A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Smallpox; Dermatitis, Atopic; Dermatitis; Eczema
Intervention: IMVAMUNE
Intervention description: Subjects receiving two subcutaneous vaccinations
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 632.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Atopic dermatitis; Smallpox; Vaccination

Summary:

      The purpose of this study is to compare the immunogenicity and safety of an investigational
      smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

        Group 1 (Healthy Participants):

        Subjects without present or history of any kind of atopy.

        Group 2 (Atopic Dermatitis Participants):

        Subjects with diagnosed atopic dermatitis.

        All study subjects:

          1. Male and female subjects between 18 and 40 years of age without history of smallpox
             vaccination.

          2. Women must have a negative serum pregnancy test at screening and a negative urine or
             serum pregnancy test within 24 hours prior to vaccination.

          3. Women of childbearing potential must have used an acceptable method of contraception
             for 30 days prior to the first vaccination, must agree to use an acceptable method of
             contraception during the study, and must not become pregnant for at least 28 days
             after the last vaccination.

          4. Lab values without clinically significant findings.

          5. Electrocardiogram (ECG) without clinically significant findings.

        Exclusion Criteria:

          1. Pregnant or breast-feeding women.

          2. Uncontrolled serious infection i.e. not responding to antimicrobial therapy.

          3. History of or active autoimmune disease. Persons with vitiligo or thyroid disease
             taking thyroid replacement are not excluded.

          4. Known or suspected impairment of immunologic function including, but not limited to,
             clinically significant liver disease; diabetes mellitus; moderate to severe kidney
             impairment.

          5. History of malignancy, other than squamous cell or basal cell skin cancer, unless
             there has been surgical excision that is considered to have achieved cure. Subjects
             with history of skin cancer at the vaccination site are excluded.

          6. History of coronary heart disease, myocardial infarction, angina, congestive heart
             failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood
             pressure.

          7. History of an immediate family member (father, mother, brother, or sister) who has had
             onset of ischemic heart disease before age 50 years.

          8. Ten percent or greater risk of developing a myocardial infarction or coronary death
             within the next 10 years using the National Cholesterol Education Program's risk
             assessment tool: (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof) NOTE:
             This criterion applies only to volunteers 20 years of age and older.

          9. History of anaphylaxis or severe allergic reaction.

         10. Post organ transplant subjects whether or not receiving chronic immunosuppressive
             therapy.

         11. Administration of immunomodulatory substances.