Study of Immune Responses to Influenza Vaccination With or Without Imiquimod Application in Untreated CLL Patients (CLLIFVAC)

April 11, 2017 updated by: The Royal Bournemouth Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A CLL patients
Vaccination with current trispecific influenza vaccine Day 1
Drug: influenza vaccine
trispecific influenza vaccine 0.5 ml subcutaneously
Other Names:
  • influvac sub-unit
Experimental: Group B CLL patients
Vaccination with current trispecific influenza vaccine Day 1, together with the application of Imiquimod cream to the vaccination site on day 2 to 6.
Drug: influenza vaccine
trispecific influenza vaccine 0.5 ml subcutaneously
Other Names:
  • influvac sub-unit
Drug: Imiquimod cream
Imiquimod (aldara) 0.5 % cream to site of vaccination on day 2 to 6
Other Names:
  • Aldara cream
Active Comparator: Group C volunteers
Vaccination with current trispecific influenza vaccine Day 1
Drug: influenza vaccine
trispecific influenza vaccine 0.5 ml subcutaneously
Other Names:
  • influvac sub-unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immune responses to influenza vaccine in CLL cohorts and healthy age matched controls
Time Frame: Dec 2009
Dec 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
Investigate immune responses and correlate with CLL prognostic markers
Time Frame: Dec 2009
Dec 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Royal Bournemouth Hospital

Collaborators

CLL Topics, Inc.

Investigators

  • Principal Investigator: Helen McCarthy, MBBS PhD, Royal Bournemouth Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

March 15, 2017

Study Registration Dates

First Submitted

January 8, 2008

First Submitted That Met QC Criteria

January 8, 2008

First Posted (Estimate)

January 17, 2008

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Eudract number: 2006-004902-16
  • LREC number: 06/Q2201/143

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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