Status:
COMPLETED
Dose-finding Study to Evaluate Immunogenicity of Three Different Dose Levels of the IMVAMUNE (MVA-BN) Smallpox Vaccine.
Lead Sponsor:
Bavarian Nordic
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Smallpox
Eligibility:
All Genders
18-30 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00189956
Start Date
April 1 2003
End Date
December 1 2005
Last Update
January 10 2019
Active Locations (1)
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1
Swiss Pharma Contract
Basel, Switzerland, 4123