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Dose-Finding Study to Evaluate Immunogenicity of Three Different Dose Levels of the IMVAMUNE (MVA-BN) Smallpox Vaccine.

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Bavarian Nordic
ClinicalTrials.gov Identifier:
NCT00189956
First received: September 11, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

The objective of the study is to find the optimal dose for the smallpox candidate vaccine IMVAMUNE (MVA-BN). For this purpose the study compares IMVAMUNE (MVA-BN) administered at three different dose levels.


Condition Intervention Phase
Smallpox
Biological: IMVAMUNE (MVA-BN)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Phase II, Double-Blind, Randomised, Dose-Finding Study to Evaluate the Immunogenicity of Three Different Doses of MVA-BN Smallpox Vaccine in 18-30 Year Old Smallpox naïve Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Bavarian Nordic:

Primary Outcome Measures:
  • ELISA specific seroconversion rate and geometric mean titres (at all blood sampling time points)

Secondary Outcome Measures:
  • Occurrence, relationship and intensity of adverse event at any time during the study

Estimated Enrollment: 165
Study Start Date: April 2003
  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects, aged 18 - 30 years
  • Signed informed consent after being advised of the risks and benefits of the study in a language able to understand, and prior to performance of any study specific procedure.
  • Free of obvious health problems with acceptable medical history by screening evaluation and physical examination.
  • Subject of not of child-bearing potential or all of the following: A urine/serum ß-HCG pregnancy test gives a negative result, use of adequate contraceptive precautions for 30 days before first vaccination.

Exclusion Criteria:

  • Known or suspected history of smallpox vaccination or typical vaccinia scar.
  • Positive test result in MVA specific ELISA or PRNT at screening.
  • Positive result in HIV or HCV antibody test at screening.
  • HbsAG positive at screening.
  • Pregnancy or breast-feeding.
  • Uncontrolled serious infection i.e. not responding to antimicrobial therapy
  • History of any serious medical condition, which in the opinion of the investigator, would compromise the safety of the subject.
  • History of autoimmune disease
  • History of malignancy.
  • History of chronic alcohol abuse and/or intravenous drug abuse.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • History of anaphylaxis or severe allergic reaction.
  • Acute disease (a moderate or severe illness with or without a fever) at the time of enrolment.
  • Any vaccinations within a period starting 30 days prior to administration of the vaccine and ending at study conclusion.
  • Chronic administration of immuno-suppressants or other immune-modifying drugs.
  • Administration or planned administration of immunoglobulins and/or any blood products during the study period.
  • Use of any investigational or non-registered drug or vaccine.
  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: NCT00189956

Locations
Switzerland
Swiss Pharma Contract
Basel, Switzerland, 4123
Sponsors and Collaborators
Bavarian Nordic
Investigators
Principal Investigator: Rolf Pokorny, M.D. Swiss Pharma
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00189956     History of Changes
Other Study ID Numbers: POX-MVA-004, NIH N01-AI-30016
Study First Received: September 11, 2005
Last Updated: September 11, 2005
Health Authority: United States: Food and Drug Administration
Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on November 23, 2014