A Randomized, Double-Blind, Placebo-Controlled Study on Immunogenicity and Safety of MVA-BN (IMVAMUNE™) Smallpox Vaccine in Healthy Subjects
The primary objective of this study is to evaluate the immune response after a single vaccination of pre-immune subjects compared to two vaccinations in naive subjects.
In addition the study further investigates the safety profile of MVA-BN® in a healthy population compared to placebo.
|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:||A Partially Randomized, Partially Double-Blind, Placebo-Controlled Phase II Non-Inferiority Study to Evaluate Immunogenicity and Safety of One and Two Doses of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in 18-55 Year Old Healthy Subjects|
- MVA-specific seroconversion rate derived from the ELISA specific antibody titers 2 weeks after the last vaccination [ Time Frame: 16 months ] [ Designated as safety issue: No ]
- To compare the four different vaccination groups with regard to ECG changes and cardiac symptoms [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2006|
|Study Completion Date:||August 2007|
Biological: MVA-BN® (IMVAMUNE)
2 immunizations: 1 x 10E8_TCID
1x 10E8_TCID50, 1x Placebo
Placebo Comparator: 3
2 x Placebo
1 immunization: 1x 10E8_TCID50
The study consists of 4 groups, which receive either MVA-BN once, MVA-BN two times, MVA-BN followed by placebo, or two administrations of placebo.
|Harrison Clinical Research GmbH|
|Munich, Bavaria, Germany, 80636|
|Principal Investigator:||Frank von Sonnenburg, Prof||Section of International Medicine & Public Health, Department of Infectious Diseases and Tropical Medicine, Ludwig-Maximilians Unviersity Munich|