Back to resultsStudy on Safety, Tolerability and Immunogenicity of an MVA Vaccine Administered to Healthy Subjects
Primary Purpose
Smallpox
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
MVA-BN
Sponsored by
About this trial
This is an interventional prevention trial for Smallpox
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)
Sites / Locations
- PharmPlanNet Contract Research GmbH
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00189943
Brief Title
Study on Safety, Tolerability and Immunogenicity of an MVA Vaccine Administered to Healthy Subjects
Official Title
Phase I Study on Safety, Tolerability and Immunogenicity of the MVA-BN Vaccine Administered to Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bavarian Nordic
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smallpox
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
90 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
MVA-BN
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl M Eckl, MD
Organizational Affiliation
PharmPlanNet Cantract Research GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
PharmPlanNet Contract Research GmbH
City
Moenchengladbach
ZIP/Postal Code
41061
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Study on Safety, Tolerability and Immunogenicity of an MVA Vaccine Administered to Healthy Subjects
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