Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)
This study has been withdrawn prior to enrollment.
(Senior management decision)
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
First received: October 16, 2006
Last updated: January 17, 2014
Last verified: January 2014
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.
Biological: MVA (smallpox vaccine)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
||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)
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2007 (Final data collection date for primary outcome measure)
Placebo Comparator: placebo
Biological: MVA (smallpox vaccine)
0.5ml of MVA3000 Smallpox vaccine, administered twice separated by 28 days, subcutaneous injections
Other Name: placebo
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.
|Ages Eligible for Study:
||18 Years to 35 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389103
|Academic Dermatology Associates
|Albuquerque, New Mexico, United States, 87106 |
|Oregon Health & Science University
|Portland, Oregon, United States, 97239 |
|Austin, Texas, United States, 78759 |
Sanofi Pasteur, a Sanofi Company
||Sanofi Pasteur Inc
No publications provided
||Sanofi ( Sanofi Pasteur, a Sanofi Company )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 16, 2006
||January 17, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Immune System Diseases
DNA Virus Infections