Inflammatory Bowel Disease (IBD) Clinical Trial
Official title:
Impact of Immunosuppression in Patients With Inflammatory Bowel Disease on Responsiveness to Influenza Vaccine
The purpose of this study is to compare the efficacy and safety of influenza vaccine in patients with inflammatory bowel disease (IBD) on immunosuppressive therapy with IBD patients on aminosalicylates and healthy historical controls.
Influenza is an extremely contagious airborne disease caused by influenza viruses. It can
cause mild to severe illness, and even death. Patients who have inflammatory bowel disease
(IBD) have a higher risk of getting serious complications if they are infected. Current
guidelines recommend the influenza vaccine for IBD patients. However, many IBD patients take
immunosuppressive agents and we are uncertain as to their capacity to mount a truly
protective response after vaccination. This is an important area of research because if IBD
patients do not have an adequate immunological response, then we may need to enhance their
response by increasing the dosage or giving booster shots.
Many clinicians who treat patients with autoimmune diseases are asking if the vaccine is
safe and effective. Many IBD patients will receive the vaccine without proper studies being
performed to answer these questions. The study we are proposing has important clinical and
public health significance. It is a step toward answering the question whether vaccination
with the influenza vaccine is safe in patients with IBD and if patients on different types
of immunosuppressive medications respond similarly and if they respond as well as healthy
controls to the vaccine. There are more than one million people in the United States who
have been diagnosed with IBD. Thus, the information gained from this clinical study will
provide important knowledge to physicians caring for immunocompromised patients who are
considering vaccination.
Studies on the immunological response of immunocompromised patients (e.g., transplant, HIV,
oncology, chronic renal failure, SLE) to the influenza vaccine have demonstrated that some
of these patients develop antibody titers at a protective level within 4-6 weeks. However,
the titers were decreased compared to healthy controls, especially if the immunocompromised
patients were on immunosuppressive agents. The frequency of influenza in immunocompromised
patients was lower after immunization and there were almost no major side effects from the
vaccine.
There is little data on immune response to vaccination in children with IBD. One recently
published study compared influenza titers before and after vaccination among 3 pediatric
groups: IBD patients who received immunosuppressive therapy, IBD patients who did not
receive immunosuppressive therapy, and healthy controls. All IBD patients in the study had a
decrease in response to one of three influenza strains when compared to controls. IBD
patients who received both immunomodulators and infliximab had a lower immune response rate
to two influenza strains when compared to controls. There was no difference in immune
response among IBD patients on immunomodulators only, IBD patients on ASA, and controls.
There was no difference in rates of adverse events between IBD patients and controls
The primary aim of this research are to measure seroprotection in IBD patients who are on or
off immunosuppressive agents after receiving the influenza vaccine. The hypothesis is that
IBD patients on immunosuppression have impaired immunity, and therefore, will have a lower
seroprotection rate after immunization compared to IBD patients not on immunosuppression. If
data is available, we will also compare each group to historical healthy controls given the
same vaccine. The secondary aims are to determine the antibody titer levels and side effects
these patients have.
The patient population includes IBD patients who are off immunosuppression and IBD patients
who are on immunosuppression. Recruiting approximately 75 patients per group will provide
adequate power for the study. A blood sample will be taken from all IBD patients to evaluate
baseline antibody levels and markers (e.g., CBC, ESR, albumin) before or immediately after
immunization with the influenza vaccine. Lab tests will be redrawn at Month 1 (3-8 weeks) to
evaluate the level of antibody titers and follow the markers. During the study, we will
track basic laboratory measures, disease status by using the Pediatric Crohn's Disease
Active Index or Modified Harvey-Bradshaw Score for UC, side effects and adverse events from
the vaccinations.
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