Clinical trial NCT00316602: A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
Smallpox
Vaccination
Lead sponsor: Bavarian Nordic
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2006-04-21
Enrollment: 632
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Seroconversion by ELISA
timeFrame: week 6
Secondary outcomes:
measure: Percentage of Participants With Seroconversion by ELISA
timeFrame: within 32 weeks
measure: ELISA GMT
timeFrame: within 32 weeks
measure: Percentage of Participants With Seroconversion by PRNT
timeFrame: within 32 weeks
measure: PRNT GMT
timeFrame: within 32 weeks
measure: ELISPOT IFN-γ Values
timeFrame: within 6 weeks
measure: Number of Participants With SAEs
timeFrame: within 32 weeks
measure: Number of Participants With Related Grade >=3 Adverse Events
timeFrame: within 29 days after vaccination
measure: Number of Participants With Solicited Local Adverse Events
timeFrame: within 8 days after any vaccination
measure: Number of Participants With Solicited General AEs
timeFrame: within 8 days after any vaccination
measure: Number of Unsolicited Non-serious Adverse Events: Intensity
timeFrame: within 29 days after any vaccination
measure: Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
timeFrame: within 29 days after any vaccination
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Alta Clinical Research LLC
state: Arizona
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Garden Grove
country: United States
facility: Rx Clinical Research, Inc.
state: California
city: Vallejo
country: United States
facility: Solano Clinical Research
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Overland Park
country: United States
facility: Adult & Pediatric Dermatology PC
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Rochester
country: United States
facility: Dermatology Associates of Rochester
state: New York
city: Portland
country: United States
facility: Oregon Dermatology & Research Center
state: Oregon
city: Dallas
country: United States
facility: Dermatology Treatment & Research Center
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research
state: Texas
city: Magdalena De Las Salinas
country: Mexico
facility: Hospital Juárez de México
state: CP
city: Guadalajara
country: Mexico
facility: Instituto Dermatologico de Jalisco "Dr. Jose Barba Rubio"
state: Jalisco
city: Mexico City
country: Mexico
facility: Hospital General de México
city: Mexico City
country: Mexico
facility: CIFBIOTEC (Centro de Investigacion Farmacologica y Biotecnologica)
city: Mexico City
country: Mexico
facility: Hospital Regional Lic. Adolfo Lopez Mateos. ISSSTE Ciudad de Mexico
city: Monterrey
country: Mexico
facility: Centro Regional de Alergia e Inmunología Clínica del Hospital Universitario "Dr. José Eleuterio González"
city: Zapopan, Jalisco
country: Mexico
facility: Hospital Angel Leañol, Dermatology
Study officials:
affiliation: University of Kentucky School of Medicine
name: Richard N Greenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.