A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
NCT ID: NCT00316602
Last Updated: 2019-01-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
632 participants
INTERVENTIONAL
2006-07-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Healthy Participants
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
IMVAMUNE
Subjects receiving two subcutaneous vaccinations
Atopic Dermatitis Participants
Vaccinia naive subjects with diagnosed Atopic Dermatitis. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD \[SCORAD\] \<= 30), receiving two doses of MVA-BN (IMVAMUNE)
IMVAMUNE
Subjects receiving two subcutaneous vaccinations
Interventions
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IMVAMUNE
Subjects receiving two subcutaneous vaccinations
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Subjects without present or history of any kind of atopy.
Group 2 (Atopic Dermatitis Participants):
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
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.
18 Years
40 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Bavarian Nordic
INDUSTRY
Responsible Party
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Principal Investigators
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Richard N Greenberg, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky School of Medicine
Locations
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Alta Clinical Research LLC
Tucson, Arizona, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Rx Clinical Research, Inc.
Garden Grove, California, United States
Solano Clinical Research
Vallejo, California, United States
Northwestern University
Chicago, Illinois, United States
Adult & Pediatric Dermatology PC
Overland Park, Kansas, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Saint Louis University
St Louis, Missouri, United States
Sundance Clinical Research
St Louis, Missouri, United States
Meridian Clinical Research
Omaha, Nebraska, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Dermatology Associates of Rochester
Rochester, New York, United States
Oregon Dermatology & Research Center
Portland, Oregon, United States
Dermatology Treatment & Research Center
Dallas, Texas, United States
Dermatology Clinical Research
San Antonio, Texas, United States
Hospital Juárez de México
Magdalena de las Salinas, CP, Mexico
Instituto Dermatologico de Jalisco "Dr. Jose Barba Rubio"
Guadalajara, Jalisco, Mexico
Hospital General de México
Mexico City, , Mexico
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
Hospital Angel Leañol, Dermatology
Zapopan, Jalisco, , Mexico
Countries
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References
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Greenberg RN, Hurley MY, Dinh DV, Mraz S, Vera JG, von Bredow D, von Krempelhuber A, Roesch S, Virgin G, Arndtz-Wiedemann N, Meyer TP, Schmidt D, Nichols R, Young P, Chaplin P. A Multicenter, Open-Label, Controlled Phase II Study to Evaluate Safety and Immunogenicity of MVA Smallpox Vaccine (IMVAMUNE) in 18-40 Year Old Subjects with Diagnosed Atopic Dermatitis. PLoS One. 2015 Oct 6;10(10):e0138348. doi: 10.1371/journal.pone.0138348. eCollection 2015.
Other Identifiers
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HHSN266200400072C
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
POX-MVA-008
Identifier Type: -
Identifier Source: org_study_id
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