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

Withdrawn before enrolling · Phase 1 · Has a placebo group

Conditions studied: Smallpox, Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT00389103

Run by

Sanofi Pasteur, a Sanofi Company

People needed

0

Starts

2006-10-01

Expected to finish

2007-01-01

Last updated by the study team

2014-01-22

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• Oregon Health & Science University — Portland, Oregon, United States
• DermResearch, Inc. — Austin, Texas, United States

Full record on ClinicalTrials.gov

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