MVA Post-Event: Administration Timing and Boost Study

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. Participants were originally assigned to 1 of 5 groups. In July 2007, a hold was placed on the Dryvax® groups and the study was modified. Participants, 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. Participants will complete a memory aid (diary) for 15 days following vaccination. Blood samples will be collected. Participants may participate for up to 425 days.

Timeline

Start

2007-04-16

Primary completion

2009-04-21

Completion

2009-04-21

Publications

• Results Frey SE, Winokur PL, Salata RA, El-Kamary SS, Turley CB, Walter EB Jr, Hay CM, Newman FK, Hill HR, Zhang Y, Chaplin P, Tary-Lehmann M, Belshe RB. Safety and immunogenicity of IMVAMUNE(R) smallpox vaccine using different strategies for a post event scenario. Vaccine. 2013 Jun 24;31(29):3025-33. doi: 10.1016/j.vaccine.2013.04.050. Epub 2013 May 9.

Drugs

Indications