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

NCT00596336 | Terminated Phase 2

• 2 other identifiers: Eudract number: 2006-004902-16LREC number: 06/Q2201/143
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Immune responses to influenza vaccine in CLL cohorts and healthy age matched controls

  Dec 2009

Secondary Outcomes (1)

• Investigate immune responses and correlate with CLL prognostic markers

  Dec 2009

Study Arms (3)

Group A CLL patients

ACTIVE COMPARATOR

Vaccination with current trispecific influenza vaccine Day 1

Drug: influenza vaccine

Group B CLL patients

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.

Drug: Imiquimod cream; Drug: influenza vaccine

Group C volunteers

ACTIVE COMPARATOR

Vaccination with current trispecific influenza vaccine Day 1

Drug: influenza vaccine

Interventions

Imiquimod cream DRUG

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

Also known as: Aldara cream

Group B CLL patients

influenza vaccine DRUG

trispecific influenza vaccine 0.5 ml subcutaneously

Also known as: influvac sub-unit

Group A CLL patients; Group B CLL patients; Group C volunteers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Untreated stage A CLL patients
• Healthy volunteers

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Royal Bournemouth Hospital: lead
• CLL Topics, Inc.: collaborator

Study Sites (1)

Royal Bournemouth hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Helen McCarthy, MBBS PhD

  Royal Bournemouth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 17, 2008
• Study Start: October 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: March 15, 2017
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

GB (1)