Evaluation of the Reactogenicity and Immunogenicity of Different Doses of Trivalent Baculovirus-expressed Influenza HA Vaccine in Adults With Non-Hodgkin's B-cell Lymphoma: A Phase II, Double-Blind Pilot Study
Influenza is a common respiratory infection caused by viruses. Epidemics of influenza occur
each winter and are responsible for more than 20,000 deaths each year in the United States.
Most of these deaths occur among elderly persons and among people of all ages who suffer
from a chronic disease. Standard influenza vaccines may not be as effective at protecting
cancer patients as the general population from getting influenza. This research study will
test an experimental influenza vaccine consisting of the important flu virus protein that
stimulates protection. It is produced by genetic techniques in cultured cells and allows
higher doses of the protein to be used. Influenza vaccines made this way have been given to
humans in the past and the vaccine was well tolerated. It is expected that higher doses of
this vaccine can be given with minimal reactions, as well as whether such a vaccine
stimulates higher levels of infection-fighting proteins (or antibodies) in the blood than
standard doses of the licensed influenza vaccine. This study will evaluate the
reactogenicity and immunogenicity of a recombiant influenza vaccine in non-Hodgkin's B cell
lymphoma.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
United States: Federal Government
04-036
NCT00307177
August 2004
April 2005
Name | Location |
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University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |