EUCTR2018-003377-97-SE进行中（未招募）1 期
ong term effect on immune response after pneumococcal vaccination in patients with chronic lymphocytic leukemia and evaluation of the effect of revaccination.
Swedish CLL-group0 个研究点目标入组 126 人开始时间: 2018年11月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •CLL patients
- •CLL patients earlier included in the Pneumococcal vaccination study 0887x1-20003 (EudraCT No: 2009-012642-22), who have received either PCV13 or PPSV23 are eligible for evaluation of the long-term immune response. The median age of the patient group was at inclusion 70 years (range 46-87) with an equal number men and women (65/63). The same patients are eligible for revaccination if they do not meet any exclusion criteria. Ongoing or recent CLL specific treatment is not an exclusion criteria.
- •A control group (n=40) of immunocompetent subjects will be recruited in Region Örebro County. The control group will be matched to the CLL group by age and gender. For inclusion they should have been vaccinated with either PCV13 (n=20) or PPSV23 (n=20) approximately 3-5 years ago and not meet any exclusion criteria. They will subsequently be eligible for long-term immune response and revaccination according to the study protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 41
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 105
排除标准
- •CLL patients
- •1.Patients receiving high dose corticosteroids ( =20 mg Prednisolone) or other immunosuppressive drugs that is not part of active CLL treatment
- •2.Patients who have had an allergic reaction to any vaccination in the past
- •3.Patients with a positive DAT (Direct Antiglobulin Test) or known present or previous hemolysis, ITP and Guillain-Barre
- •4.Patients failing to give informed consent
- •5.Patients with ongoing immunoglobulin therapy
- •6.Patients with known HIV infection
- •7.Patients who have received a pneumococcal vaccine outside the study protocol within the last 12 months
- •8.Active febrile infection
- •9.Increased bleeding risk due to severe thrombocytopenia or other coagulopathies that would, in the opinion of the investigator, contraindicate intramuscular injection
- •1.Serious chronic disorder including chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen treatment, end-stage renal disease, clinically unstable cardiac disease or any other disorder that, in the investigator’s opinion, excludes the subject from participating in the study;
- •2.Known or suspected immunodeficiency or other conditions associated with immunosuppression including immunoglobulin class/subclass deficiencies with or without substitution treatment, splenectomy in the medical history, generalized malignancy, human immunodeficiency virus (HIV) infection, haematological malignancies, bone marrow or organ transplant in the medical history;
- •3.Subjects receiving treatment with high dose corticosteroids (=20 mg Prednisolone) or other immunosuppressive drugs, or planned to receive through study participation;
- •4.Subjects who have had an allergic reaction to any component of PCV13 in the past;
- •5.Subjects with known present or previous hemolysis, ITP and Guillain-Barre;
- •6.Subjects failing to give informed consent;
- •7.Subjects who have received a pneumococcal vaccine after the primary vaccination aproximately 3-5 years ago;
- •8.Active febrile infection;
- •1.9.Increased bleeding risk due to severe thrombocytopenia or other coagulopathies that would, in the opinion of the investigator, contraindicate intramuscular injection (for treatment with oral anticoagulation therapy, see section 7.3).
研究者
相似试验
进行中（未招募）
不适用
Immunogenicity of pneumococcal vaccination after prime boosting in HIV-Infected Adults: A Randomised Controlled TrialThe primary objectives of this study are to:1.Prospectively evaluate immunological response to vaccination with the 23-valent polysaccharide vaccine (PPV23) in HIV infected patients over a one year period.2.Evaluate whether a strategy combining a prime with the 13-valent conjugate pneumococcal vaccine (PCV) followed by a boost with the PPV23 would improve immunogenicity against Streptococcus Pneumoniae Polysaccharides (SPP) in HIV-infected patients.EUCTR2011-000260-99-IEDepartment of Genitourinary medicine and Infectious Diseases, St James's Hospital, Dublin 8150
进行中（未招募）
不适用
Regulatory role of the immune system of Prevenar 13 vaccine in children with asthma and diabetes.Allergic asthma and type 1 diabetes mellitus in pediatric subjects.EUCTR2014-004799-50-ESFederico Martinon Torres
进行中（未招募）
1 期
ong-term follow-up study of immune response to vaccinations with RV001 in patients enrolled in RhoVac-001 studyProstate cancerEUCTR2020-004705-31-DKRhoVac ApS22
已完成
4 期
Immune Response After Pneumococcal Vaccination in Patient With Chronic Lymphocytic LeukemiaVaccine ResponseCLLNCT05316831Region Örebro County77
进行中（未招募）
不适用
Immune response to pneumococcal conjugate vaccine in adults receiving hepatitis A vaccine concomitantly18 years old or older volunteers with general good healthEUCTR2012-003484-22-FIHelsinki University Central Hospital600