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A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT00316602
Recruitment Status : Completed
First Posted : April 21, 2006
Last Update Posted : October 12, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: MVA-BN® (IMVAMUNE) Biological: IMVAMUNE Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 632 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multicenter, Open-label, Controlled Phase II Study to Evaluate Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in 18-40 Year Old Subjects With Diagnosed Atopic Dermatitis
Study Start Date : July 2006
Primary Completion Date : November 2009
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Smallpox
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Biological: MVA-BN® (IMVAMUNE)
x
Experimental: 2 Biological: IMVAMUNE
x


Outcome Measures

Primary Outcome Measures :
  1. Seroconversion rate at visit 4 assessed by MVA-BN ELISA [ Time Frame: 42 days ]

Secondary Outcome Measures :
  1. Neutralisation assay specific seroconversion rates and geometric mean titres (at all blood sampling time points) [ Time Frame: 42 days ]
  2. ELISA specific seroconversion rates and geometric mean titres (at all blood sampling time points) [ Time Frame: 42 days ]
  3. Occurrence, relationship and intensity of any serious and/or unexpected adverse reaction at any time during the study [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Group 1:

Subjects without present or history of any kind of atopy.

Group 2:

Subjects with diagnosed atopic dermatitis.

All study subjects:

  1. Male and female subjects between 18 and 40 years of age without history of smallpox vaccination.
  2. Women must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours prior to vaccination.
  3. Women of childbearing potential must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the study, and must not become pregnant for at least 28 days after the last vaccination.
  4. Lab values without clinically significant findings.
  5. Electrocardiogram (ECG) without clinically significant findings.

Exclusion Criteria:

  1. Pregnant or breast-feeding women.
  2. Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
  3. History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
  4. Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
  5. History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer at the vaccination site are excluded.
  6. History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure.
  7. History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before age 50 years.
  8. Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool: (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof) NOTE: This criterion applies only to volunteers 20 years of age and older.
  9. History of anaphylaxis or severe allergic reaction.
  10. Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
  11. Administration of immunomodulatory substances.
Contacts and Locations

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): NCT00316602


Locations
United States, Arizona
Alta Clinical Research LLC
Tucson, Arizona, United States, 85745
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, California
Rx Clinical Research, Inc.
Garden Grove, California, United States, 92843
Solano Clinical Research
Vallejo, California, United States, 94589
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Kansas
Adult & Pediatric Dermatology PC
Overland Park, Kansas, United States, 66211
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536-0093
United States, Missouri
Saint Louis University
St. Louis, Missouri, United States, 63104
Sundance Clinical Research
St. Louis, Missouri, United States, 63141
United States, Nebraska
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106-5239
United States, New York
Dermatology Associates of Rochester
Rochester, New York, United States, 14623
United States, Oregon
Oregon Dermatology & Research Center
Portland, Oregon, United States, 97210
United States, Texas
Dermatology Treatment & Research Center
Dallas, Texas, United States, 75230
Dermatology Clinical Research
San Antonio, Texas, United States, 78229
Mexico
Hospital Juárez de México
Delagacion Gustavo A. Madero, CP, Mexico, 07760
Instituto Dermatologico de Jalisco "Dr. Jose Barba Rubio"
Guadalajara, Jalisco, Mexico
Hospital General de México
Mexico City, Mexico, 6760
CIFBIOTEC (Centro de Investigacion Farmacologica y Biotecnologica)
Mexico City, Mexico
Hospital Regional Lic. Adolfo Lopez Mateos. ISSSTE Ciudad de Mexico
Mexico City, Mexico
Centro Regional de Alergia e Inmunología Clínica del Hospital Universitario "Dr. José Eleuterio González"
Monterrey, Mexico, 64460
Hospital Angel Leañol, Dermatology
Zapopan, Jalisco, Mexico, 45200
Sponsors and Collaborators
Bavarian Nordic
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Richard N Greenberg, M.D. University of Kentucky School of Medicine
More Information

Publications:
Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT00316602     History of Changes
Other Study ID Numbers: POX-MVA-008
HHSN266200400072C ( Other Grant/Funding Number: NIAID )
First Posted: April 21, 2006    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

Keywords provided by Bavarian Nordic:
Atopic dermatitis
Smallpox
Vaccination

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
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