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

This study has been terminated.
(Senior management decision)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00389103
First received: October 16, 2006
Last updated: January 14, 2009
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Smallpox
Atopic Dermatitis
 Biological: MVA (smallpox vaccine)
 Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Smallpox
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Safety [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: Study Completion ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Biological: MVA (smallpox vaccine)
0.5ml of MVA3000 Smallpox vaccine, administered twice separated by 28 days, subcutaneous injections
Other Name: placebo

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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389103

Locations
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc
  More Information

No publications provided

Responsible Party: Clinical Operations Manager, Sanofi Pasteur Inc.
ClinicalTrials.gov Identifier: NCT00389103     History of Changes
Other Study ID Numbers: H-249-005
Study First Received: October 16, 2006
Last Updated: January 14, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Smallpox
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Poxviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on June 17, 2013