Chronic Lymphocytic LeukemiaPhase 2CLLIFVACNCT00596336
Study of Immune Responses to Influenza Vaccination With or Without Imiquimod Application in Untreated CLL Patients
A Phase 2 study testing Imiquimod cream and influenza vaccine in people with Chronic Lymphocytic Leukemia, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Imiquimod cream and influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2007to 15 Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Untreated stage A CLL patients
- Healthy volunteers
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Bournemouth hospital
Bournemouth, Dorset, BH7 7DW
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Imiquimod cream, influenza vaccine
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imiquimod creamDrug
Also called Aldara cream
Imiquimod (aldara) 0.5 % cream to site of vaccination on day 2 to 6
influenza vaccineDrug
Also called influvac sub-unit
trispecific influenza vaccine 0.5 ml subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Group A CLL patients | Active comparator | Vaccination with current trispecific influenza vaccine Day 1 Receives: 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. Receives: Drug: Imiquimod cream; Drug: influenza vaccine |
| Group C volunteers | Active comparator | Vaccination with current trispecific influenza vaccine Day 1 Receives: Drug: influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune responses to influenza vaccine in CLL cohorts and healthy age matched controls
Measured: Dec 2009
Secondary outcomes (1)
Investigate immune responses and correlate with CLL prognostic markers
Measured: Dec 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2011
- Study completion15 Mar 2017
Why it stopped: Recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Bournemouth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CLL Topics, Inc.
- Responsible party
- Sponsor
- Investigators
- Helen McCarthy, MBBS PhD, Principal investigator, Royal Bournemouth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596336
- Sponsor's protocol ID
- Eudract number: 2006-004902-16
- Other IDs
- LREC number: 06/Q2201/143
- Acronym
- CLLIFVAC
- Status last verified
- Apr 2017
- First submitted
- 8 Jan 2008
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00596336
- Acronym / sponsor ID
- CLLIFVAC / Eudract number: 2006-004902-16
- Conditions
- Chronic Lymphocytic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issues
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Royal Bournemouth HospitalUniversity, hospital or other
- Collaborators
- CLL Topics, Inc.
- Study start
- Oct 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A CLL patients | Active comparator | Drug: influenza vaccineVaccination with current trispecific influenza vaccine Day 1 |
| Group B CLL patients | Experimental | Drug: Imiquimod cream, Drug: influenza vaccineVaccination with current trispecific influenza vaccine Day 1, together with the application of Imiquimod cream to the vaccination site on day 2 to 6. |
| Group C volunteers | Active comparator | Drug: influenza vaccineVaccination with current trispecific influenza vaccine Day 1 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Untreated stage A CLL patients
- Healthy volunteers
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imiquimod creamAlso: Aldara creamImiquimod (aldara) 0.5 % cream to site of vaccination on day 2 to 6 | Drug | Group B CLL patients |
| influenza vaccineAlso: influvac sub-unittrispecific influenza vaccine 0.5 ml subcutaneously | Drug | Group A CLL patients, Group B CLL patients, Group C volunteers |
Primary outcome
Immune responses to influenza vaccine in CLL cohorts and healthy age matched controls
Time frame: Dec 2009
1 secondary outcome
Investigate immune responses and correlate with CLL prognostic markers
Time frame: Dec 2009
Results and safety
The study was stopped early (reason given: Recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen McCarthy, MBBS PhD principal investigator
Royal Bournemouth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imiquimod cream and influenza vaccine in people with Chronic Lymphocytic Leukemia, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune responses to influenza vaccine in CLL cohorts and healthy age matched controls (time frame: Dec 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.