Clinical trial NCT00389103: Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)
Official title: A Phase 1, Placebo-Controlled, Double-Blind Study of the Safety and Immunogenicity of Two Injections of MVA3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Vaccinia Naive Adult Subjects With a History of Atopic Dermatitis (AD)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Smallpox
Atopic Dermatitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Safety
timeFrame: Study Completion
Secondary outcomes:
measure: Immunogenicity
timeFrame: Study Completion
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
Study officials:
affiliation: Sanofi Pasteur Inc
name: Medical Director
role: STUDY_DIRECTOR
References: