A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis

Completed · Phase 2

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT00316602

Run by

Bavarian Nordic

People needed

632

Starts

2006-07-01

Expected to finish

2010-04-01

Last updated by the study team

2019-01-09

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Alta Clinical Research LLC — Tucson, Arizona, United States
• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Rx Clinical Research, Inc. — Garden Grove, California, United States
• Solano Clinical Research — Vallejo, California, United States
• Northwestern University — Chicago, Illinois, United States
• Adult & Pediatric Dermatology PC — Overland Park, Kansas, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• Saint Louis University — St Louis, Missouri, United States
• Sundance Clinical Research — St Louis, Missouri, United States
• Meridian Clinical Research — Omaha, Nebraska, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• Dermatology Associates of Rochester — Rochester, New York, United States
• Oregon Dermatology & Research Center — Portland, Oregon, United States
• Dermatology Treatment & Research Center — Dallas, Texas, United States
• Dermatology Clinical Research — San Antonio, Texas, United States
• Hospital Juárez de México — Magdalena de las Salinas, CP, Mexico
• Instituto Dermatologico de Jalisco "Dr. Jose Barba Rubio" — Guadalajara, Jalisco, Mexico
• Hospital General de México — Mexico City, Mexico
• CIFBIOTEC (Centro de Investigacion Farmacologica y Biotecnologica) — Mexico City, Mexico
• Hospital Regional Lic. Adolfo Lopez Mateos. ISSSTE Ciudad de Mexico — Mexico City, Mexico
• Centro Regional de Alergia e Inmunología Clínica del Hospital Universitario "Dr. José Eleuterio González" — Monterrey, Mexico
• Hospital Angel Leañol, Dermatology — Zapopan, Jalisco, Mexico

Full record on ClinicalTrials.gov

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