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

Bavarian Nordic

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Biological: IMVAMUNE

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00316602

POX-MVA-008

HHSN266200400072C

Details and patient eligibility

About

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.

Enrollment: 632 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Group 1 (Healthy Participants):

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

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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632 participants in 2 patient groups

Healthy Participants

Experimental group

Description:

Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)

Treatment:

Biological: IMVAMUNE

Atopic Dermatitis Participants

Experimental group

Description:

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)

Treatment:

Biological: IMVAMUNE