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

Bavarian Nordic

Status and phase

Completed

Phase 1

Conditions

Smallpox

Treatments

Biological: Elstree-BN

Study type

Interventional

Funder types

Industry

Identifiers

NCT00189969

POX-ELS-001

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 32 years old

Volunteers

Accepts Healthy Volunteers

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.