gB/MF59 Vaccine in Preventing Cytomegalovirus Infection in Healthy Adolescent Females
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this research study is to test the safety of and the body's response to an
experimental cytomegalovirus (CMV) vaccine (called gB/MF59 vaccine). Participants will
include approximately 400 healthy females, ages 12-17, recruited from adolescent clinics at
Cincinnati Children's Hospital Medical Center, Vanderbilt University Medical Center, Baylor
College of Medicine, University of Texas School of Public Health, Houston, and the University
of Texas Medical Branch at Galveston. Participants will receive 3 doses of vaccine or placebo
(saltwater) on a 0, 1, and 6 month schedule. Study procedures will include blood and urine
samples. Participants will complete a diary recording temperatures and any side effects
experienced. Subjects will be involved in study related procedures for up to 31 months.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)