Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-24 @ 7:14 PM
NCT ID:
NCT00389103
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT00389103
Study Brief:
Protocol Section:
NCT00389103