Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (Senior management decision)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 )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Smallpox Atopic Dermatitis Biological: MVA (smallpox vaccine) Phase 1

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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)
Study Start Date : October 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Smallpox

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: placebo Biological: MVA (smallpox vaccine)
0.5ml of MVA3000 Smallpox vaccine, administered twice separated by 28 days, subcutaneous injections
Other Name: placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Safety [ Time Frame: Study Completion ]

Secondary Outcome Measures :
  1. Immunogenicity [ Time Frame: Study Completion ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389103


Locations
Layout table for location information
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 Pasteur, a Sanofi Company
Investigators
Layout table for investigator information
Study Director: Medical Director Sanofi Pasteur Inc
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00389103    
Other Study ID Numbers: H-249-005
First Posted: October 18, 2006    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Smallpox
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
 Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Poxviridae Infections
DNA Virus Infections
Virus Diseases