Status:
COMPLETED
Take Rate, Immunogenicity and Safety of Elstree-BN Smallpox Vaccine in Healthy Vaccinia-Naive Subjects
Lead Sponsor:
Bavarian Nordic
Conditions:
Smallpox
Eligibility:
All Genders
18-32 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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:
- Pregnant women
- Children \<12 months of age
- People with current or history of atopic dermatitis
- People with chronic exfoliative skin disorders/conditions or any acute skin disorders
- 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.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00189969
Start Date
September 1 2003
End Date
February 1 2006
Last Update
April 21 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Focus Clinical Drug Development GmbH
Neuss, Nordrhein, Germany, 41460