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

Sponsors and Collaborators:	Bavarian Nordic National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	Bavarian Nordic
ClinicalTrials.gov Identifier:	NCT00316602

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 II

MedlinePlus related topics: Smallpox

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	530
Study Start Date:	July 2006
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: MVA-BN® (IMVAMUNE) x
2: Experimental	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:

Male and female subjects between 18 and 40 years of age without history of smallpox vaccination.
Women must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours prior to vaccination.
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.
Lab values without clinically significant findings.
Electrocardiogram (ECG) without clinically significant findings.

Exclusion Criteria:

Pregnant or breast-feeding women.
Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
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.
History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure.
History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before age 50 years.
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.
History of anaphylaxis or severe allergic reaction.
Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
Administration of immunomodulatory substances.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316602

Show 21 Study Locations

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

Responsible Party:	Bavarian Nordic ( Monika Fluer )
Study ID Numbers:	POX-MVA-008, DMID 05-0133
Study First Received:	April 20, 2006
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00316602
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bavarian Nordic:

Atopic dermatitis
Smallpox
Vaccination

Study placed in the following topic categories:

Virus Diseases
Smallpox
Hypersensitivity
Dermatitis, Atopic
Poxviridae Infections
Genetic Diseases, Inborn

Skin Diseases
Hypersensitivity, Immediate
Skin Diseases, Eczematous
DNA Virus Infections
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009