Study of Immune Responses to Influenza Vaccination With or Without Imiquimod Application in Untreated CLL Patients
Status:
Terminated
Trial end date:
2017-03-15
Target enrollment:
Participant gender:
Summary
The purpose of the study is to determine whether it is possible to improve the immune
response rate to 'flu vaccination in patients with chronic lymphocytic leukaemia (CLL).
Annual flu vaccination is recommended for all patients with CLL because they are known to be
susceptible to infections and particularly to chest infections that may occur as a
complication of influenza. Protection against 'flu depends on patients having a high level of
antibodies against the 'flu virus. Vaccination works by stimulating the immune system and
thus boosting the levels of these protective antibodies.
CLL patients have weakened immune systems due to the leukaemia itself but also following
chemotherapy. The exact cause of these immune defects is not known. However, CLL patients
typically have low antibody levels and their immune cells may not work normally.
Unfortunately, studies have shown that patients with CLL are not very good at making
antibodies to 'flu vaccination and as a result protection against flu is not very reliable.
Recent studies have shown that only 15-20 % of CLL patients will achieve a protective
antibody level.
Recently a new type of medical cream has been introduced to treat certain skin conditions.
Its name is Imiquimod and it is licensed to treat viral warts in the genital area and a type
of skin cancer called basal cell carcinoma. It works by increasing the immune response in the
skin. Animal studies have shown that as well as increasing immunity against viruses and
cancers, it increases responses to vaccination when applied at the site of vaccination.
In this study we propose to test whether this new medicine can improve the response to the
'flu jab.