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

Completed · Phase 3 · Has a placebo group

Conditions studied: Smallpox

In brief

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.

Key facts

Study ID: NCT01144637
Run by: Bavarian Nordic
People needed: 4005
Starts: 2013-02-01
Expected to finish: 2014-06-01
Last updated by the study team: 2019-01-03

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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)

You may not qualify if…

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)

Where it is running

Alabama Vaccine Research Clinic — Birmingham, Alabama, United States
Anaheim Clinical Trials — Anaheim, California, United States
National Research Institute — Los Angeles, California, United States
Northern California Clinical Research Center (NCCRC) — Redding, California, United States
Therapeutics Clinical Research — San Diego, California, United States
Lynn Institute of the Rockies — Colorado Springs, Colorado, United States
Avail Clinical Research, LLC — DeLand, Florida, United States
Broward Research Group — Hollywood, Florida, United States
Accelovance Melbourne — Melbourne, Florida, United States
Southeast Regional Research Group — Savannah, Georgia, United States
Advanced Clinical Research, Inc. — Meridian, Idaho, United States
Accelovance Peoria — Peoria, Illinois, United States
Heartland Research Associates — Augusta, Kansas, United States
Heartland Research Associates, LLC — Wichita, Kansas, United States
Benchmark Research — Metairie, Louisiana, United States
QPS Bio-Kinetic — Springfield, Missouri, United States
Washington University in St. Louis, School of Medicine — St Louis, Missouri, United States
Meridian Clinical Research, LLC — Omaha, Nebraska, United States
Clinical Research Center of Nevada, LLC — Las Vegas, Nevada, United States
Rochester Clinical Research, Inc. — Rochester, New York, United States
Wake Research Associates — Raleigh, North Carolina, United States
Rapid Medical Research, Inc. — Cleveland, Ohio, United States
Family Practice Center of Wooster — Wooster, Ohio, United States
Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
Columbia Research Group, Inc. — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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