drugset / Trial / NCT00379938

B-19 Parvovirus Vaccine Study

NCT00379938

RandomizedParallel-groupDouble-blindPrevention

Summary

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.

Timeline

Start
2006-08
Primary completion
2008-10
Completion
2008-10

Drugs

EvaluationDrugModalityDoseRoute
Subject MF59 Other / unclassified
Subject VAI-VP705 Vaccine 2.5 ug
Subject VAI-VP705 Vaccine 25 ug