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

NCT00389103 | Withdrawn Phase 1 DMC

• 1 other identifier: H-249-005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Smallpox; Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Safety

  Study Completion

Secondary Outcomes (1)

• Immunogenicity

  Study Completion

Study Arms (1)

placebo

PLACEBO COMPARATOR

Biological: MVA (smallpox vaccine)

Interventions

MVA (smallpox vaccine) BIOLOGICAL

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

Also known as: placebo

placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (3)

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Smallpox; Dermatitis, Atopic

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Medical Director

  Sanofi Pasteur Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2006
• First Posted: October 18, 2006
• Study Start: October 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

US (3)