The purpose of this research is to compare the ability of a new investigational smallpox
vaccine called IMVAMUNE® to produce a strong immune response against smallpox disease if
given as one single, higher dose compared with two lower doses given one month apart. Another
purpose of the study is to see how quickly someone might be protected against smallpox.
Volunteers will be vaccinia-naïve adults age 18 and older (born after 1971) divided into 2
groups. Volunteers in Group A will receive a high dose of vaccine given in 2 shots on day 0
followed by a placebo (inactive substance) shot on day 28. Group B will receive the standard
dose of vaccine and placebo given in 2 shots on day 0 followed by a standard dose shot on Day
28. Study participation will include 10 planned study visits over approximately 7 months.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)