An Open-label, Controlled Phase I Pilot Study to Evaluate Safety and Immunogenicity of MVA-BN® Smallpox Vaccine in 18-40 Year Old Vaccinia-naïve Subjects With Atopic Disorders

Bavarian Nordic1 site in 1 country60 target enrollmentApril 2004

ConditionsDermatitis, Atopic Hay Fever

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Dermatitis, Atopic
Sponsor: Bavarian Nordic
Enrollment: 60
Locations: 1
Primary Endpoint: Occurrence, relationship and intensity of any serious adverse event at any time during the study.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in populations with atopic disorders.

Registry

clinicaltrials.gov

Start Date

April 2004

End Date

December 2005

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bavarian Nordic

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All subjects
•Read, signed and dated informed consent.
•Women of childbearing potential must use an acceptable method of contraception
•Group 1: Healthy subjects
•No history of atopic dermatitis as documented in the patient file
•No active atopic dermatitis
•No other atopic disorders such as asthma or allergic rhinitis.
•Prick test without clinical significance
•IgE within normal range
•Group 2: Subjects with history of atopic dermatitis

Exclusion Criteria

•Known or suspected history of smallpox vaccination or typical vaccinia scar.
•Positive test result in MVA specific ELISA at screening.
•Positive result in HIV or HCV antibody test at screening.
•Surface antigen of Hepatitis B Virus (HBsAg) positive at screening.
•Pregnant or breast-feeding women.
•Positive pregnancy test at screening and/or within 24 hours prior to vaccination.
•Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the institutional upper limit of normal.
•Positive urine glucose by dipstick or urine analysis.
•Inadequate renal function defined as a serum creatinine above the institutional upper limit of normal; urine protein \>30 mg/dl or trace proteinuria (by urine analysis or dipstick); and a calculated creatinine clearance \<80 ml/min.
•Electrocardiogram (ECG) with clinical significance.

Outcomes

Primary Outcomes

Occurrence, relationship and intensity of any serious adverse event at any time during the study.

Secondary Outcomes

ELISA specific seroconversion rates and geometric mean titres (at all blood sampling time points).
Neutralisation assay specific seroconversion rates and geometric mean titres (at all blood sampling time points).