Phase I Study on Safety, Tolerability and Immunogenicity of the MVA-BN Vaccine Administered to Healthy Subjects

Bavarian Nordic1 site in 1 country90 target enrollmentApril 2001

ConditionsSmallpox

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Smallpox
Sponsor: Bavarian Nordic
Enrollment: 90
Locations: 1
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to collect information on the safety, tolerability and immunogenicity of an investigational smallpox vaccine at different doses and using different routes of administration in vaccinia-naive and vaccinated healthy volunteers

Registry

clinicaltrials.gov

Start Date

April 2001

End Date

July 2003

Last Updated

20 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Bavarian Nordic

Eligibility Criteria

Inclusion Criteria

•Healthy male subjects, aged 20 - 55 years
•Signed informed consent

Exclusion Criteria

•Prior vaccination against smallpox (study part I only)
•Abnormalities suspicious of any underlying disease, detected at routine tests prior to study inclusion.
•Any immune modifying therapy within 4 weeks prior to entry
•Participation in any other investigating drug trial
•Known allergy to a component which may be part of the vaccine
•Allergic reaction or any other severe adverse effects experienced after previous smallpox vaccination (study Part II only)