Safety, Reactogenicity and Immunogenicity of MVA in Hematopoietic Stem Cell Transplant (HSCT) Subjects
Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to compare how the body's immune system reacts to a vaccine
against smallpox infection, called Modified Vaccinia Ankara (MVA) and to evaluate the safety
of this vaccine. Study participants will include 24 adults, ages 18-60 years, who have
undergone a stem cell transplant more than 2 years ago. Study procedures will include a
physical exam, blood samples, heart activity assessments, and urine samples. Participants
will be assigned to 1 of 2 possible study vaccine groups. The participants will receive 1 of
2 possible vaccine doses or placebo (substance containing no medication) 28 days apart.
Participants will make at least 8 visits to the clinic during the course of the study;
additional visits may be needed if the participant experiences side effects from the vaccine.
Participants may be involved in study related procedures for about 6 months.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)