A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
Atopic Dermatitis
About this trial
This is an interventional prevention trial for Atopic Dermatitis focused on measuring Atopic dermatitis, Smallpox, Vaccination
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: Male and female subjects between 18 and 40 years of age without history of smallpox vaccination. Women must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours prior to vaccination. 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. Lab values without clinically significant findings. Electrocardiogram (ECG) without clinically significant findings. Exclusion Criteria: Pregnant or breast-feeding women. Uncontrolled serious infection i.e. not responding to antimicrobial therapy. History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. 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, 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. History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure. History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before age 50 years. 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. History of anaphylaxis or severe allergic reaction. Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy. Administration of immunomodulatory substances.
Sites / Locations
- Alta Clinical Research LLC
- Burke Pharmaceutical Research
- Rx Clinical Research, Inc.
- Solano Clinical Research
- Northwestern University
- Adult & Pediatric Dermatology PC
- University of Kentucky Medical Center
- Saint Louis University
- Sundance Clinical Research
- Meridian Clinical Research
- Academic Dermatology Associates
- Dermatology Associates of Rochester
- Oregon Dermatology & Research Center
- Dermatology Treatment & Research Center
- Dermatology Clinical Research
- Hospital Juárez de México
- Instituto Dermatologico de Jalisco "Dr. Jose Barba Rubio"
- Hospital General de México
- CIFBIOTEC (Centro de Investigacion Farmacologica y Biotecnologica)
- Hospital Regional Lic. Adolfo Lopez Mateos. ISSSTE Ciudad de Mexico
- Centro Regional de Alergia e Inmunología Clínica del Hospital Universitario "Dr. José Eleuterio González"
- Hospital Angel Leañol, Dermatology
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Healthy Participants
Atopic Dermatitis Participants
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
Vaccinia naive subjects with diagnosed Atopic Dermatitis. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD [SCORAD] <= 30), receiving two doses of MVA-BN (IMVAMUNE)