This study investigates the safety and effectiveness of a preventative vaccine for parvovirus
B-19 infection. Eighty-nine healthy adults ages 18-49, whose blood tests negative for B-19,
will be enrolled. Participants will be randomly chosen to receive 1 of 4 possible vaccine
types: low dose of the vaccine and an adjuvant (substance which assists with transfer of
medication to body); high dose of the vaccine alone; high dose of the vaccine and an
adjuvant; or saline (substance containing no medication). Participants will receive 3
vaccinations over a 6 month period and will be followed for 6 additional months. Blood
samples will be taken at months 1, 2, 6, 7 and 12 to determine if antibody, protein produced
by the body's immune system that recognizes and helps fight infections, has been formed to
the vaccine. These tests measure vaccine efficacy, i.e., determine if the vaccine induces
immunity. All participants will be followed closely for safety throughout the study.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)