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| ID | Type | Description | Link |
|---|---|---|---|
| N01-AI-30016 | Other Grant/Funding Number | NIAID |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in populations with atopic disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GP 1: healthy, no AD | Experimental | Healthy subjects without any history of, or current signs and symptoms of atopic disease, receiving two doses IMVAMUNE (MVA-BN), subcutaneous. |
|
| GP2: prev. allerg. rhinitis | Experimental | Subjects having documentation of at least one allergic rhinitis event during the previous year, receiving two doses IMVAMUNE (MVA-BN), subcutaneous.. |
|
| GP3: history of AD | Experimental | Subjects having documentation of a history of Atopic Dermatitis, receiving two doses IMVAMUNE (MVA-BN), subcutaneous.. |
|
| GP4: active AD | Experimental | Subjects presenting active Atopic Dermatitis and having an individual SCORAD value between 1 and 15, receiving two doses IMVAMUNE (MVA-BN), subcutaneous. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMVAMUNE (MVA-BN) | Biological | 1x10E08 TCID50, subcutaneous vaccination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence, relationship and intensity of any serious adverse event at any time during the study. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
All subjects
Group 1: Healthy subjects
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank von Sonnenburg, M.D. | Department of Infectious Diseases and Tropical Medicine of the University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Infectious Diseases and Tropical Medicine | Munich | Bavaria | 80802 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25149431 | Result | 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. | |
| 27357167 |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C527606 | smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic |
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| 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. |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |