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 - Version 4
Influenza is a common respiratory infection caused by viruses. Standard influenza vaccines
may not be as effective at protecting cancer patients as the general population from getting
influenza. New technology has been developed that allows stronger (and hopefully more
effective) influenza vaccines to be developed. This research study will test an experimental
If you agree to take part in this study, you will be randomly assigned (as in the toss of a
coin) to receive either standard inactivated influenza vaccine or one of three doses of the
experimental vaccine. You will have an equal chance of being assigned to any of the four
treatment groups. Neither your physician, the study doctor, or you will know which vaccine
or dose you received. In case of an emergency, the study doctor can find out which vaccine
and dose you received.
Before the injection is given, a blood test will be taken to measure your antibodies
(substances that fight infection). About two teaspoons of blood will be taken for this
blood test. The vaccine will be given as a one time injection in the arm. After you are
given the injection, you will be observed for 20 minutes in the clinic before you are sent
home. Everyone taking part in this study will be asked to keep a symptom diary and
temperature log for 1 week after the injection. After 7 days, you will return for review of
the diary and any symptoms you may have had.
At 4 and 8 weeks after the influenza vaccine is given, most patients will have a blood test
to learn the amount of immunity against the influenza virus they have developed. About
two teaspoons of blood will be required for this test. A few patients may not be eligible
for the eight week blood collection and will be instructed by the study nurse about future
visits to UTMDACC. Six months after you have received the vaccine, you will be contacted by
one of the study personnel to ask you if you had any serious side effects that might be from
the study vaccine. Once you have received this follow-up telephone call, your
participation in this study will be completed.
This is an investigational study. The standard vaccine used in this study is FDA approved
and commercially available. The experimental vaccine is authorized for use in research only.
About 100 patients will take part in this study. All will be enrolled at UTMDACC.
This protocol is partially funded by a research contract from the National Institutes of
Health (NIH) to Baylor College of Medicine.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Immunogenic response across patients administered either licensed trivalent inactivated influenza vaccine (TIV) or one of three doses (15, 45 or 135 μg) of trivalent recombinant baculovirus expressed hemagglutinin vaccines.
Amar Safdar, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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