Title

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

    Phase 1
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    mva-bn ...
  • Study Participants

    90
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
Study Started
Apr 30
2001
Study Completion
Jul 31
2003
Last Update
Sep 19
2005
Estimate

Biological MVA-BN

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)
No Results Posted