplin P. Safety and immunogenicity of modified vaccinia Ankara as a smallpox vaccine in people with atopic dermatitis. Vaccine. 2014 Sep 29;32(43):5696-702. doi: 10.1016/j.vaccine.2014.08.022. Epub 2014 Aug 20.
citation: Darsow U, Sbornik M, Rombold S, Katzer K, von Sonnenburg F, Behrendt H, Ring J. Long-term safety of replication-defective smallpox vaccine (MVA-BN) in atopic eczema and allergic rhinitis. J Eur Acad Dermatol Venereol. 2016 Nov;30(11):1971-1977. doi: 10.1111/jdv.13797. Epub 2016 Jun 29.