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

Smallpox Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189969
• Other study ID #: POX-ELS-001
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: April 20, 2006
• Start date: September 2003
• Est. completion date: February 2006

Study information

• Verified date: April 2006
• Source: Bavarian Nordic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 32 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smallpox

Intervention

Biological:
• Elstree-BN

Locations

Country	Name	City	State
Germany	Focus Clinical Drug Development GmbH	Neuss	Nordrhein

Sponsors (1)

Lead Sponsor	Collaborator
Bavarian Nordic

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of a typical pock (“take”) which is associated historically with protection against variola within one week after vaccination.
Secondary	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.
Secondary	ELISA / Neutralisation assay specific seroconversion rates and geometric mean titres 2,4,12,52 and 104 weeks after vaccination.
Secondary	Interferone-gamma producing T cells 2,4,12,52 and 104 weeks after vaccination.