Overview

This trial is active, not recruiting.

Condition chronic lymphocytic leukemia
Treatments imiquimod cream, influenza vaccine
Phase phase 2
Sponsor The Royal Bournemouth Hospital
Collaborator CLL Topics, Inc.
Start date October 2007
End date December 2013
Trial size 102 participants
Trial identifier NCT00596336, Eudract number: 2006-004902-16, LREC number: 06/Q2201/143

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Vaccination with current trispecific influenza vaccine Day 1
influenza vaccine influvac sub-unit
trispecific influenza vaccine 0.5 ml subcutaneously
(Experimental)
Vaccination with current trispecific influenza vaccine Day 1, together with the application of Imiquimod cream to the vaccination site on day 2 to 6.
imiquimod cream Aldara cream
Imiquimod (aldara) 0.5 % cream to site of vaccination on day 2 to 6
influenza vaccine influvac sub-unit
trispecific influenza vaccine 0.5 ml subcutaneously
(Active Comparator)
Vaccination with current trispecific influenza vaccine Day 1
influenza vaccine influvac sub-unit
trispecific influenza vaccine 0.5 ml subcutaneously

Primary Outcomes

Measure
Immune responses to influenza vaccine in CLL cohorts and healthy age matched controls
time frame: Dec 2009

Secondary Outcomes

Measure
Investigate immune responses and correlate with CLL prognostic markers
time frame: Dec 2009

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Untreated stage A CLL patients - Healthy volunteers Exclusion Criteria: - Patients with other malignancies - Patients receiving corticosteroids or other immunosuppressive drugs - Patients who have received vaccination against influenza in the past 6 months - Patients who have had an allergic reaction to a flu shot in the past, or have an allergy to eggs or who previously developed Guillain-Barré syndrome within 6 weeks of getting a flu shot - Patients failing to give informed consent. - Patients using homeopathic remedies such as echniaea cream.

Additional Information

Official title 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
Principal investigator Helen McCarthy, MBBS PhD
Description Trial Summary 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 this study. 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 or 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by The Royal Bournemouth Hospital.