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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bavarian Nordic
ClinicalTrials.gov Identifier:
NCT00316602
First received: April 20, 2006
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Atopic Dermatitis
Biological: MVA-BN® (IMVAMUNE)
Biological: IMVAMUNE
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bavarian Nordic:

Primary Outcome Measures:
  • Seroconversion rate at visit 4 assessed by MVA-BN ELISA [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neutralisation assay specific seroconversion rates and geometric mean titres (at all blood sampling time points) [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • ELISA specific seroconversion rates and geometric mean titres (at all blood sampling time points) [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • Occurrence, relationship and intensity of any serious and/or unexpected adverse reaction at any time during the study [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 632
Study Start Date: July 2006
Study Completion Date: April 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: MVA-BN® (IMVAMUNE)
x
Experimental: 2 Biological: IMVAMUNE
x

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
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: 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 Regional Lic. Adolfo Lopez Mateos. ISSSTE Ciudad de Mexico
Mexico City, Mexico
CIFBIOTEC (Centro de Investigacion Farmacologica y Biotecnologica)
Mexico City, Mexico
Hospital General de México
Mexico City, Mexico, 6760
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
Investigators
Principal Investigator: Richard N Greenberg, M.D. University of Kentucky School of Medicine
  More Information

No publications provided

Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT00316602     History of Changes
Other Study ID Numbers: POX-MVA-008, DMID 05-0133
Study First Received: April 20, 2006
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bavarian Nordic:
Atopic dermatitis
Smallpox
Vaccination

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
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

ClinicalTrials.gov processed this record on July 20, 2014