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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Immune responses to influenza vaccine in CLL cohorts and healthy age matched controls
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Untreated stage A CLL patients
- •Healthy volunteers
排除标准
- •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.
研究组 & 干预措施
Group A CLL patients
Vaccination with current trispecific influenza vaccine Day 1
干预措施: influenza vaccine (Drug)
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.
干预措施: Imiquimod cream (Drug)
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.
干预措施: influenza vaccine (Drug)
Group C volunteers
Vaccination with current trispecific influenza vaccine Day 1
干预措施: influenza vaccine (Drug)
结局指标
主要结局
Immune responses to influenza vaccine in CLL cohorts and healthy age matched controls
时间窗: Dec 2009
次要结局
- Investigate immune responses and correlate with CLL prognostic markers(Dec 2009)