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

NCT00189969 | Completed Phase 1

• 1 other identifier: POX-ELS-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Occurrence of a typical pock ("take") which is associated historically with protection against variola within one week after vaccination.

Secondary Outcomes (3)

• 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.

• ELISA / Neutralisation assay specific seroconversion rates and geometric mean titres 2,4,12,52 and 104 weeks after vaccination.

• Interferone-gamma producing T cells 2,4,12,52 and 104 weeks after vaccination.

Interventions

Elstree-BN BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bavarian Nordic: lead

Study Sites (1)

Focus Clinical Drug Development GmbH

Neuss, Nordrhein, 41460, Germany

Location

MeSH Terms

Conditions

Smallpox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Andreas Schroedter, M.D.

  Focus Clinical Drug Development GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: September 1, 2003
• Study Completion: February 1, 2006
• Last Updated: April 21, 2006

Record last verified: 2006-04

Locations

DE (1)