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

Sanofi

Status and phase

Withdrawn

Phase 1

Conditions

Atopic Dermatitis

Smallpox

Treatments

Biological: MVA (smallpox vaccine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00389103

H-249-005

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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