A Randomized Phase II Trial to Determine Whether the Application of Imiquimod Cream to the Vaccination Site Can Improve the Immune Responsiveness to Influenza Vaccination in Patients With Untreated Chronic Lymphocytic Leukemia
68 patients with stage A CLL who have not been treated, and 34 healthy age and sex matched
volunteers who fulfil the entry requirements will be identified and invited to take part in
Blood samples will be taken for baseline studies [FBC, U&E, LFT, Immunoglobulins (Igs),
haemagglutinin titres] (20 mls) and T cells studies (50 mls to be frozen).If CLL prognostic
factors have not already been determined a further 20ml will be taken for these.
Patients will be randomized to either:
Group A Vaccination with current trispecific influenza vaccine Day 1
Group B Vaccination with current trispecific influenza vaccine Day 1, together with the
application of Imiquimod cream to the vaccination site on day 2 to 6.
Blood samples will be taken on day 0 for haemagglutinin studies (20 ml) and T cells (50ml to
be frozen), then on day 7, 14 for T-cell studies (50 ml) and day 28 for haemagglutinin
studies (20 ml). During the 28 days that subjects participate in the trial approximately 190
ml will be taken in total.
Antibody and T-cell responses to influenza virus will be assessed and compared between the
two patient arms of the study and the control group.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
Immune responses to influenza vaccine in CLL cohorts and healthy age matched controls
Helen McCarthy, MBBS PhD
Royal Bournemouth Hospital
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Eudract number: 2006-004902-16