Trial record 4 of 12 for:    Open Studies | "Poxviridae Infections"

A Non-inferiority Trial to Compare MVA-BN® Smallpox Vaccine to ACAM2000®

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Bavarian Nordic
Sponsor:
Information provided by (Responsible Party):
Bavarian Nordic
ClinicalTrials.gov Identifier:
NCT01913353
First received: July 26, 2013
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

To demonstrate the efficacy of MVA-BN® by showing that vaccination prior to administration of ACAM2000® results in an attenuated take.


Condition Intervention Phase
Prevention in 18-40 Year Old Healthy Vaccinia-naïve Subjects
Biological: MVA BN®
Biological: ACAM2000
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: A Randomized, Open-label Phase III Non-inferiority Trial to Compare Indicators of Efficacy for MVA-BN® Smallpox Vaccine to ACAM2000® in 18-40 Year Old Healthy Vaccinia-naïve Subjects

Resource links provided by NLM:


Further study details as provided by Bavarian Nordic:

Primary Outcome Measures:
  • Comparison of the take in Group 1 versus the take in Group 2 The correct measurement of the lesion area will be confirmed by a blinded Independent Take Review Committee (ITRC). [ Time Frame: Day 6-8 and day 13-15, respectively and healing time up to 2 weeks after scarification with ACAM2000®. ]

    Comparison of the take in Group 1 versus the take in Group 2 using a composite endpoint measuring the area of lesion in mm² at day 6-8 and day 13-15, respectively and healing time (i.e. number of days until scab separates from the skin) after scarification with ACAM2000®.

    The correct measurement of the lesion area will be confirmed by a blinded Independent Take Review Committee (ITRC).



Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Two vaccinations each of 0.5 ml MVA BN ® vaccine will be administered 4 weeks apart (Day 0 and Day 28) followed by a single vaccination of ACAM2000® vaccine 4 weeks after the second MVA BN® vaccination (Day 56).
Biological: MVA BN®
Other Names:
  • IMVMAUNE
  • IMVANEX
Biological: ACAM2000
Active Comparator: Group 2
A single vaccination of ACAM2000® will be administered at Day 0.
Biological: ACAM2000

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male and female subjects, 18-40 years of age
  2. 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
  3. Acceptable medical history by screening evaluation and physical examination
  4. BMI greater or eaqual than 18.5 and samller than 35
  5. 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
  6. 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)
  7. Human Immunodeficiency Virus (HIV) antibody negative, hepatitis B surface antigen negative and negative antibody test to hepatitis C virus
  8. White blood cells greater or eaqual than 2500/mm3 and smaller than 11,000/mm3
  9. Hemoglobin within normal limits
  10. Platelets greater or eaqual than lower normal limits
  11. Adequate renal function defined as a calculated Creatinine Clearance (CrCl) greater than 60 ml/min as estimated by the Cockcroft-Gault equation
  12. Adequate hepatic function in the absence of other evidence of significant liver disease defined as:

    • Total bilirubin greater than 1.5 x Upper Limit Normal (ULN)
    • Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) greater than 1.5 x ULN
    • Alkaline Phosphatase (Alk Phos) greater than 1.5 x ULN
  13. Troponin I smaller than 2 x ULN
  14. 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:

  1. Pregnant or breast-feeding women
  2. Typical vaccinia scar
  3. Known or suspected history of smallpox vaccination defined as visible vaccination scar or documentation of smallpox vaccination or as reported by the subject
  4. History of vaccination with any poxvirus-based vaccine
  5. History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject
  6. 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
  7. Having had radiation or X-ray treatment (not routine X-rays) within the last 3 months
  8. Post organ and bone-marrow transplant subjects whether or not receiving chronic immunosuppressive therapy
  9. Eye surgery within 4 weeks prior to trial vaccination
  10. History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded
  11. Uncontrolled serious infection, i.e. not responding to antimicrobial therapy
  12. 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
  13. History of keloid formation
  14. History or clinical manifestation of severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders
  15. 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
  16. Chest pain (that is diagnosed as cardiac related) or trouble breathing on exertion
  17. 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
  18. 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
  19. Clinically significant psychological disorder not adequately controlled by medical treatment
  20. Active or history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse (within the past 6 months)
  21. History of anaphylaxis or any severe allergic reaction or serious adverse reaction to a vaccine
  22. Eczema of any degree or history of eczema
  23. 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
  24. People with chronic exfoliative skin disorders/conditions
  25. 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
  26. People with a tattoo that covers the vaccination injection area (preventing assessment of the area and interfering with a vaccination site photograph)
  27. Having received any vaccinations or planned vaccinations with a live vaccine within 28 days prior to or after trial vaccination
  28. Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior to or after trial vaccination
  29. 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
  30. 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
  31. Blood donation for the duration of the trial
  32. Acute disease (illness with or without a fever) at the time of enrollment
  33. Temperature ≥ 100.4°F (38.0°C) at the time of enrollment
  34. Known household contacts with, or occupational exposure (other than minimal contact) to any of the following:

    • Pregnant women
    • Children <12 months of age
    • People with eczema or a history of eczema
    • People with active AD or history of AD
    • People with chronic exfoliative skin disorders/conditions
    • People with active Varicella zoster, Herpes zoster, impetigo, uncontrolled acne, Darier's disease or any acute skin disorders of large magnitude, e.g., laceration requiring sutures, burn with areas greater than 2×2 cm
    • People with active or recent immunodeficiency disease or use of immunosuppressive medications, for example: have or take medication for HIV, AIDS, leukemia, lymphoma, or chronic liver problem, have or take medication for Crohn's disease, lupus, arthritis, or other immune disease; have had radiation or X-ray treatment (not routine X-rays) within the last 3 months; have ever had a bone-marrow or organ transplant (or take medication for that ); or have another problem that requires steroids, prednisone or a cancer drug for treatment
    • People having had eye surgery within the last 4 weeks
  35. 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)
  36. Known allergies to ACAM2000® and its diluents including polymyxin B sulfate, neomycin sulfate, and phenol
  37. Known allergies to vaccinia immunoglobulin (VIG) including thimerosal or previous allergic reaction to immunoglobulins
  38. Known allergies to cidofovir, sulfa drugs, or probenecid
  39. Trial personnel
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT01913353     History of Changes
Other Study ID Numbers: POX-MVA-006
Study First Received: July 26, 2013
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Smallpox
Vaccinia
Poxviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 28, 2014