Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
To demonstrate the efficacy of MVA-BN® in terms of vaccinia-specific Plaque Reduction Neutralization Test (PRNT) antibody response and by showing that vaccination prior to administration of ACAM2000® results in an attenuated take.
Full description
To demonstrate the efficacy of MVA-BN® by assessing non-inferiority of MVA-BN® compared to ACAM2000® in terms of vaccinia-specific Plaque Reduction Neutralization Test (PRNT) antibody response at the Peak Visits (Day 42 for Group 1 and Day 28 for Group 2) and by showing that vaccination with MVA-BN® prior to administration of ACAM2000® results in an attenuation of take.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Healthy male and female subjects, 18-42 years of age
The subject has read, signed and dated the Informed Consent, having been advised of the risks and benefits of the trial in a language understood by the subject and prior to performance of any trial specific procedure
Acceptable medical history by screening evaluation and physical examination
BMI greater or eaqual than 18.5 and smaller than 35
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening and a negative urine or serum pregnancy test within 24 hours prior to each vaccination
WOCBP must have used an acceptable method of contraception for 28 days prior to the first vaccination, must agree to use an acceptable method of contraception during the trial, and must avoid becoming pregnant for at least 28 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products)
Human Immunodeficiency Virus (HIV) antibody negative, hepatitis B surface antigen negative and negative antibody test to hepatitis C virus
White blood cells greater or eaqual than 2500/mm3 and smaller than 11,000/mm3
Hemoglobin within normal limits
Platelets greater or eaqual than lower normal limits
Adequate renal function defined as a calculated Creatinine Clearance (CrCl) greater than 60 ml/min as estimated by the Cockcroft-Gault equation
Adequate hepatic function in the absence of other evidence of significant liver disease defined as:
Troponin I smaller than 2 x ULN
Electrocardiogram (ECG) without clinically significant findings, e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, atrioventricular node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, two premature ventricular contractions in a row, ST elevation consistent with ischemia
Exclusion criteria
Pregnant or breast-feeding women
Typical vaccinia scar
Known or suspected history of smallpox vaccination defined as visible vaccination scar or documentation of smallpox vaccination or as reported by the subject
History of vaccination with any poxvirus-based vaccine
History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject
History of or active immunodeficiency or immunosuppression caused by acquired or congenital diseases or caused by ongoing treatments such as chronic (greater than 14 days) high-dose corticosteroids (smaller than 5 mg prednisone [or equivalent] per day applied systemically, i.e. parenterally or orally), chronic or planned treatment with steroid eye drops or ointment at time of enrollment or radiation, or immunosuppressive drugs; low-dose corticosteroid topical products and nasal sprays used sporadically, i.e. pro re nata (according to circumstances) are permissible
Having had radiation or X-ray treatment (not routine X-rays) within the last 3 months
Post organ and bone-marrow transplant subjects whether or not receiving chronic immunosuppressive therapy
Eye surgery within 4 weeks prior to trial vaccination
History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded
Uncontrolled serious infection, i.e. not responding to antimicrobial therapy
History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision considered to have achieved cure. Subjects with history of skin cancer must not be vaccinated at the previous site of cancer
History of keloid formation
History or clinical manifestation of severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders
History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor
Chest pain (that is diagnosed as cardiac related) or trouble breathing on exertion
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 NOTE: This criterion applies only to subjects 20 years of age and older
History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before the age of 50 years
Clinically significant psychological disorder not adequately controlled by medical treatment
Active or history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse (within the past 6 months)
History of anaphylaxis or any severe allergic reaction or serious adverse reaction to a vaccine
Eczema of any degree or history of eczema
People with active atopic dermatitis (AD) [characterized by pruritus, eczematous lesions, xerosis (dry skin), and lichenification (thickening of the skin and an increase in skin markings] or with a history of AD
People with chronic exfoliative skin disorders/conditions
People with active current Varicella zoster, Herpes zoster, impetigo, uncontrolled acne, Darier's disease or any acute skin disorders of large magnitude, e.g., laceration requiring sutures
People with a tattoo that covers the vaccination injection area (preventing assessment of the area and interfering with a vaccination site photograph)
Having received any vaccinations or planned vaccinations with a live vaccine within 28 days prior to or after trial vaccination
Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior to or after trial vaccination
Administration or planned administration of immunoglobulins and/or any blood products during a period starting from three months prior to administration of the vaccine and ending at trial conclusion
Use of any investigational or non-registered drug or vaccine other than the trial vaccines within 28 days preceding the first dose of the trial vaccine or planned administration of such a drug /vaccine during the trial period
Blood donation for the duration of the trial
Acute disease (illness with or without a fever) at the time of enrollment
Temperature ≥ 100.4°F (38.0°C) at the time of enrollment
Known household contacts with, or occupational exposure (other than minimal contact) to any of the following:
Known allergy to MVA-BN® vaccine or any of its constituents, e.g. tris(hydroxymethyl)-amino methane, including known allergy to egg or aminoglycoside (gentamycin)
Known allergies to ACAM2000® and its diluents including polymyxin B sulfate, neomycin sulfate, and phenol
Known allergies to vaccinia immunoglobulin (VIG) including thimerosal or previous allergic reaction to immunoglobulins
Known allergies to cidofovir, sulfa drugs, or probenecid
Trial personnel
Primary purpose
Allocation
Interventional model
Masking
440 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal