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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00189943
First Posted: September 19, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bavarian Nordic
  Purpose
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 Intervention Phase
Smallpox Biological: MVA-BN Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bavarian Nordic:

Estimated Enrollment: 90
Study Start Date: April 2001
Estimated Study Completion Date: July 2003
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


Locations
Germany
PharmPlanNet Contract Research GmbH
Moenchengladbach, Germany, 41061
Sponsors and Collaborators
Bavarian Nordic
Investigators
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 Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: October 12, 2017
Last Verified: September 2005

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