Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in Patients With Atopic Disorders
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
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 11, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedJanuary 10, 2019
January 1, 2019
1.7 years
September 11, 2005
January 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence, relationship and intensity of any serious adverse event at any time during the study.
Secondary Outcomes (2)
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).
Study Arms (4)
GP 1: healthy, no AD
EXPERIMENTALHealthy subjects without any history of, or current signs and symptoms of atopic disease, receiving two doses IMVAMUNE (MVA-BN), subcutaneous.
GP2: prev. allerg. rhinitis
EXPERIMENTALSubjects having documentation of at least one allergic rhinitis event during the previous year, receiving two doses IMVAMUNE (MVA-BN), subcutaneous..
GP3: history of AD
EXPERIMENTALSubjects having documentation of a history of Atopic Dermatitis, receiving two doses IMVAMUNE (MVA-BN), subcutaneous..
GP4: active AD
EXPERIMENTALSubjects presenting active Atopic Dermatitis and having an individual SCORAD value between 1 and 15, receiving two doses IMVAMUNE (MVA-BN), subcutaneous.
Interventions
1x10E08 TCID50, subcutaneous vaccination
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Infectious Diseases and Tropical Medicine
Munich, Bavaria, 80802, Germany
Related Publications (2)
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.
PMID: 25149431RESULTDarsow 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.
PMID: 27357167RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank von Sonnenburg, M.D.
Department of Infectious Diseases and Tropical Medicine of the University of Munich
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2005
First Posted
September 19, 2005
Study Start
April 1, 2004
Primary Completion
December 1, 2005
Last Updated
January 10, 2019
Record last verified: 2019-01