Status:
COMPLETED
A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
Lead Sponsor:
Bavarian Nordic
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief 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
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
632 Patients enrolled
Trial Details
Trial ID
NCT00316602
Start Date
July 1 2006
End Date
April 1 2010
Last Update
January 9 2019
Active Locations (22)
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1
Alta Clinical Research LLC
Tucson, Arizona, United States, 85745
2
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
3
Rx Clinical Research, Inc.
Garden Grove, California, United States, 92843
4
Solano Clinical Research
Vallejo, California, United States, 94589