At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of the Safety and Immunogenicity of Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid Formulation IMVAMUNE® (1x10^8 TCID50) Administered by the Subcutaneous Route and a Lower Dose Liquid Formulation IMVAMUNE® (2x10^7 TCID50) Administered by the Intradermal Route in Healthy Vaccinia-Naïve Individuals
In Brief
A Phase 2 clinical trial evaluating MVA Smallpox Vaccine for Smallpox. Completed, enrolled 523 participants across 8 sites.
Detailed Summary
Due to recent concern of biowarfare and bioterrorism, the US government is making efforts to improve its ability to protect citizens against the smallpox virus. This study will evaluate safety of IMVAMUNE®, an investigational smallpox vaccine, and its ability to stimulate the immune system (the body's defense system). Two vaccine preparations have the same name but one is a liquid and one is a powder that has liquid added just before it is given. The vaccine that comes as a liquid will be injected (given as a shot) just under the skin (subcutaneously) or injected between the layers of the skin (intradermally). The powder formulation is only injected just under the skin. Approximately 495 adults, age 18 older born after 1971, which have not had smallpox vaccine before, may participate in the study for about 7 months.
Study Details
Timeline
Interventions
Vaccinia vaccine liquid formulation delivered by subcutaneous (SC) route at 1x10\^8 TCID50 per 0.5 mL dose on Days 0 and 28.
Vaccinia vaccine liquid formulation delivered at lower dose \[2x10\^7 tissue culture infectious dose 50 (TCID50) per 0.1 mL dose\] by intradermal (ID) route on Days 0 and 28.
Vaccinia vaccine lyophilized formulation delivered by subcutaneous (SC) route at 1x10\^8 TCID50 per 0.5 mL dose on Days 0 and 28.