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

This study has been completed.
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Bavarian Nordic Identifier:
First received: September 11, 2005
Last updated: February 3, 2015
Last verified: February 2015

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
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 (Subject, Caregiver, Investigator, Outcomes Assessor)
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) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence, relationship and intensity of adverse event at any time during the study [ Designated as safety issue: Yes ]

Enrollment: 165
Study Start Date: April 2003
Study Completion Date: November 2003
Arms Assigned Interventions
Active Comparator: Group 1
healthy, vaccinia naïve subjects 2 x 10E7 TCID50 IMVAMUNE (MVA-BN), subcutaneous
Biological: IMVAMUNE (MVA-BN)
Two vaccinations of 0.5 ml MVA-BN vaccine, separated by a 4 week interval.
Active Comparator: Group 2
healthy, vaccinia naïve subjects 5 x 10E7 TCID50 IMVAMUNE (MVA-BN), subcutaneous
Biological: IMVAMUNE (MVA-BN)
Two vaccinations of 0.5 ml MVA-BN vaccine, separated by a 4 week interval.
Active Comparator: Group 3

healthy, vaccinia naïve subjects

1 x 10E8 TCID50 IMVAMUNE (MVA-BN), subcutaneous

Biological: IMVAMUNE (MVA-BN)
Two vaccinations of 0.5 ml MVA-BN vaccine, separated by a 4 week interval.


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

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.
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Please refer to this study by its identifier: NCT00189956

Swiss Pharma Contract
Basel, Switzerland, 4123
Sponsors and Collaborators
Bavarian Nordic
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Rolf Pokorny, M.D. Swiss Pharma
  More Information

Responsible Party: Bavarian Nordic Identifier: NCT00189956     History of Changes
Other Study ID Numbers: POX-MVA-004, NIH N01-AI-30016
Study First Received: September 11, 2005
Last Updated: February 3, 2015
Health Authority: United States: Food and Drug Administration
Switzerland: Swissmedic

Additional relevant MeSH terms:
Blood Group Incompatibility
Brain Diseases
Brain Diseases, Metabolic
Central Nervous System Diseases
DNA Virus Infections
Erythroblastosis, Fetal
Hematologic Diseases
Immune System Diseases
Infant, Newborn, Diseases
Metabolic Diseases
Nervous System Diseases
Pathologic Processes
Poxviridae Infections
Virus Diseases processed this record on October 08, 2015