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Study on Safety, Tolerability and Immunogenicity of an MVA Vaccine Administered to Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00189943
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 19, 2005
Information provided by:

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

Condition or disease Intervention/treatment Phase
Smallpox Biological: MVA-BN Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Phase I Study on Safety, Tolerability and Immunogenicity of the MVA-BN Vaccine Administered to Healthy Subjects
Study Start Date : April 2001
Estimated Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smallpox
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189943

PharmPlanNet Contract Research GmbH
Moenchengladbach, Germany, 41061
Sponsors and Collaborators
Bavarian Nordic
Principal Investigator: Karl M Eckl, MD PharmPlanNet Cantract Research GmbH
More Information

ClinicalTrials.gov Identifier: NCT00189943     History of Changes
Other Study ID Numbers: MVA-POX-001
Bavarian Nordic
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 19, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Poxviridae Infections
DNA Virus Infections
Virus Diseases