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

Primary Purpose

Dermatitis, Atopic, Hay Fever

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
IMVAMUNE (MVA-BN)
Sponsored by
Bavarian Nordic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dermatitis, Atopic

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Infectious Diseases and Tropical Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

GP 1: healthy, no AD

GP2: prev. allerg. rhinitis

GP3: history of AD

GP4: active AD

Arm Description

Healthy subjects without any history of, or current signs and symptoms of atopic disease, receiving two doses IMVAMUNE (MVA-BN), subcutaneous.

Subjects having documentation of at least one allergic rhinitis event during the previous year, receiving two doses IMVAMUNE (MVA-BN), subcutaneous..

Subjects having documentation of a history of Atopic Dermatitis, receiving two doses IMVAMUNE (MVA-BN), subcutaneous..

Subjects presenting active Atopic Dermatitis and having an individual SCORAD value between 1 and 15, receiving two doses IMVAMUNE (MVA-BN), subcutaneous.

Outcomes

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).

Full Information

First Posted
September 11, 2005
Last Updated
January 8, 2019
Sponsor
Bavarian Nordic
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00189917
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2004 (Actual)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
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3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bavarian Nordic
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic, Hay Fever

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GP 1: healthy, no AD
Arm Type
Experimental
Arm Description
Healthy subjects without any history of, or current signs and symptoms of atopic disease, receiving two doses IMVAMUNE (MVA-BN), subcutaneous.
Arm Title
GP2: prev. allerg. rhinitis
Arm Type
Experimental
Arm Description
Subjects having documentation of at least one allergic rhinitis event during the previous year, receiving two doses IMVAMUNE (MVA-BN), subcutaneous..
Arm Title
GP3: history of AD
Arm Type
Experimental
Arm Description
Subjects having documentation of a history of Atopic Dermatitis, receiving two doses IMVAMUNE (MVA-BN), subcutaneous..
Arm Title
GP4: active AD
Arm Type
Experimental
Arm Description
Subjects presenting active Atopic Dermatitis and having an individual SCORAD value between 1 and 15, receiving two doses IMVAMUNE (MVA-BN), subcutaneous.
Intervention Type
Biological
Intervention Name(s)
IMVAMUNE (MVA-BN)
Intervention Description
1x10E08 TCID50, subcutaneous vaccination
Primary Outcome Measure Information:
Title
Occurrence, relationship and intensity of any serious adverse event at any time during the study.
Secondary Outcome Measure Information:
Title
ELISA specific seroconversion rates and geometric mean titres (at all blood sampling time points).
Title
Neutralisation assay specific seroconversion rates and geometric mean titres (at all blood sampling time points).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank von Sonnenburg, M.D.
Organizational Affiliation
Department of Infectious Diseases and Tropical Medicine of the University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Infectious Diseases and Tropical Medicine
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80802
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25149431
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.
Results Reference
result
PubMed Identifier
27357167
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.
Results Reference
result

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

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