Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)

Study Overview
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Brief Summary
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purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with a history of mild to moderate Atopic Dermatitis.

Detailed Description
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This is a randomized, double-blind, placebo-controlled study. subjects will be randomized to receive investigational vaccine or placebo at a ratio of 3.5:1, MVA3000 to placebo. All subjects will undergo a screening period, a treatment/observation period during which all subjects will receive injections on study day 0 and study day 28 of investigational vaccine or placebo. The clinical observation period will be completed at day 56. A visit will occur at approximately 3 months after the second study injection (study day 118) for additional blood collection and a review of the subject's health status. Follow-up will be obtained via telephone contacts approximately 6 months after the end of the second injection during the treatment/observation period.

Official Title
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A Phase 1, Placebo-Controlled, Double-Blind Study of the Safety and Immunogenicity of Two Injections of MVA3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Vaccinia Naive Adult Subjects With a History of Atopic Dermatitis (AD)

Conditions
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Smallpox, Atopic Dermatitis

Intervention / Treatment
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* Biological: MVA (smallpox vaccine)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults at least 18 years old and who were born after 1971 with no previous history of smallpox vaccination Subjects must be in good general health Female subjects must not be pregnant or lactating and must agree to practice birth control during the course of the study Subjects must have a diagnosis of AD by an experienced clinician that includes a history of both major and minor diagnostic criteria At the time of screening, the subject must have mild to moderate AD. Exclusion Criteria: History or evidence of prior exposure to a vaccinia or MVA- containing product known or suspected history of immunodeficiency other than AD Known or suspected impairment of major organ function Known history or diagnosis of cardiac disease or cerebrovascular disease presence of acute, chronic, or active exfoliative skin conditions other than AD, open wounds, or burns. Dementia or history of seizures Known allergies to MVA or any known components of the vaccine transfusion of blood, organ transplantation, or treatment with any blood product morbid obesity, or a BMI less than or equal to 18.5 history of or current drug or alcohol abuse (except nicotine) within the past 6 months or any history of IV drug use history of major psychiatric illness except major depression not requiring medical therapy. subjects who have participated in another investigational drug or vaccine trial within 30 days of study day 0

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Biological: MVA (smallpox vaccine)<br>* 0.5ml of MVA3000 Smallpox vaccine, administered twice separated by 28 days, subcutaneous injections<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | Study Completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity |  | Study Completion |