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

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ClinicalTrials.gov Identifier: NCT00389103
Recruitment Status : Withdrawn (Senior management decision)
First Posted : October 18, 2006
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE October 16, 2006
First Posted Date  ICMJE October 18, 2006
Last Update Posted Date January 22, 2014
Study Start Date  ICMJE October 2006
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2009)
Safety [ Time Frame: Study Completion ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2006)
  • Safety
  • Tolerability
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2009)
Immunogenicity [ Time Frame: Study Completion ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2006)
Immunogenicity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)
Official Title  ICMJE 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)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Smallpox
  • Atopic Dermatitis
Intervention  ICMJE Biological: MVA (smallpox vaccine)
0.5ml of MVA3000 Smallpox vaccine, administered twice separated by 28 days, subcutaneous injections
Other Name: placebo
Study Arms  ICMJE Placebo Comparator: placebo
Intervention: Biological: MVA (smallpox vaccine)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 7, 2009)
0
Original Enrollment  ICMJE
 (submitted: October 17, 2006)
45
Actual Study Completion Date  ICMJE January 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00389103
Other Study ID Numbers  ICMJE H-249-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc
PRS Account Sanofi
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP