Atopic Dermatitis, Smallpox
Conditions
Brief summary
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.
Detailed description
This is a randomized, double-blind, placebo-controlled study. subjects will be randomized to receive investigational vaccine or placebo at a ratio of 3.5:1, MVA3000 to placebo. All subjects will undergo a screening period, a treatment/observation period during which all subjects will receive injections on study day 0 and study day 28 of investigational vaccine or placebo. The clinical observation period will be completed at day 56. A visit will occur at approximately 3 months after the second study injection (study day 118) for additional blood collection and a review of the subject's health status. Follow-up will be obtained via telephone contacts approximately 6 months after the end of the second injection during the treatment/observation period.
Interventions
BIOLOGICALMVA (smallpox vaccine)
0.5ml of MVA3000 Smallpox vaccine, administered twice separated by 28 days, subcutaneous injections
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | Study Completion |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity | Study Completion |
Countries
United States
Outcome results
None listed