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

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

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.

Study Overview

• Status: Completed
• Conditions: Smallpox
• Intervention / Treatment: Biological: Elstree-BN

• Study Type: Interventional
• Enrollment: 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Nordrhein
    • Neuss, Nordrhein, Germany, 41460
      • FOCUS Clinical Drug Development GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 32 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.
ELISA / Neutralisation assay specific seroconversion rates and geometric mean titres 2,4,12,52 and 104 weeks after vaccination.
Interferone-gamma producing T cells 2,4,12,52 and 104 weeks after vaccination.

Collaborators and Investigators

• Sponsor: Bavarian Nordic
• Investigators: Principal Investigator: Andreas Schroedter, M.D., FOCUS Clinical Drug Development GmbH

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Study Completion: February 1, 2006

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): April 21, 2006
• Last Update Submitted That Met QC Criteria: April 20, 2006
• Last Verified: April 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Poxviridae Infections; Smallpox; Vaccinia
• Other Study ID Numbers: POX-ELS-001