A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Biological: IMVAMUNE
- Registration Number
- NCT00316602
- Lead Sponsor
- Bavarian Nordic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 632
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:
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy Participants IMVAMUNE Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE) Atopic Dermatitis Participants IMVAMUNE 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)
- Primary Outcome Measures
Name Time Method Percentage of Participants With Seroconversion by ELISA week 6 Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Seroconversion by ELISA within 32 weeks Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
ELISA GMT within 32 weeks Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.
PRNT GMT within 32 weeks Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.
Number of Participants With Related Grade >=3 Adverse Events within 29 days after vaccination Number of Participants with any Grade \>=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited (general) and unsolicited AEs.
Number of Participants With Solicited Local Adverse Events within 8 days after any vaccination Number of Participants with and Intensity of solicited local AEs (erythema, swelling and pain). Percentages based on subjects with at least one completed diary card.
Number of Unsolicited Non-serious Adverse Events: Intensity within 29 days after any vaccination Occurrence of unsolicited non-serious AEs by Intensity
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination within 29 days after any vaccination Occurrence of unsolicited non-serious AEs by relationship to study vaccine
Percentage of Participants With Seroconversion by PRNT within 32 weeks Seroconversion rate based on Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (15) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
ELISPOT IFN-γ Values within 6 weeks Number of interferon gamma (IFN-γ) secreting peripheral blood mononuclear cells (PBMC) per 10\^6 PBMC in response to restimulation with MVA-BN detected by ELISPOT assay
Number of Participants With Solicited General AEs within 8 days after any vaccination Number of Participants with solicited systemic/general AEs (elevated body temperature, headache, myalgia, nausea, fatigue and chills): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.
Number of Participants With SAEs within 32 weeks Occurrence, relationship and intensity of any serious AE (SAE)
Trial Locations
- Locations (22)
Adult & Pediatric Dermatology PC
🇺🇸Overland Park, Kansas, United States
Alta Clinical Research LLC
🇺🇸Tucson, Arizona, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Rx Clinical Research, Inc.
🇺🇸Garden Grove, California, United States
Solano Clinical Research
🇺🇸Vallejo, California, United States
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Sundance Clinical Research
🇺🇸Saint Louis, Missouri, United States
Meridian Clinical Research
🇺🇸Omaha, Nebraska, United States
Academic Dermatology Associates
🇺🇸Albuquerque, New Mexico, United States
Dermatology Treatment & Research Center
🇺🇸Dallas, Texas, United States
Dermatology Associates of Rochester
🇺🇸Rochester, New York, United States
Oregon Dermatology & Research Center
🇺🇸Portland, Oregon, United States
Dermatology Clinical Research
🇺🇸San Antonio, Texas, United States
Hospital Juárez de México
🇲🇽Magdalena De Las Salinas, CP, Mexico
Hospital Regional Lic. Adolfo Lopez Mateos. ISSSTE Ciudad de Mexico
🇲🇽Mexico City, 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
Centro Regional de Alergia e Inmunología Clínica del Hospital Universitario "Dr. José Eleuterio González"
🇲🇽Monterrey, Mexico
Hospital Angel Leañol, Dermatology
🇲🇽Zapopan, Jalisco, Mexico