take rate, immunogenicity and safety of elstree-bn smallpox vaccine in healthy vaccinia-naive subjects

Conditions: Smallpox

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 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 \ 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.