Evaluation of Immunologic Response After Pandemic Influenza A (H1N1) Vaccine in Oncologic and Hematologic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- To assess antibody response (antibody titer > 1:40 or four-fold increase, geometric mean titer) in onco-hematologic patients and controls and whether this response changes over time
研究概览
简要总结
Primary objective
- To assess whether oncologic and hematologic patients develop a protective immunological response after pandemic Influenza A (H1N1) vaccine
Secondary objectives
- To compare the levels of antibody response against A (H1N1) influenza virus between oncologic and hematologic patients relative to a cohort of healthy volunteers
- To assess the incidence of A (H1N1) infection in vaccinated oncologic and hematologic patients in comparison with a cohort of vaccinated healthy volunteers. To assess the clinical symptoms attributable to influenza infection in vaccinated oncologic and hematological patients and healthy volunteers.
- To compare the levels of antibody response against A (H1N1) influenza virus between the following subgroups: patients with ongoing chemotherapy; patients who have completed the chemotherapy treatment; patients treated with autologous or allogeneic peripheral blood hematopoietic stem cell transplant (PBSCT)
Study procedures: Onco-hematological patients will perform a blood sample collection before the vaccination, on day +21 after vaccination , on day +50 and on day +90. At the end of the collection, the investigators will perform immunological test to evaluate the antibody titer and the cellular response. The titer of antibodies against the vaccine strain will be measured in all samples by hemagglutination-inhibition (HI) assays with the use of turkey erythrocytes and according to EMEA guidelines. Response criteria will be the achievement of a protective title of HI test > 1:40. In addition, the investigators will evaluate: geometric mean titers and a fourfold titer increase compared with prevaccination titers. Cellular-mediated response will be analysed by flow-cytometry. A control cohort of healthy volunteers who received A(H1N1) vaccine will perform the same blood sample collection.
Evaluation of clinical response: Oncologic and hematologic patients will be followed as outpatients or inpatients according to routine controls for their disease. In case that symptoms of the upper airways or influenza-like symptoms develop, the symptoms will be recorded in the clinical database, nasal and pharyngeal swaps will be performed according to the doctor who is taking care of the patient. In order to evaluate the clinical efficacy of the vaccination, the swaps will be tested for A (H1N1) influenza virus infection. No further studies will be performed after 3 months from the vaccination.
详细描述
Primary objective
- To assess whether oncologic and hematologic patients develop a protective immunological response after pandemic Influenza A (H1N1) vaccine Secondary objectives
- To compare the levels of antibody response against A (H1N1) influenza virus between oncologic and hematologic patients relative to a cohort of healthy volunteers
- To assess the incidence of A (H1N1) infection in vaccinated oncologic and hematologic patients in comparison with a cohort of vaccinated healthy volunteers. To assess the clinical symptoms attributable to influenza infection in vaccinated oncologic and hematological patients and healthy volunteers.
- To compare the levels of antibody response against A (H1N1) influenza virus between the following subgroups: patients with ongoing chemotherapy; patients who have completed the chemotherapy treatment; patients treated with autologous or allogeneic peripheral blood hematopoietic stem cell transplant (PBSCT) Study population and design
The study population consists consecutive patients with oncologic or hematologic diseases who are planned to receive A (H1N1) influenza vaccine
Study procedures The patients will perform a blood sample collection (serum vial) on day 0 (range: 0- 2 days before vaccination) before the vaccination, a blood sample collection (serum vial) on day +21 (range: +/- 5 days) after vaccination , a blood sample collection (serum vial) on day +50 (range: +/- 5 days) and on day +90 range: +/- 5 days) after vaccination. The samples will be frozen in 500 mcl aliquots at -20°C. At the end of the collection we will perform immunological test to evaluate the antibody titer and the cellular response. The serum samples will be stored at the laboratory of Virology of the University of Milan. The titer of antibodies against the vaccine strain will be measured in all samples by means of hemagglutination-inhibition (HI) assays with the use of turkey erythrocytes and according to EMEA guidelines. Response criteria will be the achievement of a protective title of HI test > 1:40. In addition we will evaluate: geometric mean titers and a fourfold titer increase compared with prevaccination titers. Cellular-mediated response will be analysed by incubating CD3+ patients' cells with influenza A Antigens and evaluation of: 1) cellular expansion by flow-cytometry analysis of dilution of carboxyfluorescein succinimidyl ester (CFSE); 2) IFN-gamma production by ELISPOT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Oncologic and hematologic patient with the plan of receiving the A (H1N1) vaccine
- •Control Group: a silent history for oncologic and hematologic diseases; planned of receiving the A (H1N1) vaccine
- •Written informed consent
排除标准
- •Infusion of human Immunoglobulin ongoing or within prior 30 days
- •Therapy with monoclonal or polyclonal antibodies ongoing or within prior 30 days
- •Therapy with IL-1 or IL-2 or IFN-gamma ongoing or within prior 30 days
- •Autologous PBSCT less than 1 month or Allogeneic PBSCT less than 6 months
- •Pregnancy or lactation
- •Type I hypersensitivity
- •Ongoing Anticoagulant therapy or platelets < 50000/ul
结局指标
主要结局
To assess antibody response (antibody titer > 1:40 or four-fold increase, geometric mean titer) in onco-hematologic patients and controls and whether this response changes over time
时间窗: Day 0, 30, 60, 90
The antibody titers against virus A/H1N1 will be measured in all samples by means of hemagglutination-inhibition (HI) assays with the use of turkey erythrocytes and according to EMEA guidelines. Antibody titers in control, patients and in different patient subgroups will be compared on different time points.
次要结局
- To assess whether controls or patients develop influenza like illness or symptoms.(Day 0, 30, 60, 90)
- To assess virus specific cell mediated response (by flow-cytometry evaluation) in onco-hematologic patients and controls and whether this response changes over time.(0, 30, 60, 90)
研究者
Paolo Corradini
Professor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano