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

Atopic Dermatitis Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00389103
• Other study ID #: H-249-005
• Status: Withdrawn
• Phase: Phase 1
• First received: October 16, 2006
• Last updated: January 17, 2014
• Start date: October 2006
• Est. completion date: January 2007

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Smallpox

Intervention

Biological:
• MVA (smallpox vaccine)
0.5ml of MVA3000 Smallpox vaccine, administered twice separated by 28 days, subcutaneous injections

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	DermResearch, Inc.	Austin	Texas
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		Study Completion	Yes
Secondary	Immunogenicity		Study Completion	No

External Links

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