Trial Information

Evaluation of Pandemic H1N1(2009) Influenza Vaccine in Adults With Lymphoid Malignancies on Active Systemic Treatment or Post Stem Cell Transplantation

The novel influenza H1N1 virus responsible for a world-wide pandemic throughout 2009
(H1N1(2009)) is expected to cause a second wave of infection during the 2009/10 winter
season. Vaccines against H1N1(2009) will be available in early November, 2009. Adults with
hematologic disorders are at high risk of influenza-related complications, including death.
Given that the vaccination dosing for the pandemic vaccine has been developed on healthy
individuals, it is unknown whether this subgroup of patients will respond similarly. We
will evaluate the safety and efficacy of the pandemic vaccine in patients with lymphoid
malignancies receiving active systemic treatment, or who have recently undergone stem cell
transplantation. Patients will be randomized to one or two doses of the approved
adjuvanted vaccine; immune responses will be measured to identify the optimal regimen. Also,
we will look for an association between biomarkers of the immune system and a response to
the vaccine; this will be done by measuring baseline CD3, 4, 8, 19, and 56 cells by flow
cytometry.