The main purpose of this study is to test the safety of a new vaccine, STEBVax, which may
lead to a useful treatment for toxic shock syndrome. The second purpose is to determine
whether STEBVax causes the body to produce antibodies (proteins that fight infection) to help
the body resist disease. Researchers expect STEBVax shots will cause the development of
antibodies in the blood. Study participants will include up to 42 healthy adults, ages 18-40,
from the University of Maryland Baltimore community. Participants will be assigned to one of
7 vaccine dose groups. Assignment to dosage groups will depend on when individuals are
enrolled in the study. Study procedures will include blood sampling, urine collection, and
physical examinations. Subjects will maintain a memory aid documenting daily oral
temperatures and possible vaccine side effects. Participants will be involved in study
related procedures for up to 201 days.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)