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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Smallpox Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

MVA (smallpox vaccine)

Intervention Type BIOLOGICAL

0.5ml of MVA3000 Smallpox vaccine, administered twice separated by 28 days, subcutaneous injections

Interventions

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MVA (smallpox vaccine)

0.5ml of MVA3000 Smallpox vaccine, administered twice separated by 28 days, subcutaneous injections

Intervention Type BIOLOGICAL

Other Intervention Names

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placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes