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Take Rate, Immunogenicity and Safety of Elstree-BN Smallpox Vaccine in Healthy Vaccinia-Naive Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00189969
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : April 21, 2006
Information provided by:
Bavarian Nordic

Brief Summary:
The purpose of this study is to assess the take rate (formation of a typical postvaccinal lesion)and the safety and immunogenicity of the smallpox vaccine Elstree-BN.

Condition or disease Intervention/treatment Phase
Smallpox Biological: Elstree-BN Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase I Study to Evaluate Take Rate, Immunogenicity and Safety of Bavarian Nordic's Smallpox Vaccine Elstree-BN Administered to Healthy Vaccinia-Naive Subjects in the Age of 18-32 Years
Study Start Date : September 2003
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smallpox Vaccines

Primary Outcome Measures :
  1. Occurrence of a typical pock ("take") which is associated historically with protection against variola within one week after vaccination.

Secondary Outcome Measures :
  1. Occurrence, relationship and intensity of any serious adverse event at any time during the study / any non-serious adverse event within 4 weeks after vaccination.
  2. ELISA / Neutralisation assay specific seroconversion rates and geometric mean titres 2,4,12,52 and 104 weeks after vaccination.
  3. Interferone-gamma producing T cells 2,4,12,52 and 104 weeks after vaccination.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 32 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Signed informed consent
  • Free of obvious health problems
  • Negative HIV test
  • Negative hepatitis B surface antigen and negative antibody to hepatitis C virus
  • Hematocrit ≥ 38%; white blood cells between 4.0 and 10.0 / nl with differential blood count without clinical finding; and platelets between 150 and 400 / nl
  • ALT < 1.5 times institutional upper limit of normal
  • Negative urine glucose by dipstick or urinalysis
  • Adequate renal function defined as a serum creatinine < 1.5 mg/dL; urine protein < 100 mg/dL or < 2+ proteinuria; and a calculated creatinine clearance > 55 mL/min.
  • For women, negative pregnancy test at screening and within 24 hours prior to vaccination.
  • If the volunteer is female and of childbearing potential, she agrees to use acceptable contraception.

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Known or suspected history of smallpox vaccination
  • Typical vaccinia scar
  • Vaccinia specific antibodies at screening
  • History of immunodeficiency
  • Known or suspected impairment of immunologic function
  • Use of immunosuppressive medication or radiation therapy
  • Any history of atopic disease
  • Eczema of any degree or history of eczema
  • Chronic exfoliative skin disorders/conditions or any acute skin disorders of large magnitude
  • Any malignancy including leukemia or lymphoma
  • Presence of any infectious disease or a history or evidence of autoimmune disease
  • History or clinical manifestation of clinically significant mental illness or haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders
  • History of drug or chemical abuse
  • Administration of inactivated vaccine 14 days prior to vaccination
  • Any immune modifying therapy within 4 weeks prior to vaccination
  • Administration of live attenuated vaccines within 60 days prior to vaccination
  • Receipt of blood products or immunoglobulin in the past 6 months
  • Subjects with acute febrile illness within one week prior to vaccination or subjects who may be in the incubation period of an infectious disease
  • Household contacts/sexual contacts with, or occupational exposure to any of the following:

    1. Pregnant women
    2. Children <12 months of age
    3. People with current or history of atopic dermatitis
    4. People with chronic exfoliative skin disorders/conditions or any acute skin disorders
    5. People with immunodeficiency disease, malignancies or use of immunosuppressive medications
  • History of anaphylaxis or severe allergic reaction
  • Hypersensitivity to egg or chick protein
  • Known allergies to any component of the vaccine or its diluent
  • Known allergies to any known component of VIG
  • Known allergies to cidofovir or probenecid
  • Abnormalities suggestive of any underlying disease, detected at routine tests prior to study inclusion
  • Use of any investigational or non-registered drug or vaccine starting 30 days preceding the study vaccine and ending at conclusion visit
  • History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or other heart condition under the care of a doctor.
  • Three or more of the following risk factors: An immediate family member who has had onset of ischemic heart disease before age 50 years, elevated blood pressure, elevated blood cholesterol, diabetes or nicotine abuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00189969

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Focus Clinical Drug Development GmbH
Neuss, Nordrhein, Germany, 41460
Sponsors and Collaborators
Bavarian Nordic
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Principal Investigator: Andreas Schroedter, M.D. Focus Clinical Drug Development GmbH
Layout table for additonal information Identifier: NCT00189969    
Other Study ID Numbers: POX-ELS-001
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: April 21, 2006
Last Verified: April 2006
Additional relevant MeSH terms:
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Poxviridae Infections
DNA Virus Infections
Virus Diseases