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
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
Poxviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 17, 2014