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

Phase 1

Withdrawn

• Conditions: Smallpox; Atopic Dermatitis
• Interventions: Biological: MVA (smallpox vaccine)

• Registration Number: NCT00389103
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-16
• Study First Submitted QC: 2006-10-17
• Study First Posted: 2006-10-18
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-17
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	MVA (smallpox vaccine)	-

Primary Outcome Measures

Name	Time	Method
Safety	Study Completion

Secondary Outcome Measures

Name	Time	Method
Immunogenicity	Study Completion

Trial Locations

Locations (3)

Academic Dermatology Associates; 🇺🇸 Albuquerque, New Mexico, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

DermResearch, Inc.; 🇺🇸 Austin, Texas, United States