A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 40
Updated:1/5/2019
Start Date:February 2013
End Date:June 2014

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A Randomized, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-Naïve Subjects

A randomized, double-blind, placebo-controlled Phase III trial to evaluate immunogenicity and
safety of three consecutive production lots of IMVAMUNE® (MVA-BN®) smallpox vaccine in
healthy, vaccinia-naïve subjects.


Inclusion Criteria:

- Male and female subjects, 18 to 40 years of age

- The subject has read, signed and dated the informed consent form, 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 procedures

- BMI ≥ 18.5 and < 35

- Women of childbearing potential (WOCBP) 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 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 with a history of hysterectomy (Acceptable
contraception methods are restricted to abstinence, barrier contraceptives,
intrauterine contraceptive devices or licensed hormonal products)

- WOCBP must have a negative serum pregnancy test at screening and a negative urine
pregnancy test within 24 hours prior to each vaccination

- White blood cells ≥ 2,500/mm3 < ULN

- Absolute neutrophil count (ANC) within normal limits

- Hemoglobin within normal limits

- Platelets within normal limits

- Adequate renal function defined as a calculated Creatinine Clearance (CrCl) > 60
ml/min as estimated by the Cockcroft-Gault equation:

- For men: (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dl
x 72) = CrCl (ml/min)

- For women: multiply the result by 0.85 = CrCl (ml/min).

- Adequate hepatic function defined as:

- a. Total bilirubin ≤ 1.5 x ULN in the absence of other evidence of significant
liver disease

- b. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline
phosphatase ≤ 1.5 x ULN

- Troponin I < 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, AV 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

- Typical vaccinia scar

- Known or suspected history of smallpox vaccination

- History of vaccination with any poxvirus-based vaccine

- US Military service prior to 1991 or after January 2003

- Pregnant or breast-feeding women

- Uncontrolled serious infection, i.e. not responding to antimicrobial therapy

- History of any serious medical condition, which in the opinion of the investigator
would compromise the safety of the subject or would limit the subject's ability to
complete the trial

- 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,
HIV Infection, clinically significant liver disease (including chronic active HBV or
HCV), 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 must not be vaccinated at the previous tumor site

- History or clinical manifestation of clinically significant and severe hematological,
pulmonary, central nervous, cardiovascular or gastrointestinal disorders

- Clinically significant mental disorder not adequately controlled by medical treatment

- History of coronary heart disease, myocardial infarction, angina pectoris, congestive
heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high
blood pressure, or any other heart condition under the care of a doctor

- Known 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 subjects 20 years of age and older

- Active or history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse
(within the past 6 months)

- Known allergy to IMVAMUNE® vaccine and its constituents, e.g. tris
(hydroxymethyl)-amino methane, including know allergy to egg or aminoglycosides

- History of anaphylaxis or severe allergic reaction to any vaccine

- Acute disease (illness with or without a fever) at the time enrollment

- Body temperature ≥100.4°F (≥38.0°C) at the time of enrollment

- Having received any vaccinations or planned vaccinations with a live vaccine within 30
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

- Chronic systemic administration (defined as more than 14 days) of > 5 mg prednisone
(or equivalent)/day or any other immune-modifying drugs during a period starting from
three months prior to administration of the vaccine and ending at last physical trial
visit (V5)

- Post organ transplant subjects whether or not receiving chronic immunosuppressive
therapy

- 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 last physical trial visit (V5)

- Use of any investigational or non-registered drug or vaccine other than the trial
vaccine within 30 days preceding the first dose of the trial vaccine, or planned
administration of such a drug during the trial period

- Trial personnel
We found this trial at
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Bristol, Tennessee 37620
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
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400 Gresham Dr
Norfolk, Virginia 23507
757-627-7446
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6709 Waters Avenue
Savannah, Georgia 31406
888-737-7460
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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Augusta, Kansas 67010
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Birmingham, Alabama 35294
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Cleveland, Ohio 44122
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Colorado Springs, Colorado 80907
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Fort Worth, Texas 76135
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7261 Sheridan Street
Hollywood, Florida 33024
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Knoxville, Tennessee 37920
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Las Vegas, Nevada 89104
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Layton, Utah 84041
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Melbourne, Florida 23935
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Meridian, Idaho 83642
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Metairie, Louisiana 70006
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Mount Pleasant, South Carolina 29464
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Omaha, Nebraska 68134
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Peoria, Illinois 61602
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Portland, Oregon 97239
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Rochester, New York 14609
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San Diego, California 92123
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Springfield, Missouri 65802
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West Jordan, Utah 84088
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Wooster, Ohio 44691
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