MVA Post-Event: Administration Timing and Boost Study
Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate an investigational smallpox vaccine, called
IMVAMUNE®, with respect to safety and immune (body's defense system) response. Participants
will include healthy adults, age 18 or older born after 1971, who have not had smallpox
vaccine before. Volunteers were originally assigned to 1 of 5 groups. In July 2007, a hold
was placed on the Dryvax® groups and the study was modified. Volunteers, numbering 197, will
be assigned by chance to one of 3 groups to be vaccinated twice with IMVAMUNE® vaccine or
placebo (inactive substance) in Groups A and B, or to receive a single vaccination with
IMVAMUNE® or placebo in Group F. Volunteers will complete a memory aid (diary) for 15 days
following vaccination. Blood samples will be collected. Volunteers may participate for up to
425 days.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)