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

This study has been completed.
Sponsor:
Information provided by:
Bavarian Nordic
ClinicalTrials.gov Identifier:
NCT00189943
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   20 Years to 55 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00189943     History of Changes
Other Study ID Numbers: MVA-POX-001, Bavarian Nordic
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Germany: Paul-Ehrlich-Institut

ClinicalTrials.gov processed this record on September 18, 2014