Immune response to flu vaccine in cancer patients taking idelalisib
Research type
Research Study
Full title
Immune Response to Influenza Vaccine in Subjects with B-cell Malignancies Treated with Idelalisib
IRAS ID
245711
Contact name
Silvia Montoto Almirall
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2017-003055-30
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 8 months, 29 days
Research summary
B-cell cancers are a type of cancer of the immune system that develops in infection-fighting white blood cells, called B-cell lymphocytes. Patients with these blood cancers frequently experience severe impairment of their body’s defence mechanism (immune system), either as a consequence of their disease, or as a result of the therapies during disease management and treatment. This in turn can lead to an increased risk of infections, especially of the respiratory tract, and cause significant morbidity and mortality.
Seasonal influenza is a serious health issue in some countries, and an annual vaccine is highly recommended in this patient population due to their increased risk of infection. The influenza vaccine introduces a strain(s) of weakened or inactivated flu virus into the recipient. The immune system is then able to produce antibodies (protein made in response to a foreign substance) against the introduced flu virus. In patients with functioning immunity, this process of active immunisation is an effective means of preventing influenza and associated complications. Currently, there is limited data on the immune response of patients following influenza vaccination.
Idelalisib is an approved medication for some kinds of B-cell cancers and has been approved for use in the United States, European Union, and several other regions. The aim of this study is to determine whether influenza vaccination is effective in eliciting a protective immune response in patients with B-cell cancers who are being treated with idelalisib.
22 participants will be enrolled into this study in approximately 25 sites globally. The approximate duration of the study will be 42 days. Only participants with the ability to provide informed consent and above the age of 18 years will be considered for recruitment.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0431
Date of REC Opinion
20 Jun 2018
REC opinion
Favourable Opinion