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

NCT ID: NCT00189969

Last Updated: 2006-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2006-02-28

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.

Conditions

Smallpox

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Elstree-BN

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 32 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bavarian Nordic

INDUSTRY

Sponsor Role: lead

Principal Investigators

Andreas Schroedter, M.D.

Role: PRINCIPAL_INVESTIGATOR

Focus Clinical Drug Development GmbH

Locations

Focus Clinical Drug Development GmbH

Neuss, Nordrhein, Germany

Countries

Germany

Other Identifiers

POX-ELS-001

Identifier Type: -

Identifier Source: org_study_id