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

NCT00596336 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-04-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Imiquimod cream

Imiquimod (aldara) 0.5 % cream to site of vaccination on day 2 to 6

DRUG

influenza vaccine

trispecific influenza vaccine 0.5 ml subcutaneously

Sponsors & Collaborators

  • CLL Topics, Inc.

    collaborator OTHER

  • The Royal Bournemouth Hospital

    lead OTHER

Principal Investigators

  • Helen McCarthy, MBBS PhD · Royal Bournemouth Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-12-31
Completion
2017-03-15

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00596336 on ClinicalTrials.gov